Efficacy Of Transcranial Direct Current Stimulation Research Articles

Patient-tailored transcranial direct current stimulation to improve stroke rehabilitation: study protocol of a randomized sham-controlled trial

BackgroundMany patients do not fully regain motor function after ischemic stroke. Transcranial direct current stimulation (TDCS) targeting the motor cortex may improve motor outcome as an add-on intervention to physical rehabilitation. However, beneficial effects on motor function vary largely among patients within and across TDCS trials. In addition to a large heterogeneity of study designs, this variability may be caused by the fact that TDCS was given as a one-size-fits-all protocol without accounting for anatomical differences between subjects. The efficacy and consistency of TDCS might be improved by a patient-tailored design that ensures precise targeting of a physiologically relevant area with an appropriate current strength.MethodsIn a randomized, double-blinded, sham-controlled trial, patients with subacute ischemic stroke and residual upper-extremity paresis will receive two times 20 min of focal TDCS of ipsilesional primary motor hand area (M1-HAND) during supervised rehabilitation training three times weekly for 4 weeks. Anticipated 60 patients will be randomly assigned to active or sham TDCS of ipsilesional M1-HAND, using a central anode and four equidistant cathodes. The placement of the electrode grid on the scalp and current strength at each cathode will be personalized based on individual electrical field models to induce an electrical current of 0.2 V/m in the cortical target region resulting in current strengths between 1 and 4 mA. Primary endpoint will be the difference in change of Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score between active TDCS and sham at the end of the intervention. Exploratory endpoints will include UE-FMA at 12 weeks. Effects of TDCS on motor network connectivity and interhemispheric inhibition will be assessed with functional MRI and transcranial magnetic stimulation.DiscussionThe study will show the feasibility and test the efficacy of personalized, multi-electrode anodal TDCS of M1-HAND in patients with subacute stroke patients with upper-extremity paresis. Concurrent multimodal brain mapping will shed light into the mechanisms of action of therapeutic personalized TDCS of M1-HAND. Together, the results from this trial may inform future personalized TDCS studies in patients with focal neurological deficits after stroke.

Therapeutical impacts of transcranial direct current stimulation on drug-resistant epilepsy in pediatric patients: A double-blind parallel-group randomized clinical trial

BackgroundDrug-resistant epilepsy is a challenging problem in pediatrics. Transcranial direct current stimulation (TDCS) is a non-invasive neurostimulation technique suggested as a promising method for treating epilepsy. This study aims to evaluate the efficacy of TDCS in focal epilepsy in children with drug-resistant epilepsy. MethodWe conducted a randomized sham-controlled study with 18 subjects between 6 and 16 years of age, divided equally into two groups. TDCS was performed in 20-minute daily stimulation protocol for five days for both groups. The current intensity was one mA for the first three days, increasing to 1.5 mA on day four and 2 mA on the last day of stimulation. EEG was done before and after the intervention. ResultsThere was a significant reduction in seizure duration in the case group compared with the sham group. Conclusionfive consecutive days of performing TDCS significantly reduced seizure duration in children with focal Drug-resistant epilepsy. However,further studies in this field are necessary to test the effectiveness and set up a coherent and comprehensive protocol.

Efficacy of Transcranial Direct-Current Stimulation in Catatonia: A Review and Case Series.

Catatonia is a severe neuropsychiatric syndrome, usually treated by benzodiazepines and electroconvulsive therapy. However, therapeutic alternatives are limited, which is particularly critical in situations of treatment resistance or when electroconvulsive therapy is not available. Transcranial direct-current stimulation (tDCS) is a promising non-invasive neuromodulatory technique that has shown efficacy in other psychiatric conditions. We present the largest case series of tDCS use in catatonia, consisting of eight patients in whom tDCS targeting the left dorsolateral prefrontal cortex and temporoparietal junction was employed. We used a General Linear Mixed Model to isolate the effect of tDCS from other confounding factors such as time (spontaneous evolution) or co-prescriptions. The results indicate that tDCS, in addition to symptomatic pharmacotherapies such as lorazepam, seems to effectively reduce catatonic symptoms. These results corroborate a synthesis of five previous case reports of catatonia treated by tDCS in the literature. However, the specific efficacy of tDCS in catatonia remains to be demonstrated in a randomized controlled trial. The development of therapeutic alternatives in catatonia is of paramount importance.

Effects of transcranial direct current stimulation on patients with post-stroke fatigue: a study protocol for a double-blind randomized controlled trial

IntroductionPost-stroke fatigue (PSF) is an abnormal, persistent, and unexplained physical and psychological tiredness in patients after stroke. It is a common symptom of stroke patients with poor quality of life and bleak prognosis, and the incidence rate is up to 39% to 72%. It has been widely reported that medicine treatments achieved a lot of progress, there still needs to develop more powerful new strategies to more powerful effect. The transcranial direct-current stimulation (tDCS) shows great potential for the treatment of PSF. This study proposes to apply a double-blind randomized controlled clinical trial to explore the effect and safety of tDCS combined with routine rehabilitation for PSF.Methods and analysisOne hundred patients with PSF will be randomly divided into two groups. One of the groups will receive conventional rehabilitation therapy and active tDCS, whereas another group will receive conventional rehabilitation treatment and sham tDCS. Both groups will receive the intervention for 4 weeks, during which time they will undergo either active or sham tDCS 20 min a day, 6 days a week. Primary outcome: Fatigue Severity Scale (FSS) will be measured at baseline every weekend during the intervention period. Secondary results: Fatigue Impact Scale (FIS), Functional Assessment Chronic Illness Therapy (Fatigue) (FACIT-F), and Specialized Quality of Life Scale in Stroke (SS-QOL) will be measured at baseline and at the end of the intervention time of 4 weeks. Throughout the study, adverse events and adverse reactions will be measured during every treatment. The research study “Effects of transcranial direct current stimulation on patients with post-stroke fatigue” has been approved by the Ethics Committee of the First Affiliated Hospital of Nanchang University: Clinical Medicine Ethics Review [2015]043 in Nov 2015.DiscussionThis study will provide insight into the efficacy of transcranial direct-current stimulation for post-stroke fatigue. This is a double-blind randomized controlled trial whose aim is to assess the effects of tDCS on PSF. This study can provide more information about the treatment of PSF. This study has a period of follow-up, which allows for greater accuracy. It is a single-center trial, and this may be a limitation. The other limitation of this study is the relatively small number of participants; thus, the influence of chance on experimental results cannot be completely ruled out.Trial registrationChinese Clinical Trial Registry ChiCTR2000031120. Registered on March 22, 2020. This protocol version number is V1.1.

Efficacy of transcranial direct-current stimulation on chronic insomnia

The purpose of this study was to assess the effect and safety of transcranial direct current stimulation (tDCS) in primary chronic insomnia. A one-month, double-blind, randomized, sham-controlled trial was performed. A total of 7 patients with primary chronic insomnia received tDCS using anodal (n=3), cathodal (n=2) or sham stimulation (n=2). They were followed up at 1 week and 1 month after treatment. The primary outcome measures included improvement in total sleep time (TST), sleep latency (SL), and sleep efficiency (SE) at 1-month follow-up. TST and SE were improved with tDCS at 1-month follow-up in all patients (100 %) of the anodal group, one (50 %) of the cathodal group, and one (50 %) of the sham group. tDCS improved SL at 1-month follow-up in two patients (67%) of the anodal group, one (50%) of the cathodal group, and none (0%) of the sham group. With respect to adverse events, transient itching sensation occurred in one patient of the anodal group. None of the other groups reported adverse events. Our results suggest that tDCS may be effective and safe for treatment of primary chronic insomnia. A larger controlled study needs to be further investigated.

Efficacy of Transcranial Direct Current Stimulation in the Treatment: Resistant Patients who Suffer from Severe Obsessive-compulsive Disorder.

Background:During the past years, significant efforts have been made to explain the biological backgrounds of obsessive-compulsive disorder (OCD). Cortical-subcortical and neurotransmitter models are used for explaining the symptoms of OCD, so our hypothesis is that brain's transcranial direct current stimulation (TDCS) can regulate the brain activities of the OCD patients. Thus, based on the mentioned issues, this research seeks to investigate the efficacy of TDCS in treatment-resistant patients who suffer from severe OCD.Materials and Methods:The present study is a clinical trial research which was based on the available sampling method, 42 treatment-resistant patients who suffer from severe OCD were selected as research's samples (2015–2016). Medical intervention protocol in this study is TDCS cathode type that was done in 15 sessions for 3 consecutive weeks (each session was conducted for 30 min daily). Yale–Brown Obsessive-Compulsive Scale was used for evaluating the efficacy of TDCS method during the 1st, 5th, 10th, and 15th sessions and it was also used for checking the 1st and 3rd monthly follow-up phases.Results:Variance within-group analysis (repeated measure) showed that the mean differences in the different stages of evaluation are significant (seven stages of evaluation).Conclusion:TDCS can be introduced as an appropriate, strong tool for regulating the brain - behavioral systems and it can also be introduced as a suitable alternative treatment for treatment-resistant patients who suffer from severe OCD.

Efficacy of Transcranial Direct-Current Stimulation in Women With Provoked Vestibulodynia

(Abstracted from Am J Obstet Gynecol 2017;216(6):584.e1–584.e11) The most frequent cause of premenopausal dyspareunia is provoked vestibulodynia (PVD). Patients with PVD have acute recurrent pain at the vaginal entrance in response to attempted vaginal penetration or application of pressure.

Efficacy of transcranial direct-current stimulation in women with provoked vestibulodynia

Provoked vestibulodynia is a highly prevalent condition characterized by acute recurrent pain located at the vaginal entrance in response to pressure application or attempted vaginal penetration. Despite a wide variety of treatments offered to women with provoked vestibulodynia, a high proportion of women are refractory to conventional treatment. Transcranial direct-current stimulation is a noninvasive brain stimulation technique that has been shown effective for improving various chronic pain conditions. Growing evidence suggests that the central nervous system could play a key role in provoked vestibulodynia. Targeting the central nervous system could therefore be a promising treatment for women with provoked vestibulodynia. The purpose of this study was to evaluate and compare the efficacy of active and sham transcranial direct-current stimulation in reducing pain intensity during intercourse in patients with provoked vestibulodynia. We conducted a triple-blind, parallel-group, randomized controlled trial. Women aged 17-45 years diagnosed with provoked vestibulodynia by a gynecologist using a validated protocol were randomized to 10sessions of either active transcranial direct-current stimulation (intensity= 2 mA) or 10 sessions of sham transcranial direct-current stimulation, over a 2-week period. Both active and sham transcranial direct-current stimulation were applied for 20 minutes, with the anode positioned over the primary motor cortex, and the cathode over the contralateral supraorbital area. Outcome measures were collected at baseline, 2 weeks after treatment, and at 3-month follow-up by an evaluator blinded to group assignment. The primary objective was to assess pain intensity during intercourse, using a numerical rating scale. Secondary outcomes focused on sexual function and distress, vestibular sensitivity, psychological distress, treatment satisfaction, and patient impression of change. Statistical analyses were conducted on the intention-to-treat basis, and treatment effects were evaluated using a mixed linear model for repeated measures. A total of 40 patients were randomly assigned to receive either active (n= 20) or sham (n= 20) transcranial direct-current stimulation treatments from November 2014 through February 2016. Baseline characteristics were similar between the active and sham transcranial direct-current stimulation groups. In full compliance with the study protocol, every participant followed all courses of the study treatment, including assessments at 2-week and 3-month follow-up. Pain during sexual intercourse was not significantly different between active and sham treatment groups 2 weeks after treatment (P= .84) and at follow-up (P= .09). Mean baseline and 2-week assessment pain intensity were, respectively, 6.8 (95% confidence interval, 5.9-7.7) and 5.6 (95% confidence interval, 4.7-6.5) for active transcranial direct-current stimulation (P= .03) vs 7.5 (95% confidence interval, 6.6-8.4) and 5.7 (95% confidence interval, 4.8-6.6) for sham transcranial direct-current stimulation (P= .001). Nonsignificant differences between the 2 groups were also found in their sexual function and distress after treatment (P > .20) and at follow-up (P > .10). Overall, at 2-week assessment 68% assigned to active transcranial direct-current stimulation reported being very much, much, or slightly improved compared to 65% assigned to sham transcranial direct-current stimulation (P= .82), and still comparable at follow-up: 42% vs 65%, respectively (P= .15). Findings suggest that active transcranial direct-current stimulation is not more effective than sham transcranial direct-current stimulation for reducing pain in women with provoked vestibulodynia. Likewise, no significant effects were found on sexual function, vestibular sensitivity, or psychological distress.

Efficacy of transcranial direct-current stimulation (tDCS) in women with provoked vestibulodynia: study protocol for a randomized controlled trial.

BackgroundProvoked vestibulodynia is the most common form of vulvodynia. Despite its high prevalence and deleterious sexual, conjugal, and psychological repercussions, effective evidence-based interventions for provoked vestibulodynia remain limited. For a high proportion of women, significant pain persists despite the currently available treatments. Growing evidence suggests that the central nervous system (CNS) could play a key role in provoked vestibulodynia; thus, treatment targeting the CNS, rather than localized dysfunctions, may be beneficial for women suffering from provoked vestibulodynia. In this study, we aim to build on the promising results of a previous case report and evaluate whether transcranial direct-current stimulation, a non-invasive brain stimulation technique targeting the CNS, could be an effective treatment option for women with provoked vestibulodynia.Methods/designThis single-center, triple-blind, parallel group, randomized, controlled trial aims to compare the efficacy of transcranial direct-current stimulation with sham transcranial direct-current stimulation in women with provoked vestibulodynia. Forty women diagnosed with provoked vestibulodynia by a gynecologist, following a standardized treatment protocol, are randomized to either active transcranial direct-current stimulation treatment for ten sessions of 20 minutes at an intensity of 2 mA or sham transcranial direct-current stimulation over a 2-week period. Outcome measures are collected at baseline, 2 weeks after treatment and at 3-month follow-up. The primary outcome is pain during intercourse, assessed with a numerical rating scale. Secondary measurements focus on the sexual function, vestibular pain sensitivity, psychological distress, treatment satisfaction, and the patient’s global impression of change.DiscussionTo our knowledge, this study is the first randomized controlled trial to examine the efficacy of transcranial direct-current stimulation in women with provoked vestibulodynia. Findings from this trial are expected to provide significant information about a promising intervention targeting the centralization of pain in women with provoked vestibulodynia.Trial registrationClinicaltrials.gov, NCT02543593. Registered on September 4, 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1366-5) contains supplementary material, which is available to authorized users.

P 128. Predicting behavioural response to TDCS in chronic motor stroke

Transcranial direct current stimulation (TDCS) of primary motor cortex (M1) can transiently improve paretic hand function in chronic stroke. However, responses are variable so there is incentive to try to improve efficacy or to predict response in individual patients. Both excitatory (Anodal) stimulation of ipsilesional M1 and inhibitory (Cathodal) stimulation of contralesional M1 can speed simple reaction time. Here we tested whether combining these two effects simultaneously, by using a bilateral M1–M1 electrode montage, would improve efficacy. We tested the physiological efficacy of Bilateral, Anodal or Cathodal TDCS in changing motor evoked potentials (MEPs) in the healthy brain and their behavioural efficacy in changing reaction times with the paretic hand in chronic stroke. In addition, we aimed to identify clinical or neurochemical predictors of patients’ behavioural response to TDCS. There were three main findings: (1) Unlike Anodal and Cathodal TDCS, Bilateral M1–M1 TDCS (1 mA, 20 min) had no significant effect on MEPs in the healthy brain or on reaction time with the paretic hand in chronic stroke patients; (2) GABA levels in ipsilesional M1 predicted patients’ behavioural gains from Anodal TDCS; (3) Although patients were in the chronic phase, time since stroke (and its combination with Fugl-Meyer score) was a positive predictor of behavioural gain from Cathodal TDCS. These findings indicate the superiority of Anodal or Cathodal over Bilateral TDCS in changing motor corticospinal excitability in the healthy brain and in speeding reaction time in chronic stroke. The identified clinical and neurochemical markers of behavioural response should help to inform the optimization of TDCS delivery and to predict patient outcome variability in future TDCS intervention studies in chronic motor stroke.

Predicting behavioural response to TDCS in chronic motor stroke

Transcranial direct current stimulation (TDCS) of primary motor cortex (M1) can transiently improve paretic hand function in chronic stroke. However, responses are variable so there is incentive to try to improve efficacy and or to predict response in individual patients. Both excitatory (Anodal) stimulation of ipsilesional M1 and inhibitory (Cathodal) stimulation of contralesional M1 can speed simple reaction time. Here we tested whether combining these two effects simultaneously, by using a bilateral M1–M1 electrode montage, would improve efficacy. We tested the physiological efficacy of Bilateral, Anodal or Cathodal TDCS in changing motor evoked potentials (MEPs) in the healthy brain and their behavioural efficacy in changing reaction times with the paretic hand in chronic stroke. In addition, we aimed to identify clinical or neurochemical predictors of patients' behavioural response to TDCS. There were three main findings: 1) unlike Anodal and Cathodal TDCS, Bilateral M1–M1 TDCS (1mA, 20min) had no significant effect on MEPs in the healthy brain or on reaction time with the paretic hand in chronic stroke patients; 2) GABA levels in ipsilesional M1 predicted patients' behavioural gains from Anodal TDCS; and 3) although patients were in the chronic phase, time since stroke (and its combination with Fugl–Meyer score) was a positive predictor of behavioural gain from Cathodal TDCS. These findings indicate the superiority of Anodal or Cathodal over Bilateral TDCS in changing motor cortico-spinal excitability in the healthy brain and in speeding reaction time in chronic stroke. The identified clinical and neurochemical markers of behavioural response should help to inform the optimization of TDCS delivery and to predict patient outcome variability in future TDCS intervention studies in chronic motor stroke.

Transcranial direct current stimulation of the affected hemisphere does not accelerate recovery of acute stroke patients

Transcranial direct current stimulation (TDCS) is a potential tool to improve motor deficits in chronic stroke patients. Safety and efficacy of this procedure in acute stroke patients have not yet been addressed. We performed in our stroke unit a single-centre randomized, double-blind, sham-controlled study to investigate safety and efficacy of anodal TDCS of the affected hemisphere in acute stroke patients. The second day from stroke onset, 50 acute stroke patients received either five-daily sessions of anodal (n=25) at 2mA for 20min or sham TDCS (n=25) to the ipsilesional primary motor cortex (M1). Motor deficit was assessed by the short form of the Fugl-Meyer motor scale (FM) and overall neurological deficit by the National Institute of Health Stroke Scale (NIHSS) at onset, at 5days after stroke and after 3months. No side effects were detected during either TDCS or sham. In both groups, there was a significant improvement in NIHSS and FM scores, which did not significantly differ when comparing TDCS and sham. Five-daily sessions of anodal TDCS to the ipsilesional M1 appear to be safe in acute stroke patients but do not improve clinical outcome.