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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Paired Associative Stimulation
Paired Associative Stimulation + Motor Imagery exercises
Placebo Paired Associative Stimulation + Motor Imagery exercises
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Hemiplegia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU Rangueil

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Arm Description

The patients will receive in order : Paired Associative Stimulation Paired Associative Stimulation + Motor Imagery exercises Placebo Paired Associative Stimulation + Motor Imagery exercises

The patients will receive in order : Paired Associative Stimulation + Motor Imagery exercises Placebo Paired Associative Stimulation + Motor Imagery exercises Paired Associative Stimulation

The patients will receive in order : Placebo Paired Associative Stimulation + Motor Imagery exercises Paired Associative Stimulation Paired Associative Stimulation + Motor Imagery exercises

Outcomes

Primary Outcome Measures

Effect of a reeducation session as assessed by amplitude of motor evoked potential
At the inclusion visit 25 minutes after stimulation
Effect of a reeducation session as assessed by amplitude of motor evoked potential
25 minutes after stimulation
Effect of a reeducation session as assessed by amplitude of motor evoked potential
25 minutes after stimulation
Effect of a reeducation session as assessed by amplitude of motor evoked potential
25 minutes after stimulation

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2016
Last Updated
July 28, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02779218
Brief Title
Combination of Motor Imagery Exercises and Brain Stimulation TMS Type PAS in Patients After Hemiplegic Stroke
Acronym
MIPAS
Official Title
Study of the Effects of the Combination of Motor Imagery Exercises and Transcranial Magnetic Stimulation (TMS) Type PAS in Patients After Hemiplegic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Hemiplegia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
The patients will receive in order : Paired Associative Stimulation Paired Associative Stimulation + Motor Imagery exercises Placebo Paired Associative Stimulation + Motor Imagery exercises
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
The patients will receive in order : Paired Associative Stimulation + Motor Imagery exercises Placebo Paired Associative Stimulation + Motor Imagery exercises Paired Associative Stimulation
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
The patients will receive in order : Placebo Paired Associative Stimulation + Motor Imagery exercises Paired Associative Stimulation Paired Associative Stimulation + Motor Imagery exercises
Intervention Type
Procedure
Intervention Name(s)
Paired Associative Stimulation
Intervention Description
Patient with Paired Associative Stimulation only
Intervention Type
Procedure
Intervention Name(s)
Paired Associative Stimulation + Motor Imagery exercises
Intervention Description
Patient with Paired Associative Stimulation + Motor Imagery exercises
Intervention Type
Procedure
Intervention Name(s)
Placebo Paired Associative Stimulation + Motor Imagery exercises
Intervention Description
Patient with placebo Paired Associative Stimulation + Motor Imagery exercises
Primary Outcome Measure Information:
Title
Effect of a reeducation session as assessed by amplitude of motor evoked potential
Description
At the inclusion visit 25 minutes after stimulation
Time Frame
Day 1
Title
Effect of a reeducation session as assessed by amplitude of motor evoked potential
Description
25 minutes after stimulation
Time Frame
Week 1
Title
Effect of a reeducation session as assessed by amplitude of motor evoked potential
Description
25 minutes after stimulation
Time Frame
Week 2
Title
Effect of a reeducation session as assessed by amplitude of motor evoked potential
Description
25 minutes after stimulation
Time Frame
Week 3
Secondary Outcome Measure Information:
Title
Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
Description
After the first stimulation
Time Frame
Week 1
Title
Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
Description
After the second stimulation
Time Frame
Week 2
Title
Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
Description
After the third stimulation
Time Frame
Week 3
Title
Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
Description
After the first stimulation
Time Frame
Week 1
Title
Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
Description
After the second stimulation
Time Frame
Week 2
Title
Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
Description
After the third stimulation
Time Frame
Week 3
Title
Intensity curve as assessed by variation of intensity of motor evoked potential
Description
After the first stimulation
Time Frame
Week 1
Title
Intensity curve as assessed by variation of intensity of motor evoked potential
Description
After the second stimulation
Time Frame
Week 2
Title
Intensity curve as assessed by variation of intensity of motor evoked potential
Description
After the third stimulation
Time Frame
Week 3
Title
Motricity of upper limb recovering as assessed by Fugl Meyer Score
Description
After inclusion visit
Time Frame
Day 1
Title
Motricity of upper limb recovering as assessed by Fugl Meyer Score
Description
After the third stimulation
Time Frame
Week 3
Title
Asymmetry index as assessed by resonance magnetic imaging
Description
At the inclusion visit
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelyne CASTEL-LACANAL, MD
Organizational Affiliation
physical medecine and readaption
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rangueil
City
Toulouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32414294
Citation
Brihmat N, Tarri M, Gasq D, Marque P, Castel-Lacanal E, Loubinoux I. Cross-Modal Functional Connectivity of the Premotor Cortex Reflects Residual Motor Output After Stroke. Brain Connect. 2020 Jun;10(5):236-249. doi: 10.1089/brain.2020.0750. Epub 2020 Jun 11.
Results Reference
result

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

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