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

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779218
• Other study ID #: 12 389 02
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: February 2018

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Paired Associative Stimulation
Patient with Paired Associative Stimulation only
• Paired Associative Stimulation + Motor Imagery exercises
Patient with Paired Associative Stimulation + Motor Imagery exercises
• Placebo Paired Associative Stimulation + Motor Imagery exercises
Patient with placebo Paired Associative Stimulation + Motor Imagery exercises

Locations

Country	Name	City	State
France	CHU Rangueil	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of a reeducation session as assessed by amplitude of motor evoked potential	At the inclusion visit 25 minutes after stimulation	Day 1
Primary	Effect of a reeducation session as assessed by amplitude of motor evoked potential	25 minutes after stimulation	Week 1
Primary	Effect of a reeducation session as assessed by amplitude of motor evoked potential	25 minutes after stimulation	Week 2
Primary	Effect of a reeducation session as assessed by amplitude of motor evoked potential	25 minutes after stimulation	Week 3
Secondary	Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential	After the first stimulation	Week 1
Secondary	Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential	After the second stimulation	Week 2
Secondary	Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential	After the third stimulation	Week 3
Secondary	Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential	After the first stimulation	Week 1
Secondary	Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential	After the second stimulation	Week 2
Secondary	Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential	After the third stimulation	Week 3
Secondary	Intensity curve as assessed by variation of intensity of motor evoked potential	After the first stimulation	Week 1
Secondary	Intensity curve as assessed by variation of intensity of motor evoked potential	After the second stimulation	Week 2
Secondary	Intensity curve as assessed by variation of intensity of motor evoked potential	After the third stimulation	Week 3
Secondary	Motricity of upper limb recovering as assessed by Fugl Meyer Score	After inclusion visit	Day 1
Secondary	Motricity of upper limb recovering as assessed by Fugl Meyer Score	After the third stimulation	Week 3
Secondary	Asymmetry index as assessed by resonance magnetic imaging	At the inclusion visit	Day 1