ExaStim Upper Limb Home Use Clinical Validation Study (NCT06850363) | Clinical Trial Compass
CompletedNot Applicable
ExaStim Upper Limb Home Use Clinical Validation Study
United States33 participantsStarted 2025-03-17
Plain-language summary
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.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕
What they're measuring
1
Safety: Incidence of device related adverse events
. 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