Combination of Motor Imagery Exercises and Brain Stimulation TMS Type PAS in Patients After Hemiplegic Stroke "MIPAS"

Recruiting

Phase N/A Results N/A

Trial Description

Strokes represent, in industrialized countries the leading cause of acquired motor disability in adults older than 40. Stroke is responsible for France from 150 000 to 200 000 new cases of hemiplegia each year. These patients will see their deficit to improve during the first 6 months after stroke. This recovery is largely based on brain plasticity mechanisms and the rehabilitation has as main objective to optimize these mechanisms. However, only 20% of patients hospitalized in a rehabilitation sector recover a functional upper limb. This lack of functionality is not only due to overall strength gap but also to the predominance of this gap on the extension movements of the wrist and fingers.
Meanwhile, work on brain plasticity helped develop new techniques of non-invasive brain stimulation (Non-invasive Brain Stimulation, NIBS) as the model of coupled stimulations (Paired Associative Stimulation, PAS) for modulating way over effective brain plasticity. In previous studies, the investigators have shown over a 30 minutes session lasting facilitation (60mn) and specific motor evoked potential (MEP) of the Extensor Carpi Radialis (ECR). Several studies showed an adjuvant effect when GSIN were associated with learning of a motor task. For PAS, some studies have shown a greater facilitation when the latter is associated with muscle contraction.
The motor imagery (MI) is imagining a movement without realizing it, it is based on mechanisms similar to those of the real movement. This technique also showed its effects as an adjuvant therapy in hemiplegic patients, however, they remain lower than those obtained after a motor drive. Its use in patients with no motor makes its uniqueness and strength.

Conditions

Interventions

  • Paired Associative Stimulation Procedure
    Intervention Desc: Patient with Paired Associative Stimulation only
    ARM 1: Kind: Experimental
    Label: Sequence 1
    Description: The patients will receive in order : Paired Associative Stimulation Paired Associative Stimulation + Motor Imagery exercises Placebo Paired Associative Stimulation + Motor Imagery exercises
    ARM 2: Kind: Experimental
    Label: Sequence 2
    Description: The patients will receive in order : Paired Associative Stimulation + Motor Imagery exercises Placebo Paired Associative Stimulation + Motor Imagery exercises Paired Associative Stimulation
    ARM 3: Kind: Experimental
    Label: Sequence 3
    Description: The patients will receive in order : Placebo Paired Associative Stimulation + Motor Imagery exercises Paired Associative Stimulation Paired Associative Stimulation + Motor Imagery exercises
  • Paired Associative Stimulation + Motor Imagery exercises Procedure
    Intervention Desc: Patient with Paired Associative Stimulation + Motor Imagery exercises
    ARM 1: Kind: Experimental
    Label: Sequence 1
    Description: The patients will receive in order : Paired Associative Stimulation Paired Associative Stimulation + Motor Imagery exercises Placebo Paired Associative Stimulation + Motor Imagery exercises
    ARM 2: Kind: Experimental
    Label: Sequence 2
    Description: The patients will receive in order : Paired Associative Stimulation + Motor Imagery exercises Placebo Paired Associative Stimulation + Motor Imagery exercises Paired Associative Stimulation
    ARM 3: Kind: Experimental
    Label: Sequence 3
    Description: The patients will receive in order : Placebo Paired Associative Stimulation + Motor Imagery exercises Paired Associative Stimulation Paired Associative Stimulation + Motor Imagery exercises
  • Placebo Paired Associative Stimulation + Motor Imagery exercises Procedure
    Intervention Desc: Patient with placebo Paired Associative Stimulation + Motor Imagery exercises
    ARM 1: Kind: Experimental
    Label: Sequence 1
    Description: The patients will receive in order : Paired Associative Stimulation Paired Associative Stimulation + Motor Imagery exercises Placebo Paired Associative Stimulation + Motor Imagery exercises
    ARM 2: Kind: Experimental
    Label: Sequence 2
    Description: The patients will receive in order : Paired Associative Stimulation + Motor Imagery exercises Placebo Paired Associative Stimulation + Motor Imagery exercises Paired Associative Stimulation
    ARM 3: Kind: Experimental
    Label: Sequence 3
    Description: The patients will receive in order : Placebo Paired Associative Stimulation + Motor Imagery exercises Paired Associative Stimulation Paired Associative Stimulation + Motor Imagery exercises

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Supportive Care
  • Endpoint: Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Effect of a reeducation session as assessed by amplitude of motor evoked potential Day 1 No
Secondary Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential Week 1 No
Secondary Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential Week 1 No
Secondary Intensity curve as assessed by variation of intensity of motor evoked potential Week 1 No
Secondary Motricity of upper limb recovering as assessed by Fugl Meyer Score Day 1 No
Secondary Asymmetry index as assessed by resonance magnetic imaging Day 1 No

Sponsors