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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02779218
Acronym
MIPAS
Enrollment
24
Registered
2016-05-20
Start date
2013-01-31
Completion date
2018-02-28
Last updated
2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Hemiplegia

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.

Interventions

Patient with Paired Associative Stimulation only

PROCEDUREPaired Associative Stimulation + Motor Imagery exercises

Patient with Paired Associative Stimulation + Motor Imagery exercises

PROCEDUREPlacebo Paired Associative Stimulation + Motor Imagery exercises

Patient with placebo Paired Associative Stimulation + Motor Imagery exercises

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Effect of a reeducation session as assessed by amplitude of motor evoked potentialDay 1At the inclusion visit 25 minutes after stimulation

Secondary

MeasureTime frameDescription
Intensity curve as assessed by variation of intensity of motor evoked potentialWeek 1After the first stimulation
Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potentialWeek 1After the first stimulation
Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potentialWeek 1After the first stimulation
Motricity of upper limb recovering as assessed by Fugl Meyer ScoreDay 1After inclusion visit
Asymmetry index as assessed by resonance magnetic imagingDay 1At the inclusion visit

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026