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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sequence 1

The patients will receive in order :

1. Paired Associative Stimulation
2. Paired Associative Stimulation + Motor Imagery exercises
3. Placebo Paired Associative Stimulation + Motor Imagery exercises

Group Type EXPERIMENTAL

Paired Associative Stimulation

Intervention Type PROCEDURE

Patient with Paired Associative Stimulation only

Paired Associative Stimulation + Motor Imagery exercises

Intervention Type PROCEDURE

Patient with Paired Associative Stimulation + Motor Imagery exercises

Placebo Paired Associative Stimulation + Motor Imagery exercises

Intervention Type PROCEDURE

Patient with placebo Paired Associative Stimulation + Motor Imagery exercises

Sequence 2

The patients will receive in order :

1. Paired Associative Stimulation + Motor Imagery exercises
2. Placebo Paired Associative Stimulation + Motor Imagery exercises
3. Paired Associative Stimulation

Group Type EXPERIMENTAL

Paired Associative Stimulation

Intervention Type PROCEDURE

Patient with Paired Associative Stimulation only

Paired Associative Stimulation + Motor Imagery exercises

Intervention Type PROCEDURE

Patient with Paired Associative Stimulation + Motor Imagery exercises

Placebo Paired Associative Stimulation + Motor Imagery exercises

Intervention Type PROCEDURE

Patient with placebo Paired Associative Stimulation + Motor Imagery exercises

Sequence 3

The patients will receive in order :

1. Placebo Paired Associative Stimulation + Motor Imagery exercises
2. Paired Associative Stimulation
3. Paired Associative Stimulation + Motor Imagery exercises

Group Type EXPERIMENTAL

Paired Associative Stimulation

Intervention Type PROCEDURE

Patient with Paired Associative Stimulation only

Paired Associative Stimulation + Motor Imagery exercises

Intervention Type PROCEDURE

Patient with Paired Associative Stimulation + Motor Imagery exercises

Placebo Paired Associative Stimulation + Motor Imagery exercises

Intervention Type PROCEDURE

Patient with placebo Paired Associative Stimulation + Motor Imagery exercises

Interventions

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Paired Associative Stimulation

Patient with Paired Associative Stimulation only

Intervention Type PROCEDURE

Paired Associative Stimulation + Motor Imagery exercises

Patient with Paired Associative Stimulation + Motor Imagery exercises

Intervention Type PROCEDURE

Placebo Paired Associative Stimulation + Motor Imagery exercises

Patient with placebo Paired Associative Stimulation + Motor Imagery exercises

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18-85 years
* Patients who have experienced a Stroke of more than one month
* Deficit out of the upper limb (Fugl Meyer member sup \<50/66)
* Presence of ECR muscle MEP
* Able to carry the motor imagery according to a test by measuring chronometer
* Patient who signed informed consent
* Subject affiliated to the social security system

Exclusion Criteria

* history of epilepsy or seizure
* MEP Lack of ECR
* Presence of a cons-indication for use of magnetic stimulation or MRI:

* Surgical Clips, metal sutures, staples, stent
* Osteosynthesis devices on the head or neck
* Pacemaker
* Implanted hearing aid
* Ocular foreign body, shrapnel, bullets
* Metal Worker
* Heart Valve, endovascular equipment
* Ventricular bypass valve
* Pace-maker or neurostimulator
* Claustrophobia
* incapable adult Patient, safeguard justice, guardianship or trusteeship
* Pregnant women and / or breastfeeding (because lack of data in the literature regarding the absence of foetotoxic effect)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No