Continuous Intrathecal Baclofen Infusion by a Programmable Pump in 131 Consecutive Patients with Severe Spasticity of Spinal Origin

We began this study to determine the efficacy and safety of intrathecal baclofen (ITB) delivered by a programmable pump for the treatment of severe spasticity of spinal cord origin. One hundred fifty two patients with severe spasticity of spinal origin, refractory to oral baclofen, or who experienced intolerable side‐effects were given a test dose of ITB. Only those who had a satisfactory response were considered to be appropriate for pump implantation. All but one of the 152 patients had a satisfactory response, and the pump was implanted in 131 patients. Pre‐ and postoperative spasticity scores were compared and analyzed. The mean Ashworth score for rigidity decreased from 4.2 preoperatively to 1.3 (p < 0.0005) on ITB. The spasm score decreased from a mean of 3.4 to 0.6 (p < 0.0005). Reduction of spasticity resulted in improved levels of physical activity, decreased pain, and augmentation of sleep. Drug‐related complications included constipation, muscular hypotonia, urinary retention, erectile dysfunction, nausea, dizziness, drowsiness, hypotension and bradycardia as well as tolerance to baclofen. Some patients experienced post‐spinal puncture headaches. Catheter‐related problems included occlusions, breaks, punctures, and dislodgments. Superficial pump pocket infection, pocket erosion, cerebrospinal fluid (CSF) leak, post‐spinal puncture headache, and meningitis were some of the procedure‐related complications. Two pumps flipped and another pump valve was stuck. We conclude that long‐term intrathecal baclofen by an implanted programmable pump is a safe and effective method of treating severe intractable spinal spasticity.     

Long term effect (more than five years) of intrathecal baclofen on impairment, disability, and quality of life in patients with severe spasticity of spinal origin

OBJECTIVES: To evaluate long term change in impairment, disability, and health related functional status in patients with severe spasticity who received intrathecal baclofen. METHODS: A long term (more than five years) observational longitudinal follow up study assessing 21 patients who received intrathecal baclofen given by programmable pump. Patients had chronic disabling spasticity which did not respond to oral antispasmolytic agents. Clinical efficacy was assessed by the Ashworth scale and spasm score; disability by the expanded disability status scale (EDSS), ambulation index (AI), and incapacity status scale (ISS); and health related quality of life by the sickness impact profile (SIP) and the Hopkins symptom checklist (HSCL). RESULTS: Compared with pretreatment values, there was a significant improvement in clinical efficacy (Ashworth scale and spasm score, p<0.05) but a small but significant worsening of disability (EDSS, AI, and ISS, p<0.05). Comparing pretreatment with 26 weeks after pump implantation, a worsening was observed in disability (EDSS and ISS, p<0.05) and perceived health status (SIP, psychosocial dimension, p<0.05). CONCLUSIONS: Long term administration of intrathecal baclofen delivered by an implanted programmable pump resulted in improved clinical efficacy but not in improvement in disability or perceived health status.     

Intrathecal baclofen therapy in children with severe spasticity: Outcome and complications

Objective: To investigate clinical efficacy and incidence of complications regarding intrathecal baclofen (ITB) therapy in children.

Methods: Retrospective medical chart review of 15 paediatric patients with congenital brain injuries who underwent ITB implantation for treatment of severe spasticity between 2003 and 2009.

Results: Compared to the preoperative state, ITB therapy significantly reduced spasticity of lower limbs with corresponding decrease of the modified Ashworth scale (p?p?=?0.001). Cobb angle of patients with scoliosis prior to ITB therapy (n?=?8) increased significantly (p?Conclusion: Intrathecal baclofen is an effective therapy option for paediatric patients to significantly reduce spasticity of lower limbs. The high incidence of complications implicates the need for a close monitoring of the patients especially in the early post-operative period.     

Functional improvement in patients with severe spinal spasticity treated with chronic intrathecal baclofen infusion

In this retrospective study we evaluated the efficacy and functional benefits of chronic intrathecal baclofen infusion in severe spinal spasticity. Twenty patients with a diagnosis of severe intractable spinal spasticity were evaluated prior to implantation of a programmable pump for chronic intrathecal baclofen therapy and at follow up, which ranged from 12 to 36 months (mean 22.4 months). The mean age of the patients was 39.1 years. The prevailing pathology was multiple sclerosis. All were unable to walk. Patient assessment was based on the Ashworth Scale, the Spasms Frequency Scale, self-reported pain and Functional Independence Measure (FIM) scores. The Wilcoxon test was used for statistical analysis. A statistically significant decrease in muscle tone, spasms and pain was observed in all the patients. The Ashworth score decreased from 4.4 to 1.8, the spasms frequency score from 2.5 to 0.5 and the self-reported pain score from 5.5 to 2.3. The FIM score also showed a statistically significant change (increasing from a mean of 33.8 to 58.7). Two patients in employment were able to return to work. No severe side effects were observed. Chronic intrathecal baclofen infusion was seen to produce a functional improvement in patients with severe spinal spasticity, particularly as regards bathing, comfortable wheelchair sitting and mobility.     

Continuous intrathecal baclofen infusion in severe spasticity after traumatic or hypoxic brain injury

Severe spinal spasticity has been shown to be a good indication for continuous intrathecal baclofen infusion (CIBI), but there is only limited experience with this treatment in patients with supraspinal spasticity. Eighteen patients with severe spasticity from traumatic or hypoxic brain injury were treated with CIBI. In all patients spasticity could be reduced significantly. The mean Ashworth score was reduced from 4.5 to 2.33 and the mean Spasm frequency score from 2.16 to 0.94. This reduction of spasticity led to a marked pain reduction. Nursing, perineal care and mobilization became much easier. The complication rate was low. In this series we saw one infection in the pump pocket, one epileptic seizure after a bolus application of baclofen and one spinal catheter displacement. The results are similar to those reported from series of patients with spinal spasticity and correspond to the limited experience we have so far with supraspinal spasticity patients. To prevent limb contractures CIBI should be performed as soon as the patient is in a stable clinical condition after brain injury. Further prospective clinical trials will be necessary to obtain more experience with patients suffering from supraspinal spasticity. Received: 8 January 1996 Received in revised form: 18 September 1996 Accepted: 23 September 1996     

Continuous infusion of intrathecal baclofen: long-term effects on spasticity in spinal cord injury

The effects of intrathecal baclofen infusion were studied in 9 spinal cord injury patients whose spasticity had been refractory to oral medications. In a two stage, placebo controlled trial, baclofen was administered into the lumbar intrathecal space and subsequent clinical and neurophysiologic changes were assessed. In stage 1, 9 patients underwent a 5 day percutaneous infusion of baclofen and placebo via an external pump. Ashworth and reflex scores were assessed at time of enrollment, after infusion of that amount of baclofen which provided optimal spasticity control and after intrathecal infusion of placebo. The mean Ashworth grade decreased from 3.78 +/- 1.34 to 1.16 +/- 0.48 (p less than 0.001) while mean reflex score decreased from 3.57 +/- 1.05 to 0.64 +/- 0.87 (p less than 0.001). These values differed significantly from those associated with placebo therapy (Ashworth grade--2.54 +/- 1.04, p less than 0.001; reflex score--2.56 +/- 1.04, p less than 0.01). Objective improvements in functional abilities and independence were noted in 8 patients, while somatosensory and brainstem auditory evoked potentials were unchanged in all patients. Urodynamic evaluation revealed increased bladder capacity in 3 patients, while in 4 no change was observed. In Stage 2, permanent programmable infusion pumps were implanted in 7 patients who demonstrated a good response during Stage 1. In this group, mean Ashworth score decreased from 3.79 +/- 0.69 to 2 +/- 0.96 (p less than 0.001) and mean reflex score decreased from 3.85 +/- 0.62 to 2.18 +/- 0.43 (p less than 0.001). Baclofen dosage increased from 182 +/- 135 to 528 +/- 266 mcg/day over the 3-22 month follow-up period. Most of the dosage increase occurred within the initial 12 months following infusion pump implantation and tended to plateau thereafter. Minor complications such as catheter dislodgement/kinking and nausea occurred infrequently while no device related infections were observed. There was no clinical evidence of any significant baclofen neurotoxicity either in Stage 1 or 2. The only ambulatory patient developed marked lower extremity weakness during Stage 1 intrathecal baclofen infusion and was temporarily unable to walk. We conclude that continuous administration of intrathecal baclofen is an effective and safe modality for spasticity control in patients who are refractory to oral medications.     

Cardiovascular alterations heralded by intrathecal baclofen bolus

We describe two patients in whom serious bradycardia and arterial hypotension occurred after a small intrathecal baclofen (ITB) test bolus. Both patients suffered from severe spasticity (one due to brain injury, one due to spinal cord injury). Medical history and diagnostic examinations revealed no previous cardiological problems. Ten minutes following a 50 μg ITB bolus, patient 1 developed bradycardia (58 bpm) and incomplete right branch block, lasting for 3 hours. In patient 2, a 20 μg ITB bolus was followed after 5 minutes by severe bradycardia (30 bpm) and hypotension (60/30 mmHg), without loss of consciousness, lasting for 10 minutes. Exaggerated muscle tone was alleviated in both patients after 2 hours by the applied doses. Neither patient underwent implantation of a permanent pump system, both were continued on oral baclofen. Despite numerous unremarkable repeat cardiological exams, both patients suffered fatal cardiac arrest one and two months later, respectively. Our observations suggest that ITB may herald cardiovascular dysfunction in predisposed patients. Careful cardiological examination before ITB treatment, and close monitoring during ITB testing in particular, is advised.     

Paradoxical Worsening of Spasticity and Pain in the Lower Extremities After Increasing the Dose of Intrathecal Baclofen—Case Report

Objectives: Some patients with spasticity and pain in the extremities fail to respond to increases in the dose of intrathecally delivered baclofen. Materials and Methods: We report a 78‐year‐old man with severe spasticity and pain in the lumbar region and both lower extremities because of ossification of the posterior longitudinal ligament, spinal canal stenosis, and cerebral infarction. He was severely disabled and bedridden. Earlier surgical interventions (spinal cord stimulation and deep brain stimulation) had failed. Results: He underwent a screening test for intrathecal baclofen (ITB) therapy. The intrathecal injection of 50 µg baclofen severely aggravated his spasticity and pain and concomitantly elicited myoclonic‐like involuntary movements in both lower extremities. Although 25 µg baclofen produced similar results, overt improvements were obtained with 12.5 µg, and he underwent implantation of an ITB pump. His spasticity and pain responded to initial daily doses of 12.5 µg. To obtain further improvements, we gradually increased the daily dose to 40 µg; however, this severely increased his spasticity and pain in both lower extremities and concomitantly elicited myoclonic‐like involuntary movements. He is being maintained on a daily dose of 20 µg/day. Conclusions: We suggest that in patients who experience symptom aggravation at increased ITB doses, potential causative factors and ITB system malfunction should first be ruled out, and consideration should then be given to decreasing the ITB dose.     

Intrathecal baclofen therapy to spasticity]

Intrathecal baclofen injection (ITB) has been available since April, 2006 in Japan. According to the clinical trial data, ITB reduced continuously the average Ashworth spasticity score (1 no spasticity-5 completely contracted) from 3.85 to 1.84 or below as well as the average spasm score (0 no spasm-4 more than 10 spasms hour) from 2.56 to 0.75. It also reduced the number of patients with severe pain from 45% to 17% as well as the number of patients with severe compressive sensation from 65% to 11%. The effect was very dramatic and there have been no severe side effect. ITB seems effective and useful to patients suffered from marked spasticity. It appears also safe when appropriate patients are selected and careful procedures are taken. Because ITB needs surgical procedures, neurosurgeon or orthopedic surgeons have been involved so far. We neurologist, however, should at least know about ITB and its powerful effect against severe spasticity while we must be aware of dangerous situation due to overdose and secession of the baclofen.     

Functional outcome of intrathecal baclofen administration for severe spasticity

PURPOSE: To estimate the functional benefit in patients with severe spasticity treated with intrathecal baclofen infusion through an implantable pump and to stress the need for functional assessment of these patients with a functional scale. PATIENTS AND METHODS: Between 1999 and 2003, 22 patients with a long history of severe and disabling pharmaceutically intractable spasticity, underwent implantation of a pump for continuous intrathecal baclofen infusion. The patients were subdivided into two categories according to the aetiology of spasticity: 15 had Multiple Sclerosis and seven had suffered a Spinal Cord Injury at different levels (from C4 to T11). Clinical status was assessed with the Ashworth and Penn spasm scales. Functional benefits were evaluated with the Barthel index score and pain relief with a self-reported visual analogue pain scale. RESULTS: Postoperatively, all patients presented improvement in spasticity, reduction of spasm frequency, significant improvement in functional status, enhancement of life comfort and reduction of pain. CONCLUSION: Reduction of spasticity and spasms achieved with intrathecally delivered baclofen, leads to functional improvement and pain relief.     

Selective dorsal rhizotomy as an alternative to intrathecal baclofen pump replacement in GMFCS grades 4 and 5 children

Background

Conventionally, selective dorsal rhizotomy (SDR) has been reserved for ambulant children and implantation of intrathecal baclofen (ITB) pump for non-ambulant children with cerebral palsy. Rather than replacing the ITB pump in selected Gross Motor Function Classification System (GMFCS) grades 4 and 5 children, we elected to undertake SDR instead. We discuss the rationale and outcomes.

Objectives

To assess if children with severe spasticity treated with long-term ITB pump would benefit from SDR as alternative procedure to replacement of ITB pump.

Method

This study is a prospective review of ten children with severe spasticity. Indications for ITB pump replacement in 3/10 children were previous ITB pump infection and the remaining seven were nearing depletion of drug delivery system. Pre- and post-SDR mean modified Ashworth scores, assessment of urological function and survey of parent/carer satisfaction were undertaken.

Result

Mean Ashworth score reductions post-SDR in the lower limbs and upper limbs were 2.4 and 1.70, respectively. An improvement in urological function was also noticed in 27 % of patients. Overall, 90 % of parents/carers felt that functional outcome with SDR was improved compared with that of ITB.

Conclusion

SDR in comparison to ITB in this subgroup is cheaper, less intrusive by avoiding refills/replacement and found to be more effective than ITB in reducing spasticity and providing ease for nursing care. We therefore suggest that consideration should be given to SDR as an alternative in patients previously implanted with ITB systems complicated by infection or nearing end of battery life.

     

Low Rate of Intrathecal Baclofen Pump Catheter-Related Complications: Long-Term Study in Over 100 Adult Patients Associated With Reinforced Catheter

ObjectivesIntrathecal baclofen (ITB) is a cost-effective therapy for patients with severe spasticity. The most common complications are catheter-related complications (CRCs) including kinking/occlusion, blockage, migration, fracture, disconnection, and CSF leak. Our objective was to determine the CRC rate in a large cohort of adults with newly implanted ITB pump systems with polymer reinforced silicone catheters.Materials and MethodsThis is a retrospective study of a prospectively maintained database consisting of patients who had undergone implantation of ITB pump systems with Ascenda (Medtronic, Minneapolis) catheters from 2013 to 2020. Over this seven-year period, 141 patients underwent ITB pump system implantations; 126 of which had a minimum of one-year follow-up.ResultsThe 126 patients with a minimum of one year follow-up (average 43 month; range 12–89), had an average age of 51 years (63% male). Severe spasticity was due to spinal cord injury (38%), traumatic brain injury (15%), cerebral palsy (13%), multiple sclerosis (11%), stroke (10%), and other (13%). Nine (7.1%) CRCs occurred in 7 (5.6%) patients (median 6 mo. post-implant): 5 intrathecal catheter occlusions (range 3–52 months post-implant), two fractures in one patient (6 months), one disconnection at the catheter pump interface (2 months), and one due to kinking at 84 months No migrations occurred.ConclusionsReported CRCs have been high for ITB pump systems. Ours is the first large cohort, long-term study of CRCs related to reinforced catheters; additionally, our low CRC rate compares favorably to previously published data. Thus, implantation of reinforced catheters may be associated with a low CRC rate.     

GMFM 1 year after continuous intrathecal baclofen infusion

The purpose of this study was to assess whether there is an improvement in motor function in persons with cerebral palsy (CP) who have had a reduction of muscle tone by continuous intrathecal baclofen infusion. This was a prospective, open label, non-blinded case series without a control group, conducted at multiple centres. There were 31 subjects, aged 4–29 years. All had a pre-treatment mean lower extremity Ashworth scores of ≥?3 and a significant reduction in tone after a bolus injection of intrathecal baclofen (ITB) and received an implanted pump for continuous delivery of ITB. Motor function was assessed by the Gross Motor Function Measure (GMFM) prior to and 1 year following pump implantation. Significant improvement (p?<?0.05) in mean GMFM scores was seen in subjects <?8 years (mean change 4.1) and in those from 8–18 years (mean change 3.7) and in subjects with CP Classes 2 and 5 (mean changes 6.2 and 2.9). There was a statistically significant decrease (p?<?0.05) in Ashworth scores in CP classes 2–5. Subjects or their caregivers that completed a survey about perceived changes stated that motor control, positioning and endurance improved.     

Optimierte Therapie des spastischen Syndroms durch Kombination von intrathekalem Baclofen mit Botulinumtoxin

Intrathecal administration of baclofen has proved to be an effective treatment of spasticity related to CNS damage. Especially patients with spinal spasticity due to traumatic spinal cord injury or transverse myelitis showed a dramatic reduction of spasticity and improvement of their Ashworth scores. The results are, however, often disappointing in patients with muscular hypertension of the extensor muscles, which is frequently found in patients with multiple sclerosis or cerebral hypoxia. In the latter, using intrathecal baclofen may be restricted by serious side effects. Botulinumtoxin A is widely used in patients with various forms of dystonia. It has also been studied in spastic disorders, where local injections were valuable in relieving focal spasticity in hemiparetic patients and in infantile cerebral palsy. It is used only cautiously in severe paraspasticity. The case reports of 4 patients with incomplete and complete paraparesis due to spinal cord injury, neurodegenerative pyramidal disorder, and cerebral hypoxia demonstrate that a combination of intrathecal baclofen and botulinumtoxin A can improve clinical benefits and reduce side effects.     

Long–term intrathecal baclofen therapy in ambulatory patients with spasticity

Background Intrathecal baclofen (ITB) is an effective treatment for severe spasticity. In ambulatory patients with spasticity, it is possible that ITB treatment may compromise ambulatory function by unmasking underlying muscle weakness. This retrospective study is designed to determine the long–term ambulatory function in patients receiving ITB. Methods Thirty–six patients with severe spasticity previously screened for response to ITB were implanted with programmable pumps that allowed for continuous infusion of ITB. Patients were followed after implantation from 1 to 13 years. Results All 36 patients had decreased spasticity and retained ambulatory function. Three of the 36 patients eventually became paraplegic related to underlying disease progression. Conclusion ITB therapy may be used in selected ambulatory patients with spasticity and is not associated with loss of ambulatory function.     

Controlled study of the effects of continuous intrathecal baclofen infusion in non-ambulant children with cerebral palsy

Aim To measure changes in children with severe spastic cerebral palsy (CP) after continuous intrathecal baclofen (ITB) infusion over 18 months and to compare the results with those of a comparison group awaiting treatment. Method Thirty‐eight children with severe spastic CP considered suitable for ITB were assessed when first seen, just before insertion of an intrathecal pump, and 9 months and 18 months later. Eighteen children waited around 9 months for a pump (group 1: nine males, nine females; mean age 9y 11mo [SD 3y 7mo], nine in Gross Motor Function Classification System [GMFCS] level IV, nine in level V). This baseline period was used as a control for comparison with the first and second 9‐month periods after the pump for the remaining 20 children (group 2: 11 males, nine females; mean age 10y 2mo [SD 3y 1mo], nine in GMFCS level IV, 11 in level V). The main outcome measure was the Pediatric Evaluation of Disability Inventory (PEDI); other assessments were of function, ease of care, quality of life, and costs of new equipment. Results No significant change was found in the PEDI between group 1 while awaiting treatment and group 2 in the two periods afterwards, nor in the Lifestyle Assessment Questionnaire or the cost of new equipment. Significant changes were found in group 2 in the first 9 months according to the modified Ashworth score (difference between mean values for groups −1.7, standard error 0.58; p=0.008), Penn Spasm score (−1.3, 0.37; p=0.001), mean joint range of movement (8.3°, 2.8; p=0.005), and Caregiver Questionnaire (−19.7, 5.1; p=0.01), and in the second 9 months for the Modified Ashworth Scale score (−0.62, 0.12; p=0.001). Interpretation ITB in children with severe spastic CP over the first 18 months improves their quality of life in terms of comfort and ease of care. It has less effect on function, participation in society, or the overall cost of new equipment.     

Intrathecal baclofen therapy for severe spasticity: analysis on a series of 112 consecutive patients and future prospectives

Objective

Intrathecal baclofen therapy (ITB) is a well-known treatment for spasticity. Despite this fact, several topics have to be still discussed: new indications and screening tools, appropriate surgical timing and complicance avoidance.

Methods

A total of 112 consecutive patients all with a severe, progressive and refractory to medical therapy spasticity from different causes were treated using ITB, after a bolus test. Every patient was assessed by means of Modified Ashworth Scale (MAS), Penn spasm frequency scale (SFS) and Visual Analog Scale for pain. Since available, a Gait analysis was also performed.

Results

There were 63 males (56%) and 49 females (44%). Seventy-four (66%) had a quadriparesis, 34 (30.4%) had a paraparesis and 4 (3.6%) were hemiplegic. Among these patients 77 (68.7%) were non ambulatory, while 35 (31.3%) were ambulatory. These patients suffered from spasticity due to many different diseases.Mean follow-up was 55 months. The mean Modified Ashworth score decreased from 4.5 ± 0.5 preoperatively to 1.2 ± 0.4 on chronic intrathecal baclofen. Daily baclofen dose varied between 23 and 500 mcg. Drug-induced complications and catheter related problems occurred, respectively in 7 (6.3%) and 10 patients (8.9%).

Conclusions

Although ITB is a well known and good treatment option in the management of severe spasticity, because of the different goals and subgroups of patients treated, a variety of techniques are needed to evaluate the benefits of this therapy. New indications, effects of ITB on central nervous system and cognitive functions needs yet to be fully clarified.     

Measurement of the effect of a bolus dose of intrathecal baclofen by continuous measurement of force under fibreglass casts

Continuous intrathecal administration of baclofen with implanted programmable pump systems is recommended in the treatment of severe spasticity of cerebral origin. Prior to pump implantation, a baclofen bolus test (BBT) is used to assess the effectiveness of intrathecal baclofen using the modified Ashworth Scale (MAS) and Penn Spasm Frequency Scales (SFS). The result of a BBT may be difficult to interpret in patients with reduced joint mobility caused by contractures. The aim of this study was to apply a new spasticity measurement which would quantify and visualise the effect of a BBT in 10 patients with severe cerebral spasticity and contractures. Spasticity was recorded continuously by the measurement of force under circular fibreglass casts in 10 knee joint contractures. Force was recorded as net-torque by multiplying the force and distance between sensor and joint axis, thus allowing inter-individual comparison. MAS, SFS, and two three-hour time integrals of net-torque were determined before and after intrathecally administered baclofen. No significant changes in MAS (p = 0.1) and SFS (p = 0.07) were observed; however, a significant reduction of time integrals of net-torque after baclofen administration (p = 0.005) was found. The present study shows that the antispastic effect of intrathecally administered BBT can be quantitatively assessed and visualised using the described method. It also suggests that this method can be helpful in the assessment of the effectiveness of the BBT in patients with severe spasticity of cerebral origin and contractures. Received: 17 October 2001, Received in revised form: 15 March 2002, Accepted: 18 March 2002     

Intrathecal Baclofen for the Treatment of Intractable Spasticity of Spine or Brain Etiology

Objective. To determine the long‐term relief of spasticity and complication rates in patients who underwent placement of a programmable intrathecal baclofen pump for treatment of medically intractable spasticity of spine or brain etiology. Methods. Sixty‐two consecutive adult patients who underwent placement of a programmable pump were retrospectively reviewed. Results. Spasticity was clinically and statistically significantly decreased in all patients. Catheter‐related kinks, breaks, dislodgments, and disconnections were the most common complications followed by drug‐related effects, infections, and wound complications. Conclusions. Intrathecal baclofen is a very effective strategy for the relief of medically intractable spasticity of spine or brain etiology. Even though 36% of patients have required revisions, no patient has experienced any long‐term morbidity. Patients and their primary care givers have been pleased with the long‐term effects of this therapy upon quality of life.     

Intrathecal baclofen and motor function in cerebral palsy

Aim The aim of this retrospective analysis was to determine the impact of intrathecal baclofen (ITB) therapy on motor function in patients with cerebral palsy (CP). Method We studied 37 patients (18 males, 19 females) with CP treated with ITB (mean age at implant 13y 7mo, SD 7y). Eighteen patients were affected by spastic diplegia, 12 by spastic quadriplegia, six by dystonic quadriplegia, and one by hemidystonia. Nine participants were in Gross Motor Function Classification System (GMFCS) level II, 13 in level III, seven in level IV, and eight in level V. Motor function was assessed by the Gross Motor Function Measure (GMFM) before the treatment and 12 months after the implant. Results The collected data showed an increase in the total median GMFM score in the overall population (p<0.001) and in every GMFM dimension (p<0.05) except for dimension D (standing). The analysis by degree of impairment revealed that patients with severe impairment and those with mild to moderate impairment improved the total median GMFM score (p<0.001 and p<0.05 respectively). Analysis by age showed that the best improvements in GMFM scores were reached by patients younger than 18 years old (p<0.05). Spasticity and dystonia, assessed by means of the Ashworth and Barry–Albright Dystonia scales, significantly decreased 12 months after the implant (p<0.001 and p<0.05 respectively). Finally, a subjective questionnaire administered to patients/caregivers revealed an overall improvement in participants’ functional abilities. Interpretation The results suggest that ITB therapy is an effective treatment for managing spasticity and dystonia, and for improving motor function in children with CP.