ExaStim Upper Limb Home Use Clinical Validation Study

Eligibility Criteria

• 1. Subject must have completed the ASPIRE clinical trial.
• 2. Subject must be ≥ 22 years of age at the time of the screening examination
• 3. Subject must have a traumatic, chronic\* spinal cord injury between C2 and T2 inclusive
• 4. Subject must have American Spinal Injury Association (ASIA) Impairment Scale A, B, C, or D via the ISNCSCI exam
• 5. Subject must have limited function of upper extremities with ISNCSCI Upper Extremity Motor Score for each arm from 5 to 20 inclusive
• 6. Subject must have a non-zero score in least one of the UEMS C7, C8 and T1 muscles on either side
• 7. Subject must have regular availability of a caregiver and/or family member to assist with donning and doffing the device and to assist with completion of session-related report forms
• 8. Subject, caregiver, and/or family member must be available for all in-clinic study visits and adhere to the study protocol
• 9. Subject, caregiver and/or family member must be able to use a digital mobile device, have reliable access to internet, and be able to complete all study related forms and questionnaires
• 10. Subject and caregiver must be able to commit to participating in a six-week study, be willing to comply with study instructions, agree to make all office and telehealth appointments, engage in a minimum of 12-minutes of home activities with stimulation per week, and complete the entire course of the study
• 11. Subject must be a primary/fluent English speaker
• 12. Subject must be able and willing to read, comprehend and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent
• 1. Active implanted medical device for electrical stimulation
• 2. Other internal metallic objects of unknown or foreign origin (unidentifiable surgical implants, shrapnel, bullet fragments, etc.)
• 3. Botox injections to the upper limb in prior 6 months
• 4. Uncontrolled autonomic dysreflexia or orthostatic hypotension
• 5. BMI \> 40.0 (morbid obesity)
• 6. Acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds, unhealed bone fractures, peripheral neuropathies or painful musculoskeletal dysfunction
• 7. Subjects who are pregnant or planned pregnancy during the study. Note: Subjects of childbearing potential must agree to the use an effective contraceptive for the duration of the study.
• 8. Allergy to hydrogel, silicone, latex or other product materials
• 9. Compromised skin in the area for electrode contact (back of neck and/or hip area)
• 10. Uncontrolled cardiopulmonary disease
• 11. Ventilator dependency
• 12. Uncontrolled epilepsy or seizures
• 13. Unmanaged depression, psychiatric disorders or ongoing substance abuse
• 14. Participation in another clinical trial that may interfere with this study