Home use of ExaStim system for spinal cord injury rehabilitation
ExaStim Upper Limb Home Use Clinical Validation Study
This study tests if using the ExaStim system at home can help people with spinal cord injuries improve their arm function while doing exercises.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Niche Biomedical, Inc. dba ANEUVO Industry-sponsored |
| Locations | 5 sites (Denver, Colorado and 4 other locations) |
| Trial ID | NCT06850363 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of the ExaStim system, which provides transcutaneous spinal cord stimulation, for individuals with traumatic spinal cord injuries. Participants will undergo a baseline evaluation followed by a one-week training phase, after which they will use the stimulation system at home while performing prescribed exercises for four weeks. Weekly telehealth check-ins will ensure adherence and monitor progress. The study aims to assess how well this home-based approach can improve upper limb function in patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older with chronic traumatic spinal cord injuries between C2 and T2 and limited upper extremity function.
Not a fit: Patients with non-traumatic spinal cord injuries or those who do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation outcomes and improve daily functioning for patients with spinal cord injuries.
How similar studies have performed: Other studies have shown promise with similar neuromodulation approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Denver, Colorado and 4 other locations
- Craig Rehabilitation Hospital — Denver, Colorado, United States (Recruiting)
- TryAbility Neurorecovery Center — Downer Grove, Illinois, United States (Recruiting)
- Internation Center for Spinal Cord Injury at the Kennedy Krieger Institute — Baltimore, Maryland, United States (Recruiting)
- Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States (Recruiting)
- Marquette University Neuro Recovery Clinic — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Liza McHugh, DPT, PT
- Email: Liza@aneuvo.com
- Phone: 860-575-4972
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.