ExaStim Upper Limb Home Use Clinical Validation Study

Completed · Not applicable

Conditions studied: Cervical Spinal Cord Injury

In brief

This is a multi-center, observational, single-arm, 6-week home study to evaluate the safety and efficacy of transcutaneous spinal cord stimulation via the ExaStim system for 4 consecutive weeks used in the home setting for individuals with traumatic spinal cord injury. The study consists of a baseline evaluation and 1-week training period (Week 0), a 4-week stimulation period (Weeks 1-4), and a follow-up visit (Week 5), for a total expected duration of participation for each subject of six weeks.

Key facts

Study ID

NCT06850363

Run by

Niche Biomedical, Inc. dba ANEUVO

People needed

33

Starts

2025-03-17

Expected to finish

2026-03-11

Last updated by the study team

2026-04-13

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must have completed the ASPIRE clinical trial.
• Subject must be ≥ 22 years of age at the time of the screening examination
• Subject must have a traumatic, chronic* spinal cord injury between C2 and T2 inclusive
• Subject must have American Spinal Injury Association (ASIA) Impairment Scale A, B, C, or D via the ISNCSCI exam
• Subject must have limited function of upper extremities with ISNCSCI Upper Extremity Motor Score for each arm from 5 to 20 inclusive
• Subject must have a non-zero score in least one of the UEMS C7, C8 and T1 muscles on either side
• 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
• Subject, caregiver, and/or family member must be available for all in-clinic study visits and adhere to the study protocol
• 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
• 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
• Subject must be a primary/fluent English speaker
• Subject must be able and willing to read, comprehend and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent

You may not qualify if…

• Active implanted medical device for electrical stimulation
• Other internal metallic objects of unknown or foreign origin (unidentifiable surgical implants, shrapnel, bullet fragments, etc.)
• Botox injections to the upper limb in prior 6 months
• Uncontrolled autonomic dysreflexia or orthostatic hypotension
• BMI > 40.0 (morbid obesity)
• Acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds, unhealed bone fractures, peripheral neuropathies or painful musculoskeletal dysfunction
• 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.
• Allergy to hydrogel, silicone, latex or other product materials
• Compromised skin in the area for electrode contact (back of neck and/or hip area)
• Uncontrolled cardiopulmonary disease
• Ventilator dependency
• Uncontrolled epilepsy or seizures
• Unmanaged depression, psychiatric disorders or ongoing substance abuse
• Participation in another clinical trial that may interfere with this study

Where it is running

• Craig Rehabilitation Hospital — Denver, Colorado, United States
• TryAbility Neurorecovery Center — Downer Grove, Illinois, United States
• Internation Center for Spinal Cord Injury at the Kennedy Krieger Institute — Baltimore, Maryland, United States
• Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States
• Marquette University Neuro Recovery Clinic — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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