Status:
NOT_YET_RECRUITING
Impact of rTMS on BCI Control in Upper Limb Motor Rehabilitation of Patients With Chronic Stroke
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Chonic Stroke Patients With Motor Impairment of Upper Limb
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Cerebrovascular accidents (strokes) are a major public health issue. Stroke is the 3rd leading cause of death and the leading cause of disability and loss of autonomy. In France, there are currently 1...
Eligibility Criteria
Inclusion
- Single Stroke older than 6 months
- Distal motor deficit of the upper limb (UE-FMA score \< 53) with visible extension of the fingers (Medical Research Council (mRC) score ≥ 2)
- Right-handed
- Between 18 and 85 years of age
- Having given their written consent
Exclusion
- Patient under tutorship or guardianship, under safeguard of justice, deprived of liberty, pregnant or breast feeding women
- Life-threatening pathologies or compromising follow-up during the study period
- Trouble of understanding : score below 12/15 in the Boston Diagnostic Aphasia Examination (BDAE) order execution test
- Fixed spasticity of finger or carpal flexors (mAS score = 4) or botulinum toxin injection less than 12 weeks old in the forearm or hand
- History of degenarative neurological pathology or craniectomy
- Deficient upper limb skin lesion preventing use of mucle stimulation
- Skin lesion of the scalp preventing EEG placement
- Participation in biomedical therapeutic research that may affect the recovery of the deficient hand during the study
- Patient who has previously participated in a therapeutic study rTMS (excluding single shock) or a BCI
- Patient who does not wish to be informed of a brain abnormality discovered accidentally on MRI
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06951035
Start Date
May 1 2025
End Date
April 1 2029
Last Update
April 30 2025
Active Locations (1)
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1
Institut du Cerveau
Paris, France, 75013