New device lets spinal injury patients stimulate nerves at home to improve hand use

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 Exclusion Criteria: 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