ExaStim Upper Limb Home Use Clinical Validation Study

Launched by NICHE BIOMEDICAL, INC. DBA ANEUVO · Feb 21, 2025

Keywords

ClinConnect Summary

The ExaStim Upper Limb Home Use Clinical Validation Study is looking to evaluate a new device called the ExaStim system, which uses a method called transcutaneous spinal cord stimulation to help individuals with spinal cord injuries. This study will last for six weeks and will involve participants using the device at home for four weeks. The goal is to see how safe and effective this method is in improving upper limb function for people who have suffered a traumatic spinal cord injury.

To be eligible for this study, participants need to be at least 22 years old and have already completed another clinical trial called ASPIRE. They should have a spinal cord injury between the C2 and T2 vertebrae and limited function in their arms. Participants will need the help of a caregiver or family member to assist with using the device and completing study-related forms. Throughout the six weeks, participants will go through training, use the device, and attend follow-up visits to track their progress. This study is not yet recruiting participants, but it aims to gather important information that could help improve treatment for those with spinal cord injuries.

Gender

ALL

Eligibility 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