ITB Therapy Research Articles

Safety and efficacy of intrathecal baclofen trials for the treatment of hypertonia: a retrospective cohort study.

Intrathecal baclofen (ITB) is an effective treatment for refractory hypertonia in children. ITB has long been effective for the treatment of spasticity, and indications have naturally evolved to include dystonia and mixed pediatric movement disorders (PMDs). The established uses for ITB trials are insurance prerequisite, mixed tone, and family request. Despite agreement for ITB therapy by a multidisciplinary group of subspecialists in a complex PMD program, insurance companies often require an ITB trial be performed. A longitudinal cohort was identified to determine the safety and efficacy of ITB trials and to determine the utility of test dosing in this population. Retrospective data analysis was performed for patients with hypertonia who underwent ITB bolus trials at the authors' institution between 2021 and 2023. Nonmodifiable risk factors and clinical variables were collected. Thirty-one patients (11 female) underwent 32 ITB trials. Of these patients, 67.7% had a diagnosis of mixed hypertonia, 32.3% pure spasticity, and 9.1% secondary dystonia. The mean age at test dose was 12.8 years, and 58.1% of patients were born premature. The mode Gross Motor Function Classification System score was 5. The mean difference in Barry-Albright Dystonia Scale (BADS) scores was -7.33 points (p = 0.01) at 2.5 hours postoperatively. The mean difference in upper-extremity modified Ashworth Scale (mAS) scores was -5.36 points (p = 0.003), and that for lower-extremity mAS scores was -6.61 (p < 0.001). In total, 21.9% of patients developed a post-dural puncture headache. Conversion to a permanent baclofen pump was performed in 22/32 (68.8%) patients. Of those who did not pursue pump placement, 1 patient had high surgical risk, 1 had an ineffective response, 1 had a bad reaction to the test dose and cited both regression and increased discomfort, and 2 declined despite an effective trial owing to family preferences. ITB trials require hospitalization in some form and carry risks of procedural complications. The decision to pursue a trial should be made on a case-by-case basis by clinicians and should not be determined by insurance companies. The complication rate of ITB trials is high, and a test dose is unnecessary in this fragile population.

Complications of Intrathecal Baclofen Pump Therapy: An Institutional Experience from Saudi Arabia.

The intrathecal baclofen pump (ITB) is one of the advanced treatment options in the management of spasticity. This retrospective cohort study was conducted to identify the complications of ITB treatment at a tertiary care rehabilitation facility. Various demographic and technical factors were analyzed, which are less often reported in the literature. All patients with ITB who had their refill at the ITB clinic between November 2019 and March 2020 were included. Of 48 patients, 17 patients had 18 (37.5%) ITB-related complications. Catheter-related complications were most common, whereas loss of efficacy (16.7%) and baclofen withdrawal (14.5%) were the most common outcomes of complications. Only catheter occlusion had a significant relationship with the pattern of spastic quadriparesis (p = 0.001). Gender, rehabilitation diagnosis, patients' residence, and facility of ITB placement did not have significant association. Similarly, age, distance from hospital, disease onset, ITB therapy duration, and baclofen dose were not statistically significant in relation to ITB-related complications.

Calcification of the pump pouch in patients receiving ITB therapy: A rare complication affecting refill procedure – Analysis of two cases

BackgroundIntrathecal baclofen therapy (ITB) is an effective treatment for reducing spasticity but can be associated with various complications, including infection and implant malfunction. MethodsThis retrospective cohort study analyzed refill reports, complications, and functional outcomes in 40 consecutive patients with intractable spasticity or dystonia undergoing ITB. ResultsAmong the 40 patients, 8 experienced complications, including two cases of calcification of the baclofen pump pouch and surrounding tissue, a rare complication not extensively described in the literature. DiscussionCalcification, in addition to port access difficulties, could lead to drug delivery failure. We hypothesize that calcification may result from microtrauma or needlestick injury to the subcutaneous tissue and muscle fascia. The length of time the pump stays in the pocket could also contribute to favoring this phenomenon. ConclusionAs the number of patients receiving ITB increases, physicians must be aware of potential life-threatening complications. The risk of pouch calcification should be further investigated and considered in managing patients undergoing ITB, as it could significantly impact patient care.

Intrathecal Baclofen Therapy for Spastic Paralysis

Intrathecal baclofen therapy(ITB)is a recognized treatment for spastic paralysis. Direct injection of baclofen into the intrathecal space through a catheter from a battery-loaded pump implanted in the abdomen allows effective administration of the drug at much lower doses than oral administration. ITB therapy is indicated for patients with severe spastic paraparesis that do not respond sufficiently to first-line medical therapy or in whom the side effects complicate treatment. A pump implantation is considered in cases where spasticity is improved after intrathecal infection of a small amount of baclofen. Postoperative complications include CSF leakage, infection and device malfunction. Postoperatively, the patient requires baclofen refills every 2-3 months and pump replacement surgery every 6-7 years. Currently, ITB therapy is not widespread in Japan, although further popularization is expected.

A case of exacerbation of spasticity during ITB therapy for spasticity due to syringomyelia

A case of exacerbation of spasticity during ITB therapy for spasticity due to syringomyelia

Intrathecal baclofen pumps in the management of hypertonia in childhood: a UK and Ireland wide survey

BackgroundIntrathecal baclofen (ITB) is a useful treatment for hypertonia where non-invasive treatments have been ineffective or poorly tolerated. There is an absence of national guidance on selection criteria and a...

The Impact of Intrathecal Baclofen Therapy on Health-related Quality of Life for Children with Marked Hypertonia

ABSTRACT Purpose: To investigate the effects of intrathecal baclofen therapy (ITB) on health-related quality of life for children with cerebral palsy and neurological conditions. Method: This study is part of a longitudinal, multicentre audit. The primary outcome measure, the Caregiver Priorities and Child Health Index of Life with Disabilities, was completed at baseline, 6 and 12 months post ITB implant. Results: Forty subjects with cerebral palsy and other neurological conditions demonstrated significant improvement in aspects of health-related quality of life following ITB therapy, mean change 42.3 (SD 14.9) at baseline to 53.3 (SD 14.7) at 12 months (p< .001). Conclusion: Evidence to demonstrate the utility of ITB in pediatric populations beyond spasticity and dystonia reduction is limited. Our findings suggest that ITB improves aspects of quality of life, comfort, and ease of caregiving in children with cerebral palsy and other neurological conditions.

A case of ITB therapy for refractory severe focal dystonia

A case of ITB therapy for refractory severe focal dystonia

Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS)

BackgroundIntrathecal baclofen (ITB) is a treatment option for patients with severe poststroke spasticity (PSS) who have not reached their therapy goal with other interventions.Methods’Spasticity In Stroke–Randomised Study' (SISTERS) was a...

Long-Term Dosing of Intrathecal Baclofen in the Treatment of Spasticity After Acquired Brain Injury

BackgroundIntrathecal baclofen (ITB) often is used to treat severe spasticity of cerebral origin. Although literature exists regarding the efficacy of ITB, there has been minimal investigation related to dosing in the adult-acquired brain injury population, particularly at long-term duration. ObjectiveTo investigate long-term dosing of ITB in adult patients with spasticity of cerebral origin due traumatic brain injury (TBI), stroke, and hypoxic-ischemic encephalopathy (HIE). DesignRetrospective cohort study. SettingAn academic outpatient rehabilitation clinic. PatientsForty-two adult patients with spasticity secondary to TBI, stroke, or HIE treated with ITB for greater than 3 years. MethodsMedical records and device manufacturer records of included patients were reviewed to obtain demographic data, dosing information, dates of pump and catheter placements, and revisions. Main Outcome MeasureAverage daily ITB doses and mean change in ITB dose over 1, 2, and 3 years. Goal of ITB treatment (active function versus comfort/care/positioning) also was compared. ResultsOf 42 total patients, spasticity was attributed to either TBI (n = 19), stroke (n = 11), or HIE (n = 12). The mean (standard deviation) age was 35.21 (10.17), 56.7 (13.1), and 35.1 (12.4) years for the TBI, stroke, and HIE groups, respectively (P < .001). There was a significant difference in the goal of therapy with “improving functional independence,” accounting for 27.8%, 72.8%, and 0% in the TBI, stroke, and HIE groups, respectively (P = .002). The mean duration of ITB therapy was 8.5 (5.0), 7.8 (3.4), and 9.1 (4.6) years in the TBI, stroke, and HIE groups, respectively (P = .79). The mean daily ITB dose was 596.9 (322.8) μg/d, 513.2 (405.7) μg/d, and 705.2 (271.7) μg/d for the TBI, stroke, and HIE groups, respectively (P = .39). In the subset of the cohort with ITB therapy for more than 5 years, the mean percent change in daily ITB dose between time of chart review and 1, 2, and 3 years previously was 7.3% (13.6), 12.7% (16), and 24.7% (50.3), respectively. A complex dosing pattern was used more frequently in those with stroke (36.4%) compared with the TBI and HIE (9.7%) groups (P = .04). ConclusionDespite the long-term use of ITB therapy in this cohort, the mean daily dose of ITB continued to require adjustments. There was no significant difference in the mean daily dose between patients with a diagnosis of TBI, stroke, or HIE. A complex dosing pattern was used more frequently in patients with stroke. Level of EvidenceIII

Cost-effectiveness of Intrathecal Baclofen Therapy in severe refractory non-focal disabling spasticity: a Spanish hospital perspective

ABSTRACTBackground: Current knowledge about long-term economic consequences of Intrathecal Baclofen Therapy (ITB Therapy®) is incomplete.Methods: A markov model was developed to estimate long-term clinical and economic outcomes with ITB Therapy® and conventional medical management of severe refractory non-focal disabling spasticity. Clinical and cost inputs were obtained through a non-interventional, prospective, observational study in a Spanish neurorehabilitation hospital.Results: ITB Therapy® increased remaining lifetime costs by €35,605 and resulted in a gain of 1.06 quality-adjusted life-years (QALYs), thus showing an incremental cost-effectiveness ratio (ICER) of €33,619/QALY gained. In alternative scenarios, reflecting other clinical settings and management options, considerably lower ICER values were obtained. In particular, opportunities were identified to improve efficiency by setting clinically and economically sound targets for post-operation length of stay.Conclusion: In the Spanish setting, ITB Therapy® resulted in an ICER close to €30,000/QALY gained; potential ways to reduce costs and further enhance efficiency can be identified.

Long-term effects of intrathecal baclofen in multiple sclerosis

ObjectivesSpasticity is associated with various neurological conditions. In this study the authors analyzed the long term effects of intrathecal baclofen therapy in multiple sclerosis and evalued the benefits of the treatment on spasticity, disability, pain, spasm frequency and rated the incidence of side effects. Patients and methodsA records of 123 patients, with a severe, progressive and refractory to medical therapy spasticity from different causes, underwent baclofen pump placement, after a bolus test, from 2000 to 2012,under Department of Neurosurgery at the Second University of Naples/Italy. We present our experience in treating 28 subjects that was affected by multiple sclerosis. For all patients we reviewed long-term response to therapy, surgical technique, surgery- and pump-related complications. Every patients were evaluated by means of the Modified Ashworth Scale (MAS), Penn Spasm Frequency Scale (SFS), Visual analogue Scale For Pain (VAS), Barthel index (BI) and Self Rating Depression Scale (SDS) ResultsDuring follow up the mean MAS score for upper and lower extremities decrease significantly. Also SFS's decrease was statistically significant. This resulted in a dramatic improvement of BI. Furthermore, we observed a marked improvement in VAS and SDS. ConclusionsIntrathecal baclofen provides effective long-term treatment of spasticity multiple sclerosis related. ITB therapy increases the quality of lifestyle and functional independence in appropriately selected cases.

Understanding the reasons for delayed referral for intrathecal baclofen therapy in pediatric patients with severe spasticity.

Intrathecal baclofen therapy (ITB) has been used in the treatment of spasticity and dystonia. In our pediatric movement disorder clinic, we noted a delay in referral of patients for consideration of ITB. Often, only after years of failed medical therapy, a baclofen pump is considered. This study attempts to investigate the prevalence, length and causes of the delay. A retrospective, outcome analysis was performed. We conducted a survey of 30 pediatric patients who received baclofen pumps between the ages of 5 and 23. Patients were divided into two groups (before and after ITB approval by the US Food and Drug Administration in 1996) (FDA/Center for Drug Evaluation and Research, 2014; Ridley and Rawlins, J Neurosci Nurs 38:72-82, 2006; Medical Advisory Secretariat, Ont Health Technol Assess Ser 5:1-93, 2005). Information was collected regarding their onset of spasticity, attempted treatments, pump referral, satisfaction, and resulting change in the quality of life. There was a delay in referral in most cases investigated. Average time to baclofen pump implantation, after initial onset of spasticity, was 5.14years (group A) and 11.7years (group B). Out of the subjects who reported diminished effects or no effect of pharmacological treatment, 93% of these respondents reported that ITB had a dramatic long-lasting effect on their spasticity. Of 30 patients, 28 reported effectiveness of ITB, and 26 of 30 subjects reported an improved quality and ease of life. Despite the limitations of this subjective retrospective analysis of outcomes and delay in referral, the opinions of the parents and caregivers should be considered. Earlier referral for ITB therapy may better treat severe spasticity in pediatric patients.

Timing of intrathecal baclofen therapy in persons with acquired brain injury: Influence on outcome

Objective: Evaluation of the effects of intrathecal baclofen therapy (ITB) delivered by a pump implanted at a very early stage in acquired brain injury (ABI).Study design: This investigation was a longitudinal prospective observational study, including a series of 13 ABI implanted within 6 months of the acute events.Main outcome measure: The Modified Ashworth Scale (MAS) and Spasms Frequency Score (SFS) have been used as a primary outcome measure. The Disability Rating Scale (DRS) and Level of Cognitive Functioning (LCF) scores have been computed in order to verify possible interferences of baclofen therapy at an early stage on a global outcome. An intrathecal bolus test was not performed. Drug tolerability was tested by oral administration of baclofen 100 mg.Results: Reduction of spasticity and spasms frequency were measured 3 months after patients received the implant and at the 1-year follow-up. There was no difference found for global outcome measure between the group of patients who received the implant earlier (within 3 months) compared to the group who received it later (between 3–6 months).Conclusion: ITB therapy in ABI should be considered as early as possible. The implants are safe and effective in reducing spasticity. An intrathecal bolus test was not compulsory in ABI.

The Use of Intrathecal Baclofen Therapy for Myoclonus in a Patient With Lance Adams Syndrome

Myoclonus is a movement disorder characterized by the sudden onset of jerking, “shock-like” involuntary movements that may be triggered by voluntary movement or sensorystimulation. Lance Adams syndrome (LAS) is a type of myoclonus associated with hypoxicinjury to the brain. It was initially described by Lance and Adams in 1963 in a series of 4patients in whom action myoclonus developed as sequelae of hypoxic encephalopathy [1].Since that initial description, more than 100 cases have been reported in medical literature;however, LAS remains a rare condition.When myoclonus is secondary to hypoxic events, it can occur as 2 variants [2]: (1) acuteposthypoxic myoclonus (PHM), which usually occurs within 24 hours of the insult and ischaracterized by generalized myoclonus and poor prognosis; and (2) chronic PHM or LAS,which begins after a delay of generally a few days to a month and manifests predominatelyas action myoclonus. The presence of LAS adds significantly to the functional decline andreduction in quality of life in patients with anoxic brain injury because it causes additionaldifficulties with motor control, dexterity, and pain.Therapeutic options for persons with PHM are scarce and usually unsuccessful. Multiplepharmacologic treatments have been suggested, including clonazepam, levetiracetam, andlevodopa [2]. Baclofen also has been used in both experimental models [3] and in humans[4,5] with promising results.Theuseofintrathecalbaclofen(ITB)therapyinpatientswithposthypoxicmyoclonushasnotbeendescribedintheliteraturetoourknowledge.WepresentacaseofPHMthatimprovedwiththe use of ITB therapy.

Outcomes of intratechal baclofen (itb) therapy in spacticity

Spasticity is associated with various neurological conditions. Intrathecal baclofen (ITB) is one of the popular treatments for severe spasticity. In this paper we present our experience in treating 30 patients with both spinal and supraspinal spasticity with chronic infusion of Baclofen to evaluate the long term efficacy of this treatment on spasticity, disability and pain, and to evaluate the side effects of intrathecal Baclofen. The medical records of 30 patients who underwent baclofen pump placement from 2000 to 2010 under Department of Neurosurgery at the University of Akdeniz at Antalya/Turkey, were reviewed. All study subjects had diffuse chronic, severe, and generalized spasticity (Ashworth score ≥ 3), and had shown inadequate response to various oral antispastic drugs including baclofen. All patients were evaluated by means of the Ashworth score, spasm frequency, Barthel index, Rankin scales and VAS. Spasticity and spasm frequency and pain scores were clinically and statistically decreased in all patients. ITB therapy increases the quality of lifestyle and functional independence by reducing not only cerebral but also spinal related spasticity in appropriately selected cases.

Upper Limbs Function After Intrathecal Baclofen Therapy in Children With Secondary Dystonia

Different studies show the efficacy of intrathecal baclofen therapy (ITB) in patients with secondary dystonia because of cerebral palsy. These studies only report improvements related to dystonia reduction; however, none of them have assessed whether such benefit is reflected in limb function. The purpose of our study is to determine whether the effects ITB therapy in patients with secondary dystonia to cerebral palsy, in addition to reducing dystonia, may also improve upper limb function. Eleven patients with secondary dystonia, classified as levels 3 and 4 of the Gross Motor Function Classification System, were treated with ITB. The mean age at implant was 11.3 (SD+/-3.02) years.Before treatment and 12 months after implant, the patients were evaluated by the Melbourne Assessment of Unilateral Upper Limb and the Barry Albright scale to assess upper limb function and dystonia, respectively. We found a statistically significant improvement in both scales. The Melbourne scale total percentage score, for both limbs, increased in all patients (P<0.05). Dystonia assessed by the Barry Albright scale scale decreased significantly by 15% from baseline to 12 months follow-up (P<0.05). In patients with secondary dystonia treated with ITB, functional improvement of the upper limbs was observed in addition to dystonia reduction. In patients with secondary dystonia, ITB is a treatment that aims to achieve a general reduction of dystonia; this study want to show the influence that this reduction has to functional ability of patient. Therapeutic study: level 4.

髄腔内バクロフェン (ITB) 療法施行中にカテーテルトラブルを来たした2例

髄腔内バクロフェン (ITB) 療法施行中にカテーテルトラブルを来たした2例

Baclofen Pump Implantation and Spinal Fusion in Children

Retrospective clinical and radiographic review of complications related to intrathecal baclofen therapy (ITB) and posterior spine fusion (PSF) in patients with cerebral palsy. To report the technical considerations and complications associated with ITB in patients undergoing PSF. A common treatment for spasticity in children with cerebral palsy is ITB. This population also has a high incidence of severe spinal deformities requiring PSF. There were 4 groups: A, 26 patients with PSF before ITB; B, 11 patients who underwent PSF and ITB concurrently; C, 25 patients with PSF after ITB; and D, the control group: 103 patients with ITB only. Complications and infections were tabulated from a retrospective chart review and ongoing surveillance data. Multiple chi analyses were used to compare the number of patients who experienced complications and infections among the groups. The operative sequence and catheter management techniques for the various scenarios are described in detail in the text. The outcome by group was as follows: group A had 5 catheter malfunctions and 2 infections at the pump site, group B had 2 catheter malfunctions, 1 hypermobile pump and 1 infection at the spinal site, group C had 3 catheter malfunctions, 1 infection at the pump site and 1 infection at the spinal site. The control group had 23 catheter malfunctions, 5 pump failures, 8 infections at the pump site, and 1 infection at the spinal site. Multiple chi analyses showed no difference in the number of infection or device/catheter complications among any of the groups. The rate of ITB therapy complications is not increased despite PSF in any order of the procedures. There are technical details in each situation that require attention. With understanding of the appropriate techniques of catheter management, ITB pumps can be implanted and managed without an increased complication rate before, during or after spinal fusion surgery.

Intrathecal baclofen and morphine in multiple sclerosis patients with severe pain and spasticity

Sirs: Spasticity and pain are common features of multiple sclerosis (MS) [6]. Because pain may be relieved by anti-spasticity measures, treatment of spasticity should precede specific pain management. About 20 % of MS patients are either intolerant to oral medications or continue to have significant spasticity despite maximal oral dosage. These patients are optimally managed with continuous intrathecal baclofen infusion (ITB) administered via a surgically implanted programmable pump, a FDA-approved treatment modality [7, 8]. For patients with pain associated with spasticity, ITB therapy usually provides adequate relief of both symptoms. Apart from spasticity other pain syndromes may occur in MS. Neuropathic pain is the most common, may be disabling in severity and resistant to oral pain medications. Intrathecal morphine (ITM) is an established form of treatment for intractable pain syndromes and is beneficial in the majority of such patients [2, 4, 5]. In this retrospective study, we investigated the long-term efficacy and safety of ITB/ITM combination in nine MS patients [3]. All nine patients were resistant or intolerant of maximal oral anti-spasticity medications and all classes of standard oral pain medications including narcotics (Table 1). Patients (all with Ashworth scores of 4 or greater) were first assessed for response to ITB. A screening test dose of 75 mg of baclofen was injected into the CSF and this resulted in complete relief of spasticity with greater than a 2 point drop on the Ashworth spasticity score. All patients underwent successful surgical implantation of Medtronic programmable pumps. Postimplantation, ITB dose was optimized for relief of spasticity (Table 1). All clinical assessments for spasticity were graded according to the Ashworth Spasticity Scale [7]. Although with ITB treatment patients had a decrease in pain associated with spasticity, neuropathic pain was unaffected and patients with Visual Pain Analogue Scale Scores (VPASS) [3] of 8 or greater were selected for addition of ITM to ITB. Because morphine has an anti-spasticity effect and both agents depress respiration, doses of medications were initially conservative. The mix was set to deliver a rate of half the previous daily dose of baclofen and 500 mg of morphine a day. Subsequent dose and mixture adjustments were done according to patient response to pain (utilizing VPASS) and spasticity (Ashworth score/functional assessment). This study was approved by the Institutional Review Board (IRB) of St. Luke’s-Roosevelt Hospital. All nine MS patients who had persistent severe pain despite optimal relief of spasticity with ITB therapy had excellent analgesic responses to the addition of ITM. The mean VPASS scores for the nine patients decreased from 8.6 to 1.4 and these responses were sustained over an average of 6.2 years (1–10 years follow-up as shown in Table 2). Therapeutic doses varied widely among individuals with baclofen ranging from 5 to 1200 μg a day and morphine from 800 to 9500 μg a day. In the patient taking 5 μg of baclofen decreasing the dose below this leads to an intolerable degree of spasticity whereas at this dose she has enough tone to transfer. There were no serious adverse effects noted in any of our patients. None of the patients developed respiratory depression. Two of the 9 patients (P04, P08) initially had transient nausea and 2 patients reported worsening constipation (P03, P08), which responded well to a bowel regimen for relief of constipation. One patient developed bilateral lower limb edema (P05), a recognized complication of ITM [1]. In this study, we showed that ITB/ITM in combination has longterm efficacy (mean follow-up period of 6.2 years) in treating patients with intractable pain and spasticity. The shortcomings of this study are the small number of patients, the lack of blinding, and being retrospective.