NCT07334977 Synergistic Effect of Non-invasive Brain and Spinal Cord Stimulation
| NCT ID | NCT07334977 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre National de la Recherche Scientifique, France |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-12-11 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2024-12-11 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical study is to investigate the potential synergy between non-invasive brain and spinal cord stimulation administered during a cognitive-motor task, in terms of their immediate effects on sensorimotor and cognitive functions after neurological injuries affecting the upper limb (cervical spinal cord injury and stroke). Secondary objectives are to evaluate the relevance of anatomical MRI, functional MRI, and neurophysiological measurements for optimizing and predicting the effects of these different interventions.
Eligibility 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.
Contact & Investigator
Fabien Wagner, PhD
PRINCIPAL INVESTIGATOR
Institute of Neurodegenerative Diseases, CNRS UMR 5293
Frequently Asked Questions
Who can join the NCT07334977 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07334977 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07334977 currently recruiting?
Yes, NCT07334977 is actively recruiting participants. Contact the research team at nabila.brihmat@u-bordeaux.fr for enrollment information.
Where is the NCT07334977 trial being conducted?
This trial is being conducted at Bordeaux, France, Bruges, France.
Who is sponsoring the NCT07334977 clinical trial?
NCT07334977 is sponsored by Centre National de la Recherche Scientifique, France. The principal investigator is Fabien Wagner, PhD at Institute of Neurodegenerative Diseases, CNRS UMR 5293. The trial plans to enroll 45 participants.
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