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

July 28, 2020 updated by: University Hospital, Toulouse

Study of the Effects of the Combination of Motor Imagery Exercises and Transcranial Magnetic Stimulation (TMS) Type PAS in Patients After Hemiplegic Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • CHU Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: Paired Associative Stimulation
Patient with Paired Associative Stimulation only
Procedure: Paired Associative Stimulation + Motor Imagery exercises
Patient with Paired Associative Stimulation + Motor Imagery exercises
Procedure: Placebo Paired Associative Stimulation + Motor Imagery exercises
Patient with placebo Paired Associative Stimulation + Motor Imagery exercises
Experimental: 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
Procedure: Paired Associative Stimulation
Patient with Paired Associative Stimulation only
Procedure: Paired Associative Stimulation + Motor Imagery exercises
Patient with Paired Associative Stimulation + Motor Imagery exercises
Procedure: Placebo Paired Associative Stimulation + Motor Imagery exercises
Patient with placebo Paired Associative Stimulation + Motor Imagery exercises
Experimental: 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
Procedure: Paired Associative Stimulation
Patient with Paired Associative Stimulation only
Procedure: Paired Associative Stimulation + Motor Imagery exercises
Patient with Paired Associative Stimulation + Motor Imagery exercises
Procedure: Placebo Paired Associative Stimulation + Motor Imagery exercises
Patient with placebo Paired Associative Stimulation + Motor Imagery exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of a reeducation session as assessed by amplitude of motor evoked potential
Time Frame: Day 1
At the inclusion visit 25 minutes after stimulation
Day 1
Effect of a reeducation session as assessed by amplitude of motor evoked potential
Time Frame: Week 1
25 minutes after stimulation
Week 1
Effect of a reeducation session as assessed by amplitude of motor evoked potential
Time Frame: Week 2
25 minutes after stimulation
Week 2
Effect of a reeducation session as assessed by amplitude of motor evoked potential
Time Frame: Week 3
25 minutes after stimulation
Week 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
Time Frame: Week 1
After the first stimulation
Week 1
Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
Time Frame: Week 2
After the second stimulation
Week 2
Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
Time Frame: Week 3
After the third stimulation
Week 3
Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
Time Frame: Week 1
After the first stimulation
Week 1
Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
Time Frame: Week 2
After the second stimulation
Week 2
Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
Time Frame: Week 3
After the third stimulation
Week 3
Intensity curve as assessed by variation of intensity of motor evoked potential
Time Frame: Week 1
After the first stimulation
Week 1
Intensity curve as assessed by variation of intensity of motor evoked potential
Time Frame: Week 2
After the second stimulation
Week 2
Intensity curve as assessed by variation of intensity of motor evoked potential
Time Frame: Week 3
After the third stimulation
Week 3
Motricity of upper limb recovering as assessed by Fugl Meyer Score
Time Frame: Day 1
After inclusion visit
Day 1
Motricity of upper limb recovering as assessed by Fugl Meyer Score
Time Frame: Week 3
After the third stimulation
Week 3
Asymmetry index as assessed by resonance magnetic imaging
Time Frame: Day 1
At the inclusion visit
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Evelyne CASTEL-LACANAL, MD, physical medecine and readaption

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 389 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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