Assessing Non-invasive Spinal Stimulation to Evaluate its Safety and Effectiveness in Individuals with Spinal Cord Injury
Official Title
ExaStim Upper Limb Pivotal Clinical Validation StudyPurpose
The purpose of this study is to evaluate the safety and effectiveness of ExaStim® transcutaneous spinal stimulation on upper extremity function when applied in combination with physical therapy (PT) and/or occupational therapy (OT).
Participants will be randomized to the stimulation group or a control group. Outcomes will include sensory, motor, and functional tests, as well as questionnaires.
Could this study be right for you?
- Aged 22 years or older
- Traumatic chronic spinal cord injury
- Level of injury between C2-T2
- No active implanted medical device for electrical stimulation
- No Botox for 3 months
- Have a chronic, traumatic SCI (chronic is >12 months since injury, or 6 months if unchanged symptoms)
- Has some, but limited upper extremity function
- BMI <40
- Cannot be pregnant