rTMS to improve BCI control for upper‑limb rehabilitation after chronic stroke
ETUDE DE L'AMELIORATION DU CONTROLE DES INTERFACES CERVEAU-MACHINE PAR LA CONNECTIVITE FONCTIONNELLE ET LA STIMULATION MAGNETIQUE TRANSCRANIENNE REPETEE DANS LA REEDUCATION MOTRICE DU MEMBRE SUPERIEUR APRES UN ACCIDENT VASCULAIRE CHRONIQUE
This tests whether repeated transcranial magnetic stimulation (rTMS) helps people with chronic stroke use a brain–computer interface (BCI) to improve movement in their affected arm.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 1 site (Paris) |
| Trial ID | NCT06951035 on ClinicalTrials.gov |
What this trial studies
The trial enrolls adults with chronic single‑stroke upper‑limb motor deficits and visible finger extension to receive repeated transcranial magnetic stimulation combined with BCI‑guided motor training. Treatments are delivered at the Institut du Cerveau in Paris over multiple sessions while researchers record BCI control and clinical motor scores. Outcomes include changes in upper‑extremity Fugl‑Meyer scores and BCI performance measures to link physiological effects with functional gains. The protocol excludes patients with severe spasticity, major comprehension deficits, degenerative neurological disease, or skin/scalp lesions that prevent EEG or stimulation.
Who should consider this trial
Good fit: Ideal candidates are right‑handed adults aged 18–85, more than six months after a single stroke, with distal upper‑limb motor deficit (UE‑FMA < 53) and visible finger extension (mRC ≥ 2) who can give informed consent.
Not a fit: Patients with fixed severe spasticity (mAS = 4), absent finger extension, major language/comprehension impairment, degenerative neurological disease, recent botulinum toxin to the forearm/hand, craniectomy, or scalp/skin lesions preventing EEG/stimulation are unlikely to benefit or to be eligible.
Why it matters
Potential benefit: If successful, this approach could improve voluntary arm and hand movement and make BCI assistance more effective for people with chronic stroke.
How similar studies have performed: Previous rTMS trials have shown variable motor gains with limited evidence, and combining rTMS with BCI control is a relatively novel approach with promising but unproven results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Paris
- Institut du Cerveau — Paris, France (Recruiting)
Study contacts
- Study coordinator: Paolo BARTOLOMEO, MD, INSERM DR2
- Email: paolo.bartolomeo@upmc.fr
- Phone: +33 1 57 27 41 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.