Combining non-invasive brain and spinal cord stimulation to improve arm and hand function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.