Neuromodulation for motor recovery after stroke
CEREBELLO-MOTOR NEUROMODULATION AFTER STROKE
This study is testing whether a new brain stimulation technique can help stroke patients recover their movement better than a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT06599931 on ClinicalTrials.gov |
What this trial studies
The CERSTIM study investigates the effects of transcranial alternating current stimulation (tACS) on the cerebello-motor network in stroke patients. Using a crossover design, the study tests two gamma band frequencies and a placebo to assess their impact on motor recovery. Behavioral data, functional MRI, and electroencephalography will be utilized to understand the mechanisms of tACS. Healthy participants will also be included to provide comparative insights.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced an ischemic stroke or intraparenchymal hematoma more than six months prior, with specific motor deficits.
Not a fit: Patients with total paralysis of the affected hand or contraindications to MRI and tACS will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance motor recovery in stroke patients, improving their quality of life.
How similar studies have performed: While neuromodulation techniques have shown promise in other studies, this specific approach using tACS in the cerebello-motor network is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
PATIENTS Inclusion Criteria: * Male or female aged 18 years or older on the day of inclusion. * Affiliated with a social security system, Universal Health Coverage (CMU), or any equivalent scheme. * Ischemic stroke or intraparenchymal hematoma that occurred more than 6 months ago, with no upper time limit. * Motor deficit of the upper limb confirmed by the ARAT scale, with the ability to grip and press on a tablet. * stroke lesion not affecting the motor cortex in the hand knob area. Exclusion Criteria: \-- Pregnant and breastfeeding women * Total paralysis of the affected hand * Conditions that are life-threatening or could compromise follow-up during the study period * Contraindications to MRI and tACS (ferromagnetic surgical clips, ocular implants, intraocular or nervous system metallic foreign bodies, implants or metallic objects likely to concentrate the radiofrequency field, cochlear implants, brain or cardiac stimulators, presence of a craniotomy scar) * Participation in another biomedical study focused on motor or overall recovery during the same period, or current exclusion period from another biomedical study HEALTHY Inclusion Criteria: * Male or female aged 18 years or older on the day of inclusion. * Affiliated with a social security system, Universal Health Coverage (CMU), or any equivalent scheme. Non inclusion criteria \-- Pregnant and breastfeeding women * Conditions that are life-threatening or could compromise follow-up during the study period * Contraindications to MRI and tACS (ferromagnetic surgical clips, ocular implants, intraocular or nervous system metallic foreign bodies, implants or metallic objects likely to concentrate the radiofrequency field, cochlear implants, brain or cardiac stimulators, presence of a craniotomy scar) * Participation in another biomedical study during the same period, or current exclusion period from another biomedical study
Where this trial is running
Paris and 1 other locations
- ICM_ Institut du Cerveau et de la Moelle épinière, Hôpital Pitié, 47 Bd de l'Hôpital — Paris, France (Recruiting)
- ToNIC - Toulouse neuro Imaging center (Inserm)Pavillon Baudot — Toulouse, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Charlotte ROSSO, MD PHD — Institut National de la Santé Et de la Recherche Médicale, France
- Study coordinator: Charlotte ROSSO, MD PhD
- Email: charlotte.rosso@aphp.fr
- Phone: +33142162103
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.