Clinical trial NCT02779218: Combination of Motor Imagery Exercises and Brain Stimulation TMS Type PAS in Patients After Hemiplegic Stroke
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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hemiplegia
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Effect of a reeducation session as assessed by amplitude of motor evoked potential
timeFrame: Day 1
measure: Effect of a reeducation session as assessed by amplitude of motor evoked potential
timeFrame: Week 1
measure: Effect of a reeducation session as assessed by amplitude of motor evoked potential
timeFrame: Week 2
measure: Effect of a reeducation session as assessed by amplitude of motor evoked potential
timeFrame: Week 3
Secondary outcomes:
measure: Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
timeFrame: Week 1
measure: Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
timeFrame: Week 2
measure: Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
timeFrame: Week 3
measure: Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
timeFrame: Week 1
measure: Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
timeFrame: Week 2
measure: Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential
timeFrame: Week 3
measure: Intensity curve as assessed by variation of intensity of motor evoked potential
timeFrame: Week 1
measure: Intensity curve as assessed by variation of intensity of motor evoked potential
timeFrame: Week 2
measure: Intensity curve as assessed by variation of intensity of motor evoked potential
timeFrame: Week 3
measure: Motricity of upper limb recovering as assessed by Fugl Meyer Score
timeFrame: Day 1
measure: Motricity of upper limb recovering as assessed by Fugl Meyer Score
timeFrame: Week 3
measure: Asymmetry index as assessed by resonance magnetic imaging
timeFrame: Day 1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Rangueil
Study officials:
affiliation: physical medecine and readaption
name: Evelyne CASTEL-LACANAL, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.