Combining non-invasive brain and spinal cord stimulation to improve arm and hand function
Synergistic Potential of Non-invasive Brain and Spinal Cord Stimulation for Improving Sensorimotor and Cognitive Functions After Neurological Injury
This study tests whether pairing non-invasive brain stimulation (tDCS) with spinal cord stimulation (tSCS) during a cognitive-motor task can improve sensorimotor and cognitive-motor function in people with cervical spinal cord injury or stroke compared with each stimulation alone or sham.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre National de la Recherche Scientifique, France Academic / other |
| Locations | 2 sites (Bordeaux and 1 other locations) |
| Trial ID | NCT07334977 on ClinicalTrials.gov |
What this trial studies
This randomized interventional Phase 2 study compares combined transcranial direct current stimulation (tDCS) plus transcutaneous spinal cord stimulation (tSCS) against each stimulation alone and a sham condition while participants perform a cognitive-motor task. Participants include people with cervical spinal cord injury, people after stroke, and able-bodied controls, with immediate sensorimotor and cognitive-motor outcomes measured before and after sessions. The protocol also collects anatomical MRI, functional MRI, and neurophysiological data to explore markers that could optimize or predict response. The focus is on characterizing any short-term synergistic effects and informing future rehabilitation strategies.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) who are medically stable with cervical spinal cord injury (AIS A–D) or who had a stroke more than three weeks ago, can give informed consent, and meet local social security/coverage requirements, with able-bodied volunteers also eligible.
Not a fit: People with a history of epilepsy or seizures, active skin wounds or other excluded chronic conditions, or those with non-cervical injuries are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined stimulation approach could produce faster or larger improvements in arm movement and cognitive-motor performance, potentially improving rehabilitation outcomes and quality of life.
How similar studies have performed: Previous studies have shown immediate and lasting benefits from tDCS or tSCS when combined with training, and early reports suggest potential synergy from combining them, but the combined approach is still relatively novel and being characterized.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: CONTROL GROUP: * Over 18 years of age * Participant who has signed an informed consent form * Participant who is affiliated with and covered by the social security system POST-STROKE GROUP: * Over 18 years of age * Who sustained a stroke more than 3 weeks ago * Considered medically stable by the medical investigator * Who has signed an informed consent form * Affiliated with and covered by the social security system SCI GROUP: * Over 18 years of age * Considered to have a complete or incomplete spinal cord injury (i.e., with a score on the Spinal Injury Association (ASIA) Impairment Scale (AIS) score from A to D) * Considered medically stable by the investigating physician * Presenting with quadriplegia due to cervical injury * Who has signed an informed consent form * Affiliated with and covered by the social security system. Exclusion Criteria: * Suffering from a chronic condition * Skin problems or open wounds * History of epilepsy or seizures * Presence of a contraindication to the use of magnetic/electrical stimulation or MRI, including: cardiac pacemaker; implanted hearing aid; intraocular foreign body, shrapnel, or bullets; metal worker; pacemaker or neurostimulator; claustrophobia * Presence of implanted medical devices (cardiac valve, endovascular devices, ventricular shunt valve, surgical clips, metallic sutures, staples, stent, osteosynthesis or arthrodesis hardware) not classified as "MR Conditional" according to ASTM F2503. * Individuals who are legally incompetent, under judicial protection, guardianship, or trusteeship * Pregnant and/or breastfeeding women * Individuals who refuse to be informed of any abnormalities that may be detected by MRI.
Where this trial is running
Bordeaux and 1 other locations
- Service de Médecine Physique & Réadaptation - CHU Bordeaux — Bordeaux, France (Recruiting)
- Centre de la Tour de Gassies — Bruges, France (Recruiting)
Study contacts
- Principal investigator: Fabien Wagner, PhD — Institute of Neurodegenerative Diseases, CNRS UMR 5293
- Study coordinator: Nabila Brihmat, PhD
- Email: nabila.brihmat@u-bordeaux.fr
- Phone: +33 5 33 51 48 46
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.