Continuous Intrathecal Baclofen Therapy Research Articles

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.

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.

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

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

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.

Long-term follow-up on continuous intrathecal Baclofen therapy in non-ambulant children with intractable spastic Cerebral Palsy

BackgroundLittle is known about the long-term effects of Continuous intrathecal Baclofen (CITB) therapy in non-ambulant children with intractable spastic Cerebral Palsy (CP). AimTo determine whether short-term beneficial effects of CITB therapy are present at the long-term, and whether caregivers would choose CITB therapy for their child again considering the advantages and disadvantages encountered over the years. MethodsLong-term follow-up data were obtained of the children whom had previously participated in a RCT on CITB by the Dutch Study Group on Spasticity. Quality of life (QoL) was assessed by the Child Health Questionnaire (CHQ), current satisfaction with CITB was measured by use of a Visual Analogue Scale regarding previously set treatment goals, functioning in daily living was determined by a questionnaire concerning functioning of the child, and possible detrimental effects of CITB therapy encountered over the years were noted. All data were acquired via interview of the caregivers. ResultsAll 17 children of the former trial participated in this study. Previously identified significant positive effects on pain (CHQ 46.8 vs. 74.38, p = 0.002; VAS 2.4 vs. 8.01, p = 0.02), ease of care (VAS 2.0 vs. 7.26, p = 0.00), and mental health (CHQ 67.2 vs. 75.94, p = 0.010) were still present at the end of the trial. Novel significant positive effects were noted at six to nine years follow-up, i.e. significantly improved scores on the Parent Impact – Emotional subscale (CHQ 66.0 vs. 78.2, p = 0.008), Parent Impact – Time subscale (CHQ 68.9 vs. 91.72, p = 0.002), and the Physical Summary (CHQ 17.6 vs. 27.4, p = 0.019) compared to baseline. Ninety-four percent of the caregivers would choose CITB treatment again for their child again. ConclusionThe beneficial effects of CITB are present at the long term and caregiver satisfaction is high.

Continuous intrathecal baclofen therapy in children with cerebral palsy – when does improvement emerge?

The aim of the study was to explore the timing of effects of intrathecal baclofen therapy in children with cerebral palsy. Thirty five children with severe disabilities with cerebral palsy who started continuous intrathecal baclofen therapy (CITB) were followed for 18 months. Pain, number of awakenings during night, spasticity, GMFM-66 scores and PEDI scores were recorded the day before pump implantation and after 6 and 18 months of treatment respectively. Introduction of CITB was associated with changes across all ICF dimensions. Reduced pain and improved sleep occurred within 6 months of treatment. Social function improved within 6 months and continued to improve until 18 months of CITB. Mobility also improved, but with a latency. There seems to be a sequence of changes after introduction of continuous intrathecal baclofen in a child with cerebral palsy that may guide the multidisciplinary team in their timing of therapy during post-surgical follow-up.

Cerebrospinal fluid baclofen concentrations in patients undergoing continuous intrathecal baclofen therapy

The aim of this study was to report concentrations of cerebrospinal fluid (CSF) baclofen in children undergoing chronic intrathecal baclofen (ITB) infusions. CSF baclofen concentrations were analyzed in 53 specimens obtained by intrathecal catheter aspiration from 43 participants (28 males, 15 females; range 3-44y, mean 16y [SD 8y 11mo]), with functioning baclofen pumps and catheters. Daily ITB doses ranged from 70 to 1395 microg per day (mean 607 microg per day [SD 363], median 575). Baclofen concentration was quantified by high-pressure liquid chromatography and confirmed by injection onto a gas chromatograph. CSF baclofen concentrations from children receiving either simple continuous or complex infusions ranged from 0.2 to 20.0 microg/ml (mean 4.64 microg/ml, median 3.3 microg/ml). CSF baclofen concentrations from children receiving simple continuous infusions ranged from 0.5 to 12.9 (mean 4.7 microg/ml, median 3.55 microg/ml). There was no correlation between ITB dosage and CSF baclofen concentration. We conclude that baclofen concentration can be measured to determine if baclofen is present in CSF. However, there appears to be no correlation between the ITB dose infused and the corresponding CSF baclofen level.

Intrathecal baclofen therapy improves functional intelligibility of speech in cerebral palsy

Objective: To assess the effect of intrathecal baclofen on spastic dysarthia in cerebral palsy. Design: Single case study. Methods: Functional outcome measures, including the Assessment of Intelligibility of Dysarthric Speech, were performed before and after a trial of intrathecal baclofen in an adult patient with spastic dysarthria due to cerebral palsy. The patient proceeded to intrathecal baclofen pump implantation and was reassessed after six months of continuous intrathecal baclofen therapy. Results: Improvement in function including speech intelligibility was seen following the intrathecal baclofen trial. The improvement was sustained at six months post pump implantation. Conclusions: Intrathecal baclofen improved functional intelligibility of speech in a carefully selected subject. The Assessment of Intelligibility of Dysarthric Speech was found to be a useful quantitative tool to assess the effect of intrathecal baclofen on spastic dysarthria.

Dysautonomia syndrome in the acute recovery phase after traumatic brain injury: relief with intrathecal Baclofen therapy

In the initial phase of severe head injury, dysautonomic abnormalities are frequent. Within the framework of a prospective study, evaluating the efficacy of continuous intrathecal Baclofen therapy (CIBT) on hypertonia during the initial recovery phase of severe head injury, the authors report on the preliminary results of this treatment on paroxysmal dysautonomia about four patients. Continuous intrathecal Baclofen infusion was first delivered, for a test period, continuously for 6 days. If a relapse of dysautonomia occurred at the end of the test period, an implantation of a continuous intrathecal infusion pump delivering Baclofen was performed. Results were assessed with four continuous variables; duration (days), dose of Baclofen per day (µg/d), number of dysautonomic paroxysmal episodes per day, and initial recovery evaluated by a scale of the first initial stages of head injury coma recovery. For three patients: (1) the number of dysautonomic paroxysmal episodes per day and the doses of Baclofen during the follow-up period were correlated (p = 0.02, p < 0.001, p = 0.008, respectively, distribution-free test of Spearman), (2) during the test period and the relapse after the test period, the number of paroxysmal episodes and the Baclofen dose are correlated to p < 0.05, p = 0.03, p = 0.04, respectively (distribution-free test of Spearman). The second statistical test was used to prove that Baclofen doses and number of paroxysmal dysautonomic episodes are correlated independently of the duration of follow-up. The fourth patient improved with CIBT without any recurrence at the end of the treatment test period. For the four patients, recovery score increased during the overall follow-up. In the authors' experience CIBT is very efficient to control paroxysmal dysautonomia during the initial recovery phase in severe head injury, and seems to facilitate recovery.

Continuous intrathecal baclofen infusions induced a marked increase of the transcranially evoked silent period in a patient with generalized dystonia

We observed a marked prolongation of the transcranially evoked silent period during continuous intrathecal administration of high doses of the gamma-aminobutyric acid (GABA)B receptor agonist baclofen in a patient with generalized dystonia. Size of motor evoked potentials and central conduction time remained unchanged during intrathecal baclofen administration. The selective prolongation of the silent period during high-dose continuous intrathecal baclofen therapy supports the notion that GABAB-ergic intracortical interneurons play a part in the generation of the transcranially evoked silent period. © 1998 John Wiley & Sons, Inc. Muscle Nerve 21:1209–1212, 1998.

Continuous intrathecal baclofen infusions induced a marked increase of the transcranially evoked silent period in a patient with generalized dystonia

We observed a marked prolongation of the transcranially evoked silent period during continuous intrathecal administration of high doses of the gamma-aminobutyric acid (GABA)B receptor agonist baclofen in a patient with generalized dystonia. Size of motor evoked potentials and central conduction time remained unchanged during intrathecal baclofen administration. The selective prolongation of the silent period during high-dose continuous intrathecal baclofen therapy supports the notion that GABA(B)-ergic intracortical interneurons play a part in the generation of the transcranially evoked silent period.

Intrathecal baclofen: does tolerance occur?

Concern over the development of tolerance in patients on continuous intrathecal baclofen therapy has arisen as this new form of treatment for spasticity has gained wider use. We have studied time-dose relationships in 18 spinal cord injured patients who have undergone intrathecal baclofen infusion pump implantation since February 1988 in our facility. Our data show that there was a significant increase in baclofen dosage needed to control spasticity during the first 12 months post implantation. After 12 months, however, no significant changes in dosage requirement was detected. In addition, there was no significant difference between completely and incompletely spinal cord injured patients with regard to both the initial dose and the tolerance trend.