Philippe Gallien

Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: Results of a multicenter prospective study†‡§

Electrostimulation is an established therapeutic option for neurogenic urinary disorders. The aim of this study was to investigate the efficacy of the noninvasive technique of transcutaneous posterior tibial nerve stimulation (TPTNS) in patients with multiple sclerosis (MS) and troublesome symptoms of an overactive bladder (OAB).

Placebo controlled, randomised, double blind study of the effects of botulinum A toxin on detrusor sphincter dyssynergia in multiple sclerosis patients

Objective: The purpose of the study was to evaluate the efficacy and safety of botulinum A toxin in the treatment of detrusor sphincter dyssynergia in multiple sclerosis patients. Methods: This was a multicentre, placebo controlled, randomised, double blind study. Patients with chronic urinary retention were included if they had post-voiding residual urine volume between 100 and 500 ml. They received a single transperineal injection of either botulinum A toxin (100 U Allergan) or placebo in the sphincter and also 5 mg slow release alfuzosin bid over 4 months. Main endpoint was post-voiding residual urine volume assessed 1 month after injection. Follow up duration was 4 months. Statistical analysis was performed using a sequential method, the triangular test. Results: The study was stopped after the fourth analysis (86 patients had been included: placebo: 41, botulinum A toxin: 45). At inclusion, there was no significant difference between groups whichever variable was considered. Mean (standard deviation) post-voiding residual urine volume was 217 (96) and 220 (99) ml in placebo and botulinum A toxin groups, respectively. One month later, post-voiding residual urine volume was 206 (145) and 186 (158) ml (p = 0.45) in placebo and botulinum A toxin groups, respectively. However, compared to placebo, botulinum A toxin significantly increased voiding volume (+54%, p = 0.02) and reduced pre-micturition (−29%, p = 0.02) and maximal (−21%, p = 0.02) detrusor pressures. Other secondary urodynamic endpoints and tolerance were similar in the two groups. Conclusions: In multiple sclerosis patients with detrusor sphincter dyssynergia, a single injection of botulinum A toxin (100 U Allergan) does not decrease post-voiding residual urine volume.

Restoration of gait by functional electrical stimulation for spinal cord injured patients

In this clinical study, we report the results of functional electrical stimulation for the ambulation of paraplegic patients without long leg braces (LLB), according to the Parastep approach. Of 13 SCI patients with complete neurological lesions included in this trial, 12 progressed to independent ambulation with the aid of the Parastep. The average walking distance was 76 m, with a maximum of 350 m, and the mean speed 0.2 ms-1. Compared to the situation with long leg braces, which in fact are given up by most paraplegic patients, long term home use seems to be much more important. Tolerance of this method is satisfactory. The psychological benefits of the device are remarkable. From this experience, it is concluded that this method is valuable for the restoration of standing and walking in the long term management of spinal cord injury patients.

Magnetoencephalography in stroke: a 1‐year follow‐up study

Recovery after stroke is closely linked to cerebral plasticity. Magnetoencephalography (MEG) is a non‐invasive technique, which allows location of cerebral cells activities. In the present work, a cohort of patients has been studied with MEG. Twelve patients with a recent ischemic or hemorragic stroke were included as soon as possible after onset of stroke. Neurologic assessment, including standard neurologic examination, functional independence measure (FIM) and Orgogozos scale was performed for 1 year in addition to a study of the somatosensory evoked field (SEF) using a 37‐channel Biomagnetometer system. No response could be recorded in five patients at the first SEF exploration. In three cases, no response was ever recorded during the study. All these patients had a bad recovery. The location of the SEF sources was always in the normal non‐infarcted cortex of the postcentral gyrus. Sensory recovery seemed to be linked to the reorganization of the persistent functional cortex, which was a limiting factor for recovery. These observations confirm the experimental results obtained in animal models. After stroke it can be assumed that in the case of incomplete lesion, an intensive sensory peripheral stimulation could maximize the use of residual sensory function and then contribute to improve the sensory deficit. In case of total sensory loss other techniques have to be used, such as visual monitoring of hand activity in order to improve hand function.

A French observational study of botulinum toxin use in the management of children with cerebral palsy: BOTULOSCOPE

BACKGROUND Dystonia and spasticity are common symptoms in children with Cerebral Palsy (CP), whose management is a challenge to overcome in order to enable the harmonized development of motor function during growth. AIM To describe botulinum toxin A (BTX-A) use and efficacy as a treatment of focal spasticity in CP children in France. METHODS This prospective observational study included 282 CP children mostly administered according to French standards with BTX-A in lower limbs. Realistic therapeutic objectives were set with parents and children together before treatment initiation and assessed using the Visual Analogue Scale (VAS). Child management was recorded and the efficacy of injections was assessed during a 12-month follow-up period by physicians (Modified Ashworth Scale, joint range of motion, Physician Rating Scale, Gillette Functional Assessment Questionnaire and Gross Motor Function Measure-66) and by patients/parents (Visual Analogue Scale). RESULTS BTX-A treatment was administered in different muscle localizations at once and at doses higher than those recommended by the French Health Authorities. Children were treated in parallel by physiotherapy, casts and ortheses. Injections reduced spasticity and improved joint range of motion, gait pattern and movement capacity. Pain was reduced after injections. BTX-A administration was safe: no botulism-like case was reported. The log of injected children who were not included in the study suggested that a large population could benefit from BTX-A management. CONCLUSIONS We showed here the major input of BTX-A injections in the management of spasticity in CP children. The results are in favor of the use of BTX-A as conservative safe and efficient treatment of spasticity in children, which enables functional improvement as well as pain relief.

Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial

Objective: Our aim was to assess the usefulness of cranberry extract in multiple sclerosis (MS) patients suffering from urinary disorders. Methods: In total, 171 adult MS outpatients with urinary disorders presenting at eight centers were randomized (stratification according to center and use of clean intermittent self-catheterization) to cranberry versus placebo in a 1-year, prospective, double-blind study that was analyzed using a sequential method on an intent-to-treat basis. An independent monitoring board analyzed the results of the analyses each time 40 patients were assessed on the main endpoint. Cranberry extract (36 mg proanthocyanidins per day) or a matching placebo was taken by participants twice daily for 1 year. The primary endpoint was the time to first symptomatic urinary tract infection (UTI), subject to validation by a validation committee. Results: The second sequential analyses allowed us to accept the null hypothesis (no difference between cranberry and placebo). There was no difference in time to first symptomatic UTI distribution across 1 year, with an estimated hazard ratio of 0.99, 95% CI [0.61, 1.60] (p = 0.97). Secondary endpoints and tolerance did not differ between groups. Conclusion: Taking cranberry extract versus placebo twice a day did not prevent UTI occurrence in MS patients with urinary disorders. Trial Registration NCT00280592.

Intermittent catheterization acceptance test (I-CAT): A tool to evaluate the global acceptance to practice clean intermittent self-catheterization

In certain cases, a patients anxiety, fear, or misconceptions can represent significant obstacles to the learning of Clean Intermittent Self Catheterization (CISC), and little is known about these psychological barriers. The aim of the present study is thus to construct and validate an “Intermittent Catheterization Acceptance Test (I‐CAT)” to evaluate the psychological acceptance of CISC.

Effects of a 6-month self-rehabilitation programme in addition to botulinum toxin injections and conventional physiotherapy on limitations of patients with spastic hemiparesis following stroke (ADJU-TOX): protocol study for a randomised controlled, investigator blinded study

Introduction Home-based self-rehabilitation programmes combined with botulinum toxin injections (BTIs) appear to be a relevant approach to increase the recommended intensive rehabilitation of patients with spasticity following a stroke. The literature highlights a lack of evidence of beneficial effects of this adjuvant therapy to reduce limitations of patients with stroke. The aim of this study is to assess the effects of a 6-month self-rehabilitation programme in adjunction to BTI, in comparison with BTI alone, to reduce limitations of patients with spasticity following a stroke. Methods and analysis 220 chronic patients will participate to this multicentre, prospective, randomised, controlled, assessor blinded study. All patients will benefit from two successive BTI (3 months apart), and patients randomised in the self-rehabilitation group will perform in adjunction 6 months of self-rehabilitation at home. All patients continue their conventional physiotherapy. The main outcome is the primary treatment goal (PTG), which will be determined jointly by the patient and the medical doctor using Goal Attainment Scaling. Impairments and functions, quality of life, mood and fatigue will be assessed. Botulinum toxin will be injected into the relevant muscles according to the PTG. Patients in the self-rehab group will be taught the self-rehabilitation programme involving respectively 10 min of stretching, 10 min of strengthening and 10 min of task-oriented exercises, corresponding to their PTG. Compliance to the self-rehabilitation programme will be monitored. Ethics and dissemination Patients will sign written informed consent. Ethical approval was obtained from ethics committee. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients. Trial registration number NCT02944929.