Participants should consider the study time commitments and their ability to see the study doctors as required before agreeing to participate. The study visits include:
One week screening/baseline evaluation period. During the first week, screening will be completed, and baseline measurements will be recorded to determine eligibility. This may require more than one office visit.
Active/Sham Therapy Period
Eight-week period. Over the active/sham therapy period, eligible patients will have three weekly rehabilitation therapy sessions (S1, S2, and S3) targeting upper limb function over the course of 8 weeks for a total of 24 sessions. Each therapy session will last up to two hours, with a minimum of 30 minutes and maximum of 60 minutes of standard rehabilitation therapy. Additional time will be required during a fourth weekly session (S4) on weeks four, and eight to complete additional study assessments. These S4 study visits are anticipated to take up to three hours.
Patients will be randomly assigned to the Sham group or Active group. Patients in the Sham group will receive sham stimulation therapy in combination with standard physical/occupational therapy. Patients in the Active group will receive ExaStim® TSS therapy in combination with standard physical/occupational therapy. Both patients and clinical assessors will be blinded (or unaware) of which group a patient has been assigned to.
Therapy programs will be tailored to each patient’s level of SCI, medical history, and personal therapy goals.
Three-week follow-up period. Three weeks after therapy is complete, patients will return for one follow-up visit to complete exit assessments.