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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Procedure: Paired Associative Stimulation; Procedure: Paired Associative Stimulation + Motor Imagery exercises; Procedure: Placebo Paired Associative Stimulation + Motor Imagery exercises

• Registration Number: NCT02779218
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-20
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	Paired Associative Stimulation	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
Sequence 3	Paired Associative Stimulation + Motor Imagery exercises	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
Sequence 1	Paired Associative Stimulation	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
Sequence 1	Placebo Paired Associative Stimulation + Motor Imagery exercises	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
Sequence 2	Placebo Paired Associative Stimulation + Motor Imagery exercises	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
Sequence 3	Paired Associative Stimulation	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
Sequence 3	Placebo Paired Associative Stimulation + Motor Imagery exercises	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
Sequence 1	Paired Associative Stimulation + Motor Imagery exercises	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
Sequence 2	Paired Associative Stimulation + Motor Imagery exercises	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

Primary Outcome Measures

Name	Time	Method
Effect of a reeducation session as assessed by amplitude of motor evoked potential	Week 3	25 minutes after stimulation

Secondary Outcome Measures

Name	Time	Method
Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential	Week 3	After the third stimulation
Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential	Week 3	After the third stimulation
Intensity curve as assessed by variation of intensity of motor evoked potential	Week 3	After the third stimulation
Motricity of upper limb recovering as assessed by Fugl Meyer Score	Week 3	After the third stimulation
Asymmetry index as assessed by resonance magnetic imaging	Day 1	At the inclusion visit

Trial Locations

Locations (1)

CHU Rangueil; 🇫🇷 Toulouse, France