Clinical Trial: Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment: Double Blinded Comparison Between Botulinum Toxin and Baclofen.

Brief Summary: Stroke is the first cause of motor impairment and disability in adults. Then the main objective of rehabilitation during the first six months following stroke is to facilitate motor recovery. Many post-stroke hemiplegics develop spasticity which is responsible for an increase of disability. Then antispastic drugs are frequently prescribed to the patients even during the post-stroke recovery phase. Until recently most of french patients were treated by oral tablets of baclofen. Now the number of patients receiving intramuscular injections of botulinum A toxin is increasing. However in the literature, these drugs have been tested in post-stroke spasticity during the chronicle phase, after the sixth month and their action on motor recovery remain largely unknown. Then it is necessary to evaluate more accurately the effects of its drugs on motor recovery. The main criterion of its study is the time course of Fugl-Meyer Motor Assessment (FMA). Spastic patients with a single stroke, since less than two months, will be included in the try. They receive at the same time oral tablets for five months and intramuscular injections. Patients are randomized in three arms planned with a distribution balanced by group of 5 patients with a 2 -2- 1 model: botulinum toxin and placebo baclofen (120 patients), oral baclofen and placebo botulinum toxin (120 patients), placebo baclofen and placebo botulinum toxin (60 patients). The FMA score will be assessed before treatment start, one month and three months later. Spasticity, functional abilities, capacity in the activities of daily life, pain and quality of life will be also assessed during the study with Tardieu score, Rivermead Motor Assessment scale, Barthel index, Rankin score, Visual Analogic Scale and Reintegration to Normal Life Index respectively. A positive difference of 12 points in the time course of FMA in the botulinum toxin group in comparison with the baclofen group will be considered as the minimum relevant effect. 300 p

Detailed Summary:

Background: Stroke is the first cause of motor impairment and disability in adults. 80% of post-stroke survivors have a motor weakness resulting in hemiplegia. Post-stroke patients partially recover from their motor impairments . These patients reach their maximum motor score round the first 20 weeks. In all cases, motor recovery period is considered completed beyond the sixth month. There is a consensus of epidemiological studies and of more fundamental works on brain plasticity, for the positive effect of rehabilitation on post stroke motor recovery. Then the main objective of rehabilitation during the first six months following stroke is to facilitate motor recovery.

There are many arguments in animals and humans for the pharmacological modulation of post-stroke motor recovery. In animals, the experimental data suggesting efficacy of amphetamine in motor recovery after brain injury, are numerous. The administration of amphetamine in rats dramatically improves motor recovery after brain injury. This action appears to be related to the α noradrenergic activity of amphetamines and their properties of norepinephrine precursor. In contrast molecules that reduce the release of norepinephrine, which increase its metabolism, or blocking its post-synaptic effects such as gabaergic drugs or clonidine have a deleterious effect on motor recovery after brain injury.

In humans, the results of studies concerning the action of amphetamine are much more contrasted. A study in functional imaging has shown that a single dose of methylphenidate was able to modulate brain plasticity in post-stroke patients by increasing the activity of substitute neural networks in the lesioned hemisphere. However, if some clinical studies confirm the positive result, others at the opposite show no behavioral effect on recovery as compared to placebo g
Sponsor: University Hospital, Toulouse

Current Primary Outcome: Motor recovery with time course of Fugl-Meyer Assessment scale [ Time Frame: month 3 ]

A positive difference of 12 points in the time of course of Fugl-Meyer motor Assessment scale (FMA) from inclusion to the third month, between the results obtained in the botulinum toxin group and those of the baclofen group will be considered as the minimum relevant effect.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • none inferiority of motor recovery with time course of Fugl-Meyer Assessment scale [ Time Frame: month 3 ]
    A none inferiority of the FMA time course between the results of the botulinum toxin group and the placebo group will be researched.
  • Spasticity with Tardieu scale [ Time Frame: Month 1 and 3 ]
    A comparison of efficacy of the two treatments on spastic symptoms using Tardieu scale.
  • Function with Rivermead Motor Assessment score, [ Time Frame: month 3 ]
    Functional impact of early treatment of post-stroke spasticity: comparison of changes in the Rivermead Motor Assessment score during the three months of protocol between all groups.
  • Quality of life : Reintegration to Normal Life Index [ Time Frame: month 3 ]
  • Pain : Visual Analogic Scale [ Time Frame: Month 1 and 3 ]


Original Secondary Outcome:

  • Motor recovery with time course of Fugl-Meyer Assessment scale [ Time Frame: month 3 ]
    A none inferiority of the FMA time course between the results of the botulinum toxin group and the placebo group will be researched.
  • Spasticity with Tardieu scale [ Time Frame: Month 1 and 3 ]
    A comparison of efficacy of the two treatments on spastic symptoms using Tardieu scale.
  • Function with Rivermead Motor Assessment score, [ Time Frame: month 3 ]
    Functional impact of early treatment of post-stroke spasticity: comparison of changes in the Rivermead Motor Assessment score during the three months of protocol between all groups.
  • Quality of life : Reintegration to Normal Life Index [ Time Frame: month 3 ]
  • Pain : Visual Analogic Scale [ Time Frame: Month 1 and 3 ]


Information By: University Hospital, Toulouse

Dates:
Date Received: May 5, 2015
Date Started: April 2015
Date Completion: September 2017
Last Updated: December 13, 2016
Last Verified: December 2016