ExaStim Upper Limb Home Use Clinical Validation Study

Inclusion 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