Study of Combined Non-invasive Brain and Spinal Cord Stimulation During Cognitive-Motor Training to Improve Sensorimotor and Cognitive Functions After Stroke or Spinal Cord Injury

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.

Synergistic Effect of Non-invasive Brain and Spinal Cord Stimulation