Testing Safety and Effectiveness of Spinal Cord Stimulation with Activity Training to Improve Arm and Hand Function in People with Recent Cervical Spinal Cord Injury

What this Trial Is About

Researchers are studying the safety and practicality of spinal cord transcutaneous stimulation scTS combined with activity-based training ABT for people with acute to subacute cervical spinal cord injury SCI during inpatient rehabilitation. The trial aims to see if this combined approach is safe, feasible, and whether it improves hand, arm, and trunk function better than ABT alone or a sham stimulation control. The study also explores changes in brain and spinal cord activity to understand how these treatments may work. Participants are randomly assigned to one of three groups scTS with ABT, sham scTS with ABT, or ABT only. Treatments are given over 10 sessions across 2 weeks, each lasting 30 minutes as part of daily therapy. The active scTS involves skin electrodes delivering mild stimulation to the cervical and thoracic spine, adjusted for comfort without visible muscle contractions. The sham group receives a brief, low-level stimulation to mimic sensations without therapeutic effects, while the ABT group focuses on upper limb motor tasks like grasping and pinching. Participants undergo assessments before, during, and after the intervention, plus follow-ups at 1, 2, and 3 months. Safety is monitored by tracking pain, skin condition, adverse events, and vital signs. Functional outcomes include hand strength and upper limb motor skills measured by specific tests. Researchers also evaluate study completion rates and will compare changes in cortical and spinal excitability to assess the interventions impact. The total study duration for each participant is about 3 months from start to final follow-up.

Combining Spinal Cord Transcutaneous Stimulation and Activity-based Training in Inpatient Rehabilitation to Facilitate Upper Limb Function of Individuals with Acute to Subacute Cervical Spinal Cord Injury