Actively Recruiting
Synergistic Potential of Non-invasive Brain and Spinal Cord Stimulation for Improving Sensorimotor and Cognitive Functions After Neurological Injury
Led by Centre National de la Recherche Scientifique, France · Updated on 2026-01-12
45
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
Sponsors
C
Centre National de la Recherche Scientifique, France
Lead Sponsor
U
University Hospital, Bordeaux
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how combining non-invasive brain and spinal cord stimulation during cognitive-motor tasks might improve sensorimotor and cognitive functions after neurological injuries like cervical spinal cord injury and stroke. This study also aims to assess how anatomical MRI, functional MRI, and neurophysiological tests can help optimize and predict the effects of these stimulation techniques. The study is a Phase 2, single-center, randomized, crossover, single-blind clinical trial involving control participants and those with neurological injuries. Participants will receive four different neuromodulation interventions: transcranial direct current stimulation (tDCS), transcutaneous spinal cord stimulation (tSCS), a combination of tDCS and tSCS, and a sham (placebo) stimulation. Each intervention lasts 20 minutes and is administered during a cognitive-motor training task using the Armeo upper limb rehabilitation exoskeleton. Participants with spinal cord injury or stroke will complete nine visits, including inclusion, testing, and intervention visits, while control participants attend only inclusion and testing visits. Throughout the study, participants will undergo neurophysiological tests and clinical performance evaluations immediately after each intervention session. Outcome measures include sensory performance, hand grasping ability, cognitive function, safety, and feasibility of the interventions. Neurophysiological assessments will also be conducted to measure reflex responses. The study lasts several weeks with visits scheduled on specific days to monitor the immediate effects of each intervention.
CONDITIONS
Brief Title
Synergistic Effect of Non-invasive Brain and Spinal Cord Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Control group participants must be over 18 years old
- Must have signed an informed consent form
- Must be affiliated with and covered by social security
- Post-stroke participants must be over 18 years old
- Stroke must have occurred more than 3 weeks ago
- Must be medically stable as determined by the investigator
- Must have signed an informed consent form
- Must be affiliated with and covered by social security
- Spinal cord injury participants must be over 18 years old
- Must have a complete or incomplete cervical spinal cord injury (ASIA Impairment Scale A to D)
- Must be medically stable as determined by the investigator
- Must have quadriplegia due to cervical injury
- Must have signed an informed consent form
- Must be affiliated with and covered by social security
You will not qualify if you...
- Presence of a chronic condition
- Skin problems or open wounds
- History of epilepsy or seizures
- Contraindications to magnetic or electrical stimulation or MRI, including cardiac pacemaker, implanted hearing aid, intraocular foreign body, shrapnel, bullets, metal worker, pacemaker, neurostimulator, or claustrophobia
- Implanted medical devices not classified as "MR Conditional" such as cardiac valves, endovascular devices, shunt valves, surgical clips, metal sutures, staples, stents, osteosynthesis or arthrodesis hardware
- Individuals who are legally incompetent or under guardianship or trusteeship
- Pregnant or breastfeeding women
- Individuals refusing to be informed of MRI abnormalities
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants undergo testing visits to determine optimal stimulation sites and intensities, as well as neurophysiological assessments.
5 visits (in-person)
Duration - 4 intervention visits over approximately 2 weeks
Participants receive one of four neuromodulation interventions combined with a cognitive-motor training task during each intervention visit.
4 visits (in-person)
Duration - Concurrent with intervention visits
Participants perform outcome assessments immediately after interventions to evaluate sensory, motor, and cognitive performance.
4 visits (immediate post-intervention assessments)
Trial Site Locations
Total: 2 locations
1
Service de Médecine Physique & Réadaptation - CHU Bordeaux
Bordeaux, France, 33000
Actively Recruiting
2
Centre de la Tour de Gassies
Bruges, France, 33520
Actively Recruiting
Research Team
N
Nabila Brihmat, PhD
F
Fabien Wagner, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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