Continuous Intrathecal Baclofen Research Articles

Safety and efficacy of continuous intrathecal baclofen via cervical catheter tip: a retrospective case series.

Intrathecal baclofen (ITB) is an effective treatment for hypertonia in children involving the implantation of a pump and catheter system. The highest concentration of ITB is at the catheter tip. The catheter tip location is most commonly within the lumbar or thoracic spine. The cervical tip location has traditionally been avoided because of concerns of hypoventilation and pneumonia; however, these complications in cervical compared with thoracic or lumbar placement have not been reliably proven. Some studies have suggested that cervical ITB location better treats upper-extremity hypertonia. There are limited data describing the safety and efficacy of cervical ITB on hypertonia. The authors present a single-institution retrospective case series highlighting the safety and efficacy of using cervical ITB location for the treatment of hypertonia. Retrospective data analysis was performed for children who underwent continuous dosing cervical ITB between April 2022 and October 2023. Nonmodifiable risk factors, clinical variables, operative characteristics, and adverse outcomes were collected. This study included 25 patients (8 female). The mean age at implantation was 12.4 years, and the mean operative duration was 90 minutes. The mean Barry-Albright Dystonia Scale score decreased by 9.5 points (p = 0.01). The mean aggregated modified Ashworth scale score in the upper extremities decreased by 2.14 points (p = 0.04), and that in the lower extremities decreased by 4.98 points (p < 0.01). One patient each (4%) had infection and baclofen toxicity. Two patients (8%) had respiratory depression requiring continuous positive airway pressure. There was no incidence of pneumonia or wound dehiscence. The cervical catheter tip location for ITB is safe, is effective to control tone, and should be considered for the treatment of hypertonia. Larger studies with longer follow-up are necessary to further determine upper-limit dosing safety along with long-term functional benefits in these patients.

Long-term use of intrathecal baclofen reduces neuropathic pain and its interference with general activity in spinal cord injury individuals.

Long-term analgesic effect of intrathecal baclofen was reported in individuals with spinal cord injury. We conducted a prospective study to evaluate the effect of intrathecal baclofen on subtypes of neuropathic pain and its interference with general activity. Nine spinal cord injury individuals who presented with severe spasticity and moderate to severe neuropathic pain received intrathecal baclofen via an implanted pump. We applied the ASIA Impairment Scale to assess spinal cord injury severity. Neuropathic pain was evaluated by numerical rating scale, Neuropathic Pain Symptom Inventory, and Brief Pain Inventory. Evaluations were performed at baseline and after at least 6months of continuous intrathecal baclofen treatment. Intrathecal baclofen led to significant pain reduction as measured by numerical rating scale, Neuropathic Pain Symptom Inventory, and Brief Pain Inventory (p < 0.05). Improvements were significant for paroxysmal pain and dysesthesia and for pain interference with general activity, as assessed by the Brief Pain Inventory (p < 0.05). There was a significant relationship between the time since spinal cord injury and changes in paroxysmal pain as well as in the total Neuropathic Pain Symptom Inventory score (p < 0.05). The baclofen dose correlated also to the percentage changes in neuropathic pain improvement and sleep (p < 0.003). The present results provide evidence that intrathecal baclofen effectively reduces neuropathic pain, particularly paroxysmal pain and dysesthesia, and improves pain interference and overall well-being in individuals with spinal cord injury. Clinicians should be aware of this less well-known beneficial effect of intrathecal baclofen and should consider such a treatment option for better control of neuropathic pain in individuals with spinal cord injury.

Clinical course of pain intensity in individuals with cerebral palsy: A prognostic systematic review.

To describe the clinical course of pain intensity in individuals with cerebral palsy (CP) resulting from usual care or specific interventions. We conducted an exploratory prognostic systematic review searching electronic databases from inception to 31st December 2021. Evidence from low and moderate risk-of-bias studies was synthesized. We retrieved 2275 citations; 18 studies met the inclusion criteria and 10 were synthesized. The course of pain intensity in children with CP receiving usual care was stable over 15 weeks (χ2 [2] =1.8, p=0.5). Children who received continuous intrathecal baclofen (CITB) reported significant pain intensity reduction (visual analogue scale [VAS]=-4.2 out of 10, 95% confidence interval [CI]=-6.3 to -2.1]) 6 months postinsertion but similar children receiving usual care had no significant change over 6 months (VAS=1.3 out of 10, 95% CI=-1.3 to 3.6). Children receiving botulinum neurotoxin A (BoNT-A) injections had significant decreases in pain after 1 month (numeric rating scale=-6.5, 95% CI=-8.0 to -5.0). Adults with chronic pain receiving usual care reported stable pain intensity over time; pain intensity improved in ambulatory adults exercising and those treated surgically for cervical myelopathy. The course of pain intensity in individuals with CP is unclear. Evidence suggests that children and adults receiving usual care had stable pain intensity over the short or long term. Interventions (CITB and BoNT-A in children and exercise and surgical treatment for cervical myelopathy in adults) had pain intensity reduction. Larger study samples are needed to confirm these results. Pain intensity was stable in children with cerebral palsy (CP) receiving usual care. Adults with CP and chronic pain receiving usual care had stable, persistent pain intensity. Children receiving continuous intrathecal baclofen via pump and botulinum neurotoxin A reported significantly lower pain intensities. Adults with chronic pain and dyskinetic CP and cervical myelopathy reported significantly lower pain intensity with exercise or cervical decompression. Limited high-quality evidence exists describing non-procedural pain changes in individuals with CP.

Intrathecal baclofen pump replacements under local anaesthetic: rapid pathway implementation under COVID-19

Intrathecal baclofen pump replacements under local anaesthetic: rapid pathway implementation under COVID-19

Spasticity with tethered cord syndrome treated with continuous intrathecal baclofen: a case report

Spasticity with tethered cord syndrome treated with continuous intrathecal baclofen: a case report

Protocolo diagnóstico y terapéutico de la espasticidad

Spasticity is a motor disorder caused by several conditions of the nervous central system (cerebral or spinal cord origin) (NCS). Symptomatology encompass contractures, pain, stiffness and, in general, deterioration of neurological status. In patients with spasticity after spinal cord injury, removing all aggravating factors and stablishing a physical rehabilitation treatments to reduce spastic component are mandatory. Treatment schedule is as follows: prevention of complications that may worse spascticity, physical rehabilitation, orthosis, oral pharmacologic interventions, botulinum toxin injection for focal spasticity and continuous intrathecal baclofen infusion

Intrathecal Baclofen Trial Before Device Implantation: 12-Year Experience With Continuous Administration

ObjectiveTo report our experience using continuous intrathecal baclofen (ITB) administration prior to a possible ITB device implantation. DesignRetrospective open label study. Mean duration of follow-up 64 months. SettingPrimary-care and referral center, ambulatory and hospitalized care. ParticipantsPatients (N=116) undergoing continuous ITB trials between 2006 and 2017. InterventionsContinuous application of baclofen via a temporary intrathecal catheter connected to an external pump. Main Outcome MeasuresAssessment of the modified Ashworth Scale and range of movement prior versus end of ITB trial. According to the Barthel Index, definition of high-level patients (60-100 scoring points) and low-level patients (0-55 scoring points). Calculation of the Rivermead Mobility Index in high-level patients prior versus end of ITB trial. Evaluation of occurring adverse events. ResultsA total of 119 ITB trials were performed in 116 patients (78 men, mean age 41±16), 113 patients completed the trials (31 of 113 high level, 82 of 113 low level). The median modified Ashworth scale improved from 4 (interquartile range [IQR] 3-4) to 2 (IQR 1-2; P≤.001), the range of movement from 2 (IQR 1-3) to 3 (IQR 3-3; P≤.001). The Rivermead Mobility Index increased from 9 (IQR 6-12) to 10 (IQR 7-12.5; P=.004) in high-level patients. Eighty-eight out of 113 patients (78%) were appropriate candidates for ITB device surgery, 75 of 88 (85%) proceeded to an implantation. A total of 69 adverse events occurred in 57 of 119 trials (48%), 37 of 69 (54%) were drug related, 32 of 69 (46%) were procedure related, and 42 of 69 (61%) were minor. The ITB device was implanted in 69 of 75 patients (92%) at last follow-up. ConclusionsContinuous administration of ITB is an effective and useful alternative to ITB bolus application during ITB screening period. Half of the patients experienced adverse events; the majority were minor events.

Effect of continuous intrathecal baclofen therapy in children: a systematic review

AimTo investigate the effects of continuous intrathecal baclofen (ITB) therapy in children with cerebral palsy (CP) and other neurological conditions.MethodThis systematic review was conducted using standardized methodology, searching four electronic databases (PubMed, Embase, CINAHL, Cochrane Library) for relevant literature published between inception and September 2017. Included studies involved continuous ITB as an intervention and outcome measures relating to all International Classification of Functioning, Disability and Health: Children and Youth (ICF‐CY) components.ResultsThirty‐three studies were identified, of which one, including 17 children with spastic CP, produced level II evidence, and the others, mainly non‐controlled cohort studies, level IV and V. Outcomes at body function level were most frequently reported. Results suggest continuous ITB may be effective in reducing spasticity and dystonia in CP, as well as other neurological conditions, and may improve the ease of care and quality of life of children with CP, but the level of evidence is low.InterpretationDespite three decades of applying ITB in children and a relatively large number of studies investigating the treatment effects, a direct link has not yet been demonstrated because of the low scientific quality of the primary studies. Further investigation into the effects of continuous ITB at all levels of the ICF‐CY is warranted. Although large, controlled trials may be difficult to realize, national and international collaborations may provide opportunities. Also, multicentre prospective cohort studies with a long‐term follow‐up, employing harmonized outcome measures, can offer prospects to expand our knowledge of the effects of continuous ITB therapy in children.What this paper adds There is low‐level evidence for continuous intrathecal baclofen (ITB) in children with cerebral palsy.Continuous ITB is effective in reducing spasticity and dystonia in non‐controlled cohort studies.Evaluation of individual goals and systematic assessment of long‐term effects in large cohort studies are required.

Continuous intrathecal baclofen delivery in severely disabling spasticity

Background/Aim. Spasticity is the consequence of several clinical conditions including cerebral palsy, brain injury, spinal cord injury, multiple sclerosis, aneurysm bleeding, and some other neurological disorders. The aim of this study was to determine the efficacy of intrathecal baclofen (ITB) treatment in medically intractable severely disabling spasticity and present the challenges encountered during pump implantation surgery on these patients. Methods. The patients who underwent intrathecal baclofen pump implantation surgery between the years 2012 and 2015 with minimum follow-up of six months were recruited from the clinic archives. Twenty two patients with severe spasticity who had Modified Asworth Spasticity Scale (MASS) score of 3 or 4 were enrolled in our series. Eight of twenty-two patients were at pediatric age and they all were non-ambulant before surgery. Results. All of the patients underwent programmable intrathecal baclofen pump implantation surgery. Catheters were placed via percutaneous technique into to the subarachnoid space in 18 patients while, we had to perform partial hemi-laminectomy in order to place the catheters in 4 patients. All the patients improved significantly and 5 began using upper extremities and 3 adults became ambulant following physical therapy. Mean of the MASS scores improved from 3.59 to 1.32 (p &lt; 0.001). Conclusion. The ITB therapy obviously increased quality of life and functional outcome in patients with disabling spasticity. As a result, physical treatment was more useful for these patients. Although some spinal abnormalities due to spasticity may necessitate partial hemilaminectomy to implant the pump, patients with intractable spasticity should be given the chance of intrathecal baclofen treatment at the earliest period of their lifetime disability.

Percutaneous Endoscopic Gastrostomy in a Patient With Continuous Intrathecal Baclofen Infusion Therapy

Percutaneous endoscopic gastrostomy (PEG) is the method of choice in patients requiring long-term enteral tube feeding. In patients with intrathecal baclofen infusion therapy (IBT) pump implantation, infection via the skin and soft tissue may be an issue of concern. The introducer technique for gastrostomy tube insertion may be useful in reducing the risk of peristomal infection. Although the presence of a PEG tube has been reported as a risk factor for implantation site infection (for newly inserted IBT pumps), whether existing IBT pumps are at risk for infection during or after the placement of a PEG tube is not clear. We report a case where PEG was successfully performed using the introducer technique on a patient with an IBT pump implant.

Poster 291 Improved Upper Extremity Spasticity During Continuous Intrathecal Baclofen Trial with High Cervical Catheter Placement: A Case Report

Poster 291 Improved Upper Extremity Spasticity During Continuous Intrathecal Baclofen Trial with High Cervical Catheter Placement: A Case Report

Treatment of severe, disabling spasticity with continuous intrathecal baclofen therapy following acquired brain injury: the experience of a tertiary institution in Singapore.

Intrathecal baclofen (ITB) therapy is a proven, effective treatment for disabling cortical spasticity. We describe the first local series of five patients with acquired brain injury (ABI) who received ITB and were followed up for 63.8 months. A retrospective review of medical and rehabilitation records of patients who received ITB therapy was carried out. Data studied included baseline demographic and injury variables, implantation data, spasticity and function, ITB dosage over time and complications. From 2006 to 2010, a total of five patients received ITB therapy via implanted pumps about 39.4 months after ABI. Four out of five patients experienced significant reductions in their lower limb spasticity scores and improvements in global function and dependency. One patient had minor adverse events associated with baclofen-related sedation. The mean ITB dose at one year was 182.7 ± 65.6 mcg/day. Our preliminary study showed encouraging long-term outcomes and safety for ITB therapy after ABI-related intractable spasticity. Individual ITB responses over time were variable, with gender differences. The outcomes experienced by our centre were comparable to those in the general ABI population, supporting the efficacy of ITB therapy for chronic disabling spasticity.

Use of continuous intrathecal baclofen in hereditary spastic paraplegia

Objective: Hereditary spastic paraplegia (HSP) is a rare progressive disorder with few treatment options. We aim to describe the effect of continuous intrathecal baclofen (ITB) pump therapy on the clinical and functional outcomes of patients with HSP. Methods: This is a retrospective study, using medical record audit data. Adult patients with HSP who had received ITB trial or therapy and had pre- and post-ITB assessment data available were eligible for inclusion. A purposefully designed audit tool was used. Patients with a successful trial received an ITB implantable SynchroMed ® II pump. Demographic, clinical, and outcome data were obtained pre- and post-pump trial and pump insertion. Functional, spasticity, and mobility measures were compared pre- and post-ITB trial and pre- and post-ITB pump insertion. Results: Data for nine patients were available. Six were male and the median age was 55 years (Q1, Q3: 46, 55). All received an ITB trial, and those who responded favorably (n=8) had an ITB pump inserted. Following ITB therapy, improvements were demonstrated for rectus femoris (P=0.04) and gastrocnemius spasticity measures (P=0.03). All patients reported subjective improvements in function, and three of the four with pre- and post-pump assessments, demonstrated clinically meaningful improvements in mobility. Side effects were minimized with appropriate dose titrations. Conclusion: This is the largest retrospective patient study in the field. The potential benefits of ITB in selected patients with HSP were demonstrated.

Effect of continuous intrathecal baclofen therapy on ambulatory children with cerebral palsy

Effect of continuous intrathecal baclofen therapy on ambulatory children with cerebral palsy

Clinical Experience With Continuous Intrathecal Baclofen Trials Prior to Pump Implantation

ObjectiveTo report our clinical experience using continuous intrathecal baclofen (ITB) trials prior to permanent pump implantation. DesignRetrospective chart review. SettingAn inpatient neurosurgery unit and outpatient physical medicine and rehabilitation clinics. ParticipantsFifty-seven patients with refractory spasticity who underwent a continuous ITB trial during the years 2006-2012. MethodsPatients underwent placement of a temporary intrathecal catheter that was connected to an external pump. A successful trial was defined as a one-level reduction in lower limb modified Ashworth scores in key spastic lower limb muscles identified for each individual patient. Subjective improvement in function or ease of performing functional tasks also were monitored. Main Outcome MeasuresModified Ashworth scores, functional mobility in ambulatory patients only, and the incidence and severity of adverse events during the trial and up to 1 year after implantation. ResultsSpasticity significantly decreased during the trial. Average ambulation distance was unchanged, although 34% of ambulatory patients progressed to a less restrictive assistive device by trial completion. Adverse events (AEs) occurred in 26 patients. Minor AEs were seen in 18 patients, with the most common being nausea, transient urinary retention, and headache. Pumps were implanted in 86% of patients; 14% did not receive a pump because of AEs or because goals were not met. Six patients had their pump removed at 12 months for the following reasons: pump malfunctions (3), skin breakdown around the pump (1), infection (1), and expectations not met (1). ConclusionsContinuous trials via an external catheter could be an option if patients and clinicians desire a comprehensive assessment of systemic and functional effects of ITB before pump implantation. The majority of AEs were minor and resolved spontaneously, and the most effective starting intrathecal dose was determined by pump insertion.

5. Neurophysiological assessment of spasticity in multiple sclerosis

Objective Spasticity is a frequent and often disabling feature of multiple sclerosis (MS). Up to 80–85% of MS cases suffer from different levels of spasticity. Appropriate management of spasticity is therefore an important part of the patient’s care. Muscle hypertonia is generally easy to recognize clinically, quantifying it is quite a complex matter. Correlation between the clinical and neurophysiological measures makes it especially difficult. The aim of the study is to review the main methods of evaluating spasticity published in the scientific literature with stress on our own experience. Methods In this session we will present neurophysiological tests used in assessment of spasticity with a special stress on the comparison of commonly used Modified Ashworth Scales scores (MAS), H-reflex testing, cutaneous and cortical silent periods, and brainstem reflexes. The main treatment options of pharmacological and non-pharmacological approaches will be discussed. Results Oral antispastic medication, therapeutic exercise and physical modalities are commonly used. From a pharmacological perspective of spasticity treatment, it is strongly recommended to use local chemodenervation with botulinum toxin for intramuscular administration under the EMG guidance. A modern approach to treat generalised spasticity is a continuous intrathecal baclofen (ITB) administration directly into the cerebrospinal fluid under neurophysiological monitoring. Conclusion Adequate evaluation and management of spasticity requires multidisciplinary approach and the setting of realistic goals that need to be achieved on an individual level, with regard to every single patient’s needs. Different options for spasticity management are available, however, choice of treatment hinges on a combination of the extent of symptoms, patient preference, and availability of services. Supported by Research Project of Charles University PRVOUK P34, Czech Republic.

21. Longitudinal fMRI assessment in chronic spinal cord injury treated by intrathecal baclofen – Pilot data

Introduction Spasticity is a frequent disabling sign of upper motor neuron lesion in chronic spinal cord injury (SCI). In severe cases intrathecal baclofen (ITB) is recommended as a choice of effective treatment. Baclofen, being as a strong GABAB agonist, modulates cortical and spinal inhibitory circuits. The aim of this study was to assess longitudinal changes in brain activation after continuous ITB delivery during simple motor tasks performed by functional magnetic resonance imaging (fMRI). Material and Methods Two subjects (27 and 35 years-old males, 5.5 years after SCI) with chronic posttraumatic cervical spinal cord injury at C4–5 level underwent ITB pump implantation (Synchromed II, 20 ml, Medtronic). Spasticity was assessed by Modified Ashworth Scale (MAS, 0–4). Both subjects were studied by 1.5T fMRI with three tasks employed: (i) finger-tapping and mental movement simulating, (ii) finger taping and (iii) foot flexion. Tasks were performed before, 12 weeks and one year after ITB pump implantation. Analysis was processed in SPM8 using the FWE corrected threshold (p Results Both patients were classified as AIS-A and they presented no active movements of lower limbs. In both subjects, MAS score declined in the lower extremities from 4 to 1 before and after ITB implantation, respectively. Before-ITB pump implantation fMRI showed weak activations in all tasks. Post-ITB tasks extensively raised activation in the motor system network, namely the primary sensorimotor cortex and supplementary motor area. In one year follow-up, the activation in foot-flexion mental tasks were detectable only in one of the subjects, with slightly increased volume. One of the most important factors, influencing all the results, is subject motion. Conclusions Continuous ITB administration relieving spasticity in SCI patients was associated with increased activation of sensorimotor cortex. ITB treatment may cause distant functional reorganization of sensorimotor network probably by increased GABAB-mediated inhibitory activity at cortical level. Supported by Research Projects PRVOUK P34, UNCE 204010/2012 and IGA NT12282.

Improved Gait Performance in a Patient With Hereditary Spastic Paraplegia After a Continuous Intrathecal Baclofen Test Infusion and Subsequent Pump Implantation: A Case Report

ObjectiveTo show the benefits of a continuous intrathecal baclofen (ITB) test infusion in a patient with hereditary spastic paraplegia (HSP), with an improved gait performance after ITB pump implantation. DesignCase report. SettingUniversity hospital. ParticipantA 49-year old man with HSP experiencing progressive walking difficulties because of lower extremity spasticity, which did not respond to oral spasmolytics. InterventionsA prolonged, continuous ITB test infusion was started at a low dose and increased gradually, to provide a stable dose of ITB over a prolonged period. The gradual dose increase provided the patient enough time to experience the effects of ITB, because he feared that ITB therapy might cause functional loss. Main Outcome MeasuresModified Ashworth Scale, electromyography, muscle strength, timed Up and Go tests, and the Patient Global Impression of Change. Gait performance before and after ITB pump implantation was assessed in a motion laboratory. ResultsDuring the test infusion, the ITB dose was gradually increased to a continuous dose of 108μg/d. This dose caused the spasticity to decrease, with maintenance of muscle strength. After pump implantation, gait performance was improved, resulting in increased knee flexion during the loading response and a doubled walking speed as compared with baseline. ConclusionsPatients with HSP who have mild spasticity that does not respond to oral spasmolytics should receive a continuous ITB test infusion, to provide them with enough time to experience the delicate balance between spasmolysis and muscle strength. ITB administration is a suitable therapy to improve gait performance in patients with HSP.

Cost Analysis of two Aftercare Strategies in Chronic Continuous Intrathecal Baclofen Therapy in Patients with Intractable Spasticity.

Cost Analysis of two Aftercare Strategies in Chronic Continuous Intrathecal Baclofen Therapy in Patients with Intractable Spasticity.

Intrathecal baclofen treatment in dystonic cerebral palsy: a randomized clinical trial: the IDYS trial

BackgroundDystonic cerebral palsy is primarily caused by damage to the basal ganglia and central cortex. The daily care of these patients can be difficult due to dystonic movements. Intrathecal baclofen treatment is a potential treatment option for dystonia and has become common practice. Despite this widespread adoption, high quality evidence on the effects of intrathecal baclofen treatment on daily activities is lacking and prospective data are needed to judge the usefulness and indications for dystonic cerebral palsy. The primary aim of this study is to provide level one clinical evidence for the effects of intrathecal baclofen treatment on the level of activities and participation in dystonic cerebral palsy patients. Furthermore, we hope to identify clinical characteristics that will predict a beneficial effect of intrathecal baclofen in an individual patient.Methods/DesignA double blind placebo-controlled multi-center randomized clinical trial will be performed in 30 children with dystonic cerebral palsy. Patients aged between 4 and 25 years old with a confirmed diagnosis of dystonic cerebral palsy, Gross Motor Functioning Classification System level IV or V, with lesions in the cerebral white matter, basal ganglia or central cortex and who are eligible for intrathecal baclofen treatment will be included. Group A will receive three months of continuous intrathecal baclofen treatment and group B will receive three months of placebo treatment, both via an implanted pump. After this three month period, all patients will receive intrathecal baclofen treatment, with a follow-up after nine months. The primary outcome measurement will be the effect on activities of and participation in daily life measured by Goal Attainment Scaling. Secondary outcome measurements on the level of body functions include dystonia, spasticity, pain, comfort and sleep-related breathing disorders. Side effects will be monitored and we will study whether patient characteristics influence outcome.DiscussionThe results of this study will provide data for evidence-based use of intrathecal baclofen in dystonic cerebral palsy.Trial registrationNederlands Trial Register, NTR3642