Active tDCS Research Articles

Effects of psychoeducation combined with transcranial direct current stimulation on reducing cigarette craving and consumption in male smokers

Psychoeducation (PE) has been widely used in smoking interventions, but its long-term effects are limited. Recent studies have reported that, in some fields, a combination of transcranial direct current stimulation (tDCS) and cognitive training (e.g., working memory tasks) may improve cognitive outcomes; thus, we aimed to investigate whether such a combined intervention has a better effect than a PE intervention for reducing smoking cravings and cigarette consumption. In Exp. 1, 19 male smokers received four types of interventions at one-week intervals. In each session, participants were presented with audio PE (or control) while receiving 2-mA active (or sham) tDCS of the dorsolateral prefrontal cortex (DLPFC). In Exp. 2, 48 male smokers were randomized into four experimental groups (PE + Active, Control + Active, PE + Sham, or Control + Sham). Each participant received one type of five-day intervention (i.e., watching a five-minute PE/Control video twice while receiving 2-mA active/sham tDCS) and was followed up for one week. The results showed (a) an enhancement effect of tDCS on PE’s ability to reduce cigarette consumption; (b) that repeated PE has a cumulative effect on reducing both craving and cigarette consumption during the intervention period; and (c) that, compared with PE alone, PE combined with tDCS is capable of helping participants maintain a low intake of cigarettes over one week. These findings suggest that repeated interventions of PE combined with tDCS may be effective in reducing smoking consumption and that further studies are warranted to confirm its application.

Treating fibromyalgia with electrical neuromodulation: A systematic review and meta-analysis

ObjectiveSeveral types of electrical neuromodulation (such as transcranial direct current stimulation, tDCS; transcutaneous electrical nerve stimulation) have been applied in the treatment of fibromyalgia. These trials had different outcome measurements, such as subjective pain, pain threshold, depression, anxiety, and functioning. We intended to integrate data from different trials into a meta-analysis to clearly present the clinical value of electrical neuromodulation in fibromyalgia. MethodsA systematic review and meta-analysis of randomized controlled trials comparing the effect of all types of electrical neuromodulation in patients with fibromyalgia was conducted. The main outcome was subjective pain; the secondary outcomes included depression, anxiety, and functioning. ResultsTwenty-five studies and 1061 fibromyalgia patients were included in the quantitative analysis. Active electrical neuromodulation and active tDCS both showed significant effects on subjective pain, depression, and functioning. For different anode tDCS electrode positions, only F3-F4 revealed a significant effect on depression. Meta-regression tDCS effects on depression were significantly associated with age. ConclusionsElectrical neuromodulation is significantly effective in treating pain, depression, and functioning in patients with fibromyalgia. SignificanceThe results may help clinicians to arrange effective treatment plans for patients with fibromyalgia, especially in those patients who reveal limited response to pharmacotherapy and psychotherapy.

Transcranial direct current stimulation (tDCS) to dorsolateral prefrontal cortex influences perceived pleasantness of food

The ability to regulate the intake of unhealthy foods is critical in modern, calorie dense food environments. Frontal areas of the brain, such as the dorsolateral prefrontal cortex (DLPFC), are thought to play a central role in cognitive control and emotional regulation. Therefore, increasing activity in the DLPFC may enhance these functions which could improve the ability to reappraise and resist consuming highly palatable but unhealthy foods. One technique for modifying brain activity is transcranial direct current stimulation (tDCS), a non-invasive technique for modulating neuronal excitability that can influence performance on a range of cognitive tasks. We tested whether anodal tDCS targeting the right DLPFC would influence how people perceived highly palatable foods. In the present study, 98 participants were randomly assigned to receive a single session of active tDCS (2.0 mA) or sham stimulation. While receiving active or sham stimulation, participants viewed images of highly palatable foods and reported how pleasant it would be to eat each food (liking) and how strong their urge was to eat each food (wanting). We found that participants who received active versus sham tDCS stimulation perceived food as less pleasant, but there was no difference in how strong their urge was to eat the foods. Our findings suggest that modulating excitability in the DLPFC influences “liking” but not “wanting” of highly palatable foods. Non-invasive brain stimulation might be a useful technique for influencing the hedonic experience of eating but more work is needed to understand when and how it influences food cravings.

Left Prefrontal tDCS during Learning Does Not Enhance Subsequent Verbal Episodic Memory in Young Adults: Results from Two Double-Blind and Sham-Controlled Experiments.

Recent studies suggest that transcranial direct current stimulation (tDCS) applied over the prefrontal cortex (PFaC) may enhance episodic memory ability. As such, there is ongoing interest in the therapeutic potential of this technique in age-related memory decline. At the same time, the findings are not yet conclusive regarding the magnitude of this effect, and assumptions regarding underlying brain mechanisms of stimulation-induced changes in behaviour are yet to be tested in detail. Here, we evaluated the effect of tDCS over left PFC on verbal episodic memory in young adults. Two separate randomized, double-blind, sham-controlled experiments were carried out using (1) incidental learning followed by a recognition test and (2) intentional learning followed by a free recall. In both studies, participants performed a learning task with active or sham tDCS during the encoding period, followed by retrieval tasks on the same day and the next day. The results suggest that, contrary to expectations, active tDCS did not enhance memory performance relative to sham tDCS. Possible reasons behind the lack of enhancement effects are discussed, including the possibility that memory enhancement effects of tDCS may be smaller than first thought. Scientific practices that could improve estimation accuracy in the field are also discussed.

The effects of left dorsolateral prefrontal transcranial direct current stimulation on episodic future thinking following acute psychosocial stress

ABSTRACT Introduction Research on stress-related disorders and brain imaging suggests that (acute) stress might impact the capacity to mentally simulate specific episodic future events (EFT) through the effects of cortisol on brain regions supporting this cognitive function, such as the prefrontal cortices. This study aims to examine the mechanisms underlying this link, using transcranial Direct Current Stimulation (tDCS) over the left dorsolateral prefrontal cortex. Methods 60 healthy participants were subjected to the Montreal Imaging Stress Task (MIST), followed by either active or sham tDCS. After stimulation, the EFT task was administered. Salivary cortisol was measured throughout the protocol. Results Higher cortisol AUCi values were linked to less specific episodic future thoughts. Moreover, active tDCS enhanced EFT specificity irrespective of cortisol, especially in high trait ruminators. We did not observe an effect from active tDCS on cortisol AUCi, and equally there was no interaction effect between cortisol AUCi and stimulation condition predictive for EFT specificity. Conclusion Although we did not find evidence for the effects of tDCS on the HPA-system, our data reveal a crucial link between two critical predictors of mental health for the first time, and provide a solution to help rehabilitate EFT deficits. Trial registration: Netherlands National Trial Register identifier: ntr004..

Effects of Anodal Transcranial Direct Current Stimulation on the Primary Motor Cortex in Women With Fibromyalgia: A Randomized, Triple-Blind Clinical Trial

ObjectivesThe aim of this study was to analyze the effects of ten sessions of active transcranial direct current stimulation transcranial direct current stimulation (tDCS) (2 mA) with 13:20:13 stimulation at M1 in women with fibromyalgia (FM). To the best of our knowledge, this is the first article that uses this protocol in patients with FM. The main hypothesis is that the protocol would be effective in decreasing pain and that the results would last for up to 90 days. Materials and MethodsThis study was a randomized clinical trial with 35 women with FM divided into two groups, active tDCS group and sham tDCS group. A conventional tDCS device was used to deliver 2 mA for 13 minutes, with a 20-minute break followed by a further 13 minutes of stimulation for ten sessions. The anodal stimulus was in the left primary motor cortex M1 region. The primary outcome was a change in the visual analog scale and the Survey of Pain Attitudes pain score at the end of treatment, after 30 days, and 90 days after the end of treatment. Secondary outcomes included changes in the Fibromyalgia Impact Questionnaire, Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, World Health Organization's Quality of Life Questionnaire, and Fatigue Assessment Scale. The Research Ethics Committee of the Centro Universitário da Grande Dourados under registration number Certificado de Apresentação de Apreciação Ética approved this research: 36444920.5.0000.5159. The study was registered in The Brazilian Registry of Clinical Trials with the identifier RBR-8wc8rjq. ResultsThe active tDCS group showed improvement in pain after ten sessions (p < 0.001), after 30 days (p < 0.01), and after 90 days (p < 0.001) compared with sham tDCS. In addition, improvement in quality of life (QoL) and fatigue was observed in the active tDCS group. ConclusionThe results of this study suggest that active tDCS with an intensity of 2 mA for ten sessions was effective in decreasing pain and fatigue and improving QoL in patients with FM.

Feasibility, Acceptability, and Efficacy of Home-Based Transcranial Direct Current Stimulation on Pain in Older Adults with Alzheimer's Disease and Related Dementias: A Randomized Sham-Controlled Pilot Clinical Trial.

Although transcranial direct current stimulation (tDCS) is emerging as a convenient pain relief modality for several chronic pain conditions, its feasibility, acceptability, and preliminary efficacy on pain in patients with Alzheimer's disease and related dementias (ADRD) have not been investigated. The purpose of this pilot study was to assess the feasibility, acceptability, and preliminary efficacy of 5, 20-min home-based tDCS sessions on chronic pain in older adults with ADRD. We randomly assigned 40 participants to active (n = 20) or sham (n = 20) tDCS. Clinical pain intensity was assessed using a numeric rating scale (NRS) with patients and a proxy measure (MOBID-2) with caregivers. We observed significant reductions of pain intensity for patients in the active tDCS group as reflected by both pain measures (NRS: Cohen's d = 0.69, p-value = 0.02); MOBID-2: Cohen's d = 1.12, p-value = 0.001). Moreover, we found home-based tDCS was feasible and acceptable intervention approach for pain in ADRD. These findings suggest the need for large-scale randomized controlled studies with larger samples and extended versions of tDCS to relieve chronic pain on the long-term for individuals with ADRD.

Home-based transcranial direct current stimulation in mild neurocognitive disorder due to possible Alzheimer's disease. A randomised, single-blind, controlled-placebo study.

Mild neurocognitive disorder (mNCD), a pre-dementia stage close to Mild Cognitive Impairment, shows a progressive and constant decline in the memory domain. Of the non-pharmacological therapeutic interventions that may help to decelerate the neurodegenerative progress, transcranial direct current stimulation (tDCS) shows beneficial effects on the learning curve, immediate recall, immediate verbal memory and executive functions. The purpose of this research was to study the effect of tDCS on general cognition, immediate and delayed memory and executive functions by comparing an active group with a placebo group of mNCD patients. Participants were 33 mNCD due to possible AD, randomly assigned to two groups: 17 active tDCS and 16 placebo tDCS. Ten sessions of tDCS were conducted over the left dorsolateral prefrontal cortex. Several neuropsychological scales were administered to assess the primary outcome measures of general cognitive function, immediate and delayed memory and learning ability, whereas the secondary outcome measures included executive function tests. All participants were evaluated at baseline and at the end of the intervention. Mixed ANOVAs were performed. Significant effects were obtained on general cognitive function, immediate and delayed memory and learning ability, with increases in scores in the active tDCS group. However, there were no significant effects on executive function performance. The present study demonstrated the effectiveness of tDCS in an active tDCS group, compared to a placebo group, in improving general cognition and immediate and delayed memory, as previous studies found. Taken together, our data suggest that tDCS is a simple, painless, reproducible and easy technique that is useful for treating cognitive alterations found in neurodegenerative diseases.

The effects of high-definition transcranial direct current stimulation on pain modulation and stress-induced hyperalgesia.

The dorsolateral prefrontal cortex (DLPFC) has been implicated in the modulation of pain-related signals. Given this involvement, manipulation of the DLPFC through transcranial direct current stimulation (tDCS) may influence internal pain modulation and decrease pain sensitivity. Acute stress is also thought to affect pain, with increased pain sensitivity observed following the presentation of an acute stressor. A total of 40 healthy adults (50% male), ranging in age from 19 to 28 years (M = 22.13, SD = 1.92), were randomly allocated to one of two stimulation conditions (active and sham). High-definition tDCS (HD-tDCS) was applied for 10min at 2mA, with the anode placed over the left DLPFC. Stress was induced after HD-tDCS administration using a modified version of the Trier Social Stress Test. Pain modulation and sensitivity were assessed through the conditioned pain modulation paradigm and pressure pain threshold measurements, respectively. Compared to sham stimulation, active stimulation produced a significant increase in pain modulation capacity. No significant change in pain sensitivity and stress-induced hyperalgesia was observed following active tDCS. This research shows novel evidence that anodal HD-tDCS over the DLPFC significantly enhances pain modulation. However, HD-tDCS had no effect on pain sensitivity or stress-induced hyperalgesia. The observed effect on pain modulation after a single dose of HD-tDCS over the DLPFC is a novel finding that informs further research into the utility of HD-tDCS in the treatment of chronic pain by presenting the DLPFC as an alternative target site for tDCS-induced analgesia.

Home-based transcranial direct current stimulation combined with behavioral therapy delivered through smartphone to treat major depressive disorder: a randomized, double-blind placebo-controlled trial

Abstract Major depressive disorder (MDD) is the leading cause of disability worldwide. First-line treatments, antidepressants, and cognitive behavioral therapy (CBT), have significant side effects and limited availability, respectively. Transcranial direct current stimulation (tDCS) has been studied in the last two decades as a therapeutic alternative for MDD. tDCS demonstrates good efficacy, safety and tolerability, both as monotherapy and associated with antidepressants and/or psychotherapy. tDCS is a simple procedure that can be performed at home with remote supervision and can possibly be enhanced by combining it with self-directed CBT modalities via smartphone applications. We will present data from a randomized, double-blind, placebo-controlled clinical trial aiming to evaluate the efficacy, safety, tolerability and usability of home-based tDCS combined with behavioral therapy (BT) delivered through smartphone. The study includes 3 arms: (1) active tDCS + active BT, (2) active tDCS + placebo BT and (3) sham-tDCS + placebo BT. Twenty-one sessions of home-based tDCS + BT will be applied, for 6 weeks, ,in patients between 18-59 years, diagnosed with MDD, without contraindications for tDCS, with a smartphone for personal use and internet access at home. Participants are not asked to washout of antidepressant to enter the study. The active tDCS protocol will include daily tDCS sessions at 2mA, for 30 minutes, with the anode and cathode positioned over the left and right prefrontal cortex, respectively. The Flow (Flow Neuroscience, Malmö, Sweden) tDCS equipment and BT application will be used. The results of this study will contribute to the development of home-based tDCS systems, offering a better understanding of the combined effects of tDCS with potentiating strategies (e.g. BT), known to modulate the functioning of key areas in the neurobiology of MDD, such as the dorsolateral prefrontal cortex. Research Category and Technology and Methods Clinical Research: 9. Transcranial Direct Current Stimulation (tDCS) Keywords: tDCS, Home-based, RCT, Behavioral Therapy

Ensaio clínico randomizado sobre a eficácia de novo equipamento de estimulação transcraniana por corrente contínua (ETCC) no tratamento da depressão: uma opção de baixo custo para países em desenvolvimento?

ABSTRACT Objective: Verify the clinical efficacy and safety of a low-cost tDCS device, in a clinical trial for major depressive disorder. Methods: 168 persons were recruited; 32 depressed individuals with moderate or severe depressive symptoms (HDRS17 scores higher than 18) were included and randomized for the trial (16 individuals in each group). The intervention consisted of 10 active anodal tDCS sessions at 2 mA for 30 minutes over the left dorsolateral prefrontal cortex; or sham. The main outcome was HDRS17; secondary outcomes included satisfaction (TSQM II) and quality of life (WHOQOL-BREF). Assessments at baseline, endpoint and at 30 days follow-up. Results: The sample was composed by a total of 11 men and 21 women, mean age of 42.75 years (95% CI: 38.10-47.40). Active treatment was superior than sham: There was a significant interaction between group and time regarding HDRS-17 scores (F = 4.089, df = 2, p = 0.029; partial Eta squared = 0. 239). Post hoc analyses exhibited a statistically significant difference between active and sham group symptoms after a 30 days follow-up (difference = -7.75, p = 0.008, Cohen’s d = 1.069). There were 3 dropouts, all in the active group, due schedule issues. No severe adverse effects reported. Conclusion: The current active tDCS protocol was related with clinical improvement of depressive symptoms. Intervention was well-tolerated. Non-invasive brain stimulation techniques are still not routinely used, although a viable strategy for treatment-resistant patients, partial responders and people unable to use pharmacological treatment. We aim to increase knowledge and use of tDCS for the Brazilian population.

Methylphenidate is more effective to improve inhibitory control and working memory compared to tDCS in children and adolescents with attention deficit/hyperactivity disorder: a proof-of-concept study.

Attention-deficit/hyperactivity disorder (ADHD) is characterized by an inappropriate, pervasive and persistent pattern of inattention, hyperactivity, and/or impulsivity and associated with substantial functional impairment. Despite considerable advances in the understanding and management of ADHD, some patients do not respond well to methylphenidate (MPH), the first-choice pharmacological treatment. Over the past decades, among non-invasive brain stimulation techniques, transcranial direct current stimulation (tDCS) has proven to be an effective and safe technique to improve behavior and cognition in children with neurodevelopmental disorders, including ADHD, by modifying cortical excitability. However, the effect of tDCS has never been directly compared with that of the MPH. The present randomized sham-controlled trial evaluated the effect of a single session of anodal tDCS compared with the administration of a single dose of MPH in children and adolescents with ADHD. After completing baseline assessment (T0), 26 children and adolescents with ADHD were exposed to 3 conditions with a 24-h interval-sessions: (A) a single session of anodal tDCS over the left dorsolateral prefrontal cortex (DLPFC); (B) a single session of sham tDCS over the left DLPFC; (C) a single dose of MPH. Our results showed that after administering a single dose of MPH, children and adolescents with ADHD improved inhibitory control and visual-spatial WM compared with baseline, anodal, and sham tDCS. However, a single session of active tDCS over the left DLPFC was not effective compared with either baseline or sham tDCS. In conclusion, our protocol in ADHD involving a single tDCS session did not demonstrate consistent improvements in neurocognitive features compared with baseline, sham tDCS, or single MPH administration. Different protocols need to be developed to further test the effectiveness of tDCS in improving ADHD symptoms.

Clinical Practice Guidelines for the Use of Transcranial Direct Current Stimulation in Psychiatry.

Clinical Practice Guidelines for the Use of Transcranial Direct Current Stimulation in Psychiatry.

Early transcranial direct current stimulation with modified constraint-induced movement therapy for motor and functional upper limb recovery in hospitalized patients with stroke: A randomized, multicentre, double-blind, clinical trial

BackgroundConstraint-induced movement therapy (CIMT) and transcranial direct current stimulation (tDCS) are used to reduce interhemispheric imbalance after stroke, which is why the combination of these therapies has been used for neurological recovery, but not in the acute phase. ObjectivesTo evaluate the effectiveness of combining active or sham bihemispheric tDCS with modified CIMT (mCIMT) for the recovery of the Upper Limb (UL) in hospitalized patients with acute and subacute stroke. MethodsThis randomized controlled, double-blind, placebo-controlled, parallel group clinical trial was executed between September 2018 to March 2021 recruited 70 patients. The patients were randomized to one of two groups to receive treatment for 7 consecutive days, which included 20 min of active or sham bihemispheric tDCS daily (anodal ipsilesional and cathodal contralesional), with an mCIMT protocol. The primary outcome was the difference in the evolution of motor and functional upper limb recovery with assessment on days 0, 5, 7, 10 and 90. The secondary outcomes were independence in activities of daily living (ADL) and quality of life. ResultsThe active group presented a statistically significant gap compared to the simulated group throughout the trend in the scores of the FMA (motor function and joint pain) and WMFT (functional ability and weight to box) (p < 0.05) and showed a minimal clinically important difference (FMA: difference between groups of 4.9 points [CI: 0.007- 9.799]; WMFT: difference between groups of 6.54 points [CI: 1.10-14.15]). In the secondary outcomes, there was a significant difference between the groups in ADL independence (Functional Independence Measure: difference of 8.63 [CI: 1.37-18.64]) and perceived recovery of quality of life evaluated at 90 days (p = 0.0176). ConclusionsCombining mCIMT with bihemispheric tDCS in patients hospitalized with acute-subacute stroke allows us to maximize the motor and functional recovery of the paretic upper limb in the early stages and independence in ADL, maintaining the effects over time.

The effect of tDCS electrode montage on attention and working memory

The effects of transcranial direct current stimulation (tDCS) for improving attention and working memory have been generally mixed and small, potentially due to variability between studies with montages, stimulus parameters and outcome measures. The tDCS montage is an important parameter which determines the degree and intensity of stimulation in targeted brain regions. This study aimed to examine the effects of using three different montages for modulating attention and working memory performance: Bi-frontal, Broad-frontal and Broad-parietal. Ninety-three healthy adults participated in a counterbalanced cross-over study. Participants received both active and sham tDCS with either the Bi-frontal, Broad-frontal or Broad-parietal montage during performance of both a 1- and 2-back task. TDCS montage moderated 2-back working memory reaction time performance, though not accuracy, with faster reaction times observed for active compared to sham tDCS with the Broad-frontal montage only (F (1,90) = 5.26, p = .024, η2 = 0.06). TDCS montage did not significantly moderate performance on the 1-back task. The cognitive effects of tDCS varied according to montage, task, and outcome measure. TDCS administered with the cathode placed extracephalically in a Broad-frontal montage may be beneficial for improving working memory.

HOME-BASED TRANSCRANIAL DIRECT CURRENT STIMULATION AND CLINICAL PAIN IN OLDER ADULTS: A RANDOMIZED CLINICAL STUDY

Abstract Knee osteoarthritis (OA) is one of the leading causes of pain in older adults. Previous studies indicated clinic-based transcranial direct current stimulation (tDCS) was effective to reduce pain in various populations, but no published studies have reported the efficacy of home-based self-administered tDCS in older adults with knee OA using randomized clinical study. Thus, the purpose of this study was to evaluate the efficacy and safety of tDCS on clinical pain intensity in adults with knee OA pain. One hundred twenty participants aged 50–85 years with knee OA pain were randomly assigned to receive fifteen daily sessions of 2 mA tDCS for 20 min (n = 60) or sham tDCS (n = 60) over 3 weeks with remote supervision via telehealth. Clinical pain intensity was measured by asking participants to rate their knee pain using a numeric rating scale from 0 (no pain) to 100 (worst pain imaginable). Participants (68% female) had a mean age of 66 years and the mean body mass index in the sample was 32.59 kg/m2. There have been no adverse events. Active tDCS significantly reduced pain intensity compared to sham tDCS after completion of the fifteen daily sessions (t = 6.57, df = 110, p &amp;lt; .001). We demonstrated that home-based self-administered tDCS was safe and reduced clinical pain intensity in older adults with knee OA, which can increase its accessibility. Future studies with multi-site randomized controlled trials with various populations are needed to validate our findings.

Neurologic music therapy combined with EEG-tDCS for upper motor extremity performance in patients with corticobasal syndrome: Study protocol for a novel approach

BackgroundCorticobasal syndrome (CBS) is an atypical parkinsonian disorder that involves degeneration of brain regions associated with motor coordination and sensory processing. Combining transcranial direct current stimulation (tDCS) with rehabilitation training has been shown to improve upper-limb performance in other disease models. Here, we describe the protocol investigating whether tDCS with neurologic music therapy (NMT) (patterned sensory enhancement and therapeutic instrumental music performance) enhances functional arm/hand performance in individuals with CBS. MethodsStudy participants are randomly assigned to six 30-min sessions (twice per week for 3 weeks) of NMT + either sham tDCS or active tDCS. We aim to stimulate the frontoparietal cortex, which is associated with movement execution/coordination and sensory processing. The hemisphere contralateral to the more affected arm is stimulated (total stimulation current of 2 mA from 5 dime-sized electrodes). Individualized NMT sessions designed to exercise the upper limb are provided. Participants undergo gross/fine motor, cognitive and emotional assessments at baseline and follow-up (one month after the final session). To investigate the immediate effects of tDCS and NMT training, gross /fine motor, affective level, and kinematic parameter measurements using motion sensors are collected before and after each session. Electroencephalography is used to collect electrical neurophysiological responses before, during, and after tDCS+NMT sessions. The study participants, neurologic music therapist and outcome assessor are blinded to whether participants are in the sham or active tDCS group. ConclusionThis noninvasive and patient-centered clinical trial for CBS may provide insight into rehabilitation options that are sorely lacking in this population.

Efficacy of adjunctive intensive transcranial direct current stimulation of different cortices in treatment-resistant depression: a study protocol for a randomized double-blinded sham-controlled trial

BackgroundTreatment-resistant depression (TRD) carries a high economic burden worldwide. Transcranial direct current stimulation (tDCS) is advantageous for improving cognition and can be safely used in the treatment of depression. The effectiveness of tDCS of the left and right orbitofrontal cortex (OFC) as adjuvant treatment in patients with TRD has rarely been explored. Therefore, the objective of this trial is to evaluate the effectiveness there of when administering left dorsolateral prefrontal cortex (DLPFC) positive stimulation or OFC negative stimulation in patients with TRD.MethodsNinety eligible participants will be recruited to receive intervention at Shanghai Mental Health Center. Treatment will be randomly assigned in a double-blind fashion. Participants will receive either DLPFC (n = 30), OFC (n = 30), or sham (n = 30) tDCS, while continuing their usual pharmacotherapy at a stable dosage for at least 2 weeks before enrollment and throughout the stimulation period. All participants will receive 20 weekday stimulation sessions of 60 minutes duration each. Participants in the active group will be stimulated at 2 mA throughout the session, whereas the sham group will receive only a brief period of stimulation to mimic the sensation. After 20 stimulation sessions, no further treatment will be administered. Measurements will be conducted at regular points throughout and at 8 weeks after trial completion. The primary outcome is the change in the 17-item Hamilton Depression Rating Scale (HAMD-17) score after 20 sessions. Secondary outcomes were defined as changes in other measurement scales, cognitive function, resting-state functional magnetic resonance imaging (rs-fMRI), and serum biomarkers.DiscussionWe hypothesize that, in contrast to the sham group, both the active DLPFC and OFC tDCS groups will show superiority in HAMD-17 score reduction after 5, 10, and 20 sessions. Moreover, associations of the improvement of depressive symptoms with variations in rs-fMRI and TRD-related biomarkers will be evaluated. Our study may suggest that adjunctive intensive tDCS with left DLPFC positive stimulation or right OFC negative stimulation may be effective as a novel method to relieve depressive symptoms in patients with TRD. The variation of rs-fMRI, biomarkers could be used as a potential prediction model of treatment efficacy in TRD.Trial registrationThe trial protocol is registered with www.chictr.org.cn under protocol registration number ChiCTR2200058030. Date of registration: March 27, 2022. Recruitment started in September 2022 and is ongoing.

Sleep patterns correlates with the efficacy of tDCS on post-stroke patients with prolonged disorders of consciousness

BackgroundThe subclassification of prolonged disorders of consciousness (DoC) based on sleep patterns is important for the evaluation and treatment of the disease. This study evaluates the correlation between polysomnographic patterns and the efficacy of transcranial direct current stimulation (tDCS) in patients with prolonged DoC due to stroke.MethodsIn total, 33 patients in the vegetative state (VS) with sleep cycles or without sleep cycles were randomly assigned to either active or sham tDCS groups. Polysomnography was used to monitor sleep changes before and after intervention. Additionally, clinical scale scores and electroencephalogram (EEG) analysis were performed before and after intervention to evaluate the efficacy of tDCS on the patients subclassified according to their sleep patterns.ResultsThe results suggest that tDCS improved the sleep structure, significantly prolonged total sleep time (TST) (95%CI: 14.387–283.527, P = 0.013) and NREM sleep stage 2 (95%CI: 3.157–246.165, P = 0.040) of the VS patients with sleep cycles. It also significantly enhanced brain function of patients with sleep cycles, which were reflected by the increased clinical scores (95%CI: 0.340–3.440, P < 0.001), the EEG powers and functional connectivity in the brain and the 6-month prognosis. Moreover, the changes in NREM sleep stage 2 had a significant positive correlation with each index of the β band.ConclusionThis study reveals the importance of sleep patterns in the prognosis and treatment of prolonged DoC and provides new evidence for the efficacy of tDCS in post-stroke patients with VS patients subclassified by sleep pattern.Trial registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT03809936. Registered 18 January 2019

Effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: study protocol for the pilot of a randomized controlled trial

BackgroundTranscranial direct current stimulation (tDCS) is a technique that can noninvasively modulate neural states in a targeted brain region. As cerebellar activity levels are associated with upper limb motor improvement after stroke, the cerebellum is a plausible target of tDCS. However, the effect of tDCS remains unclear. Here, we designed a pilot study to assess: (1) the feasibility of a study that aims to examine the effects of cerebellar tDCS combined with an intensive rehabilitation approach based on the concept of constraint-induced movement therapy (CIMT) and (2) the preliminary outcome of the combined approach on upper limb motor function in patients with stroke in the chronic stage.MethodsThis pilot study has a double-blind randomized controlled design. Twenty-four chronic stroke patients with mild to moderate levels of upper limb motor impairment will be randomly assigned to an active or sham tDCS group. The participants will receive 20 min of active or sham tDCS to the contralesional cerebellum at the commencement of 4 h of daily intensive training, repeatedly for 5 days per week for 2 weeks. The primary outcomes are recruitment, enrollment, protocol adherence, and retention rates and measures to evaluate the feasibility of the study. The secondary outcome is upper limb motor function which will be evaluated using the Action Research Arm Test, Fugl-Meyer Assessment, for the upper extremity and the Motor Activity Log. Additionally, neurophysiological and neuroanatomical assessments of the cerebellum will be performed using transcranial magnetic stimulation and magnetic resonance imaging. These assessments will be conducted before, at the middle, and after the 2-week intervention, and finally, 1 month after the intervention. Any adverse events that occur during the study will be recorded.DiscussionCerebellar tDCS combined with intensive upper limb training may increase the gains of motor improvement when compared to the sham condition. The present study should provide valuable evidence regarding the feasibility of the design and the efficacy of cerebellar tDCS for upper limb motor function in patients with stroke before a future large trial is conducted.Trial registrationThis study has been registered at the Japan Registry of Clinical Trials (jRCTs042200078). Registered 17 December 2020