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

NCT02779218 | Completed

• 1 other identifier: 12 389 02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Hemiplegia

Outcome Measures

Primary Outcomes (4)

• Effect of a reeducation session as assessed by amplitude of motor evoked potential

  At the inclusion visit 25 minutes after stimulation

  Day 1

• Effect of a reeducation session as assessed by amplitude of motor evoked potential

  25 minutes after stimulation

  Week 1

• Effect of a reeducation session as assessed by amplitude of motor evoked potential

  25 minutes after stimulation

  Week 2

• Effect of a reeducation session as assessed by amplitude of motor evoked potential

  25 minutes after stimulation

  Week 3

Secondary Outcomes (12)

• Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

  Week 1

• Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

  Week 2

• Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

  Week 3

• Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

  Week 1

• Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

  Week 2

Study Arms (3)

Sequence 1

EXPERIMENTAL

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; Procedure: Paired Associative Stimulation + Motor Imagery exercises; Procedure: Placebo Paired Associative Stimulation + Motor Imagery exercises

Sequence 2

EXPERIMENTAL

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; Procedure: Paired Associative Stimulation + Motor Imagery exercises; Procedure: Placebo Paired Associative Stimulation + Motor Imagery exercises

Sequence 3

EXPERIMENTAL

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; Procedure: Paired Associative Stimulation + Motor Imagery exercises; Procedure: Placebo Paired Associative Stimulation + Motor Imagery exercises

Interventions

Paired Associative Stimulation PROCEDURE

Patient with Paired Associative Stimulation only

Sequence 1; Sequence 2; Sequence 3

Placebo Paired Associative Stimulation + Motor Imagery exercises PROCEDURE

Patient with placebo Paired Associative Stimulation + Motor Imagery exercises

Sequence 1; Sequence 2; Sequence 3

Paired Associative Stimulation + Motor Imagery exercises PROCEDURE

Patient with Paired Associative Stimulation + Motor Imagery exercises

Sequence 1; Sequence 2; Sequence 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Rangueil

Toulouse, France

Location

Related Publications (2)

• Brihmat, N.; Castel-Lacanal, E.; Tarri, M.; Lepage, B.; Montane, E.; Cormier, C.; de Boissezon, X.; Gasq, D.; Loubinoux, I.; Marque, P. Motor Imagery and Paired Associative Stimulation in Poststroke Rehabilitation: Dissociating Motor and Electrophysiological Effects. Appl. Sci. 2023, 13, 6063

  RESULT

• 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.

  PMID: 32414294 RESULT

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Evelyne CASTEL-LACANAL, MD

  physical medecine and readaption

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: May 20, 2016
• Study Start: January 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 8, 2026

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)