Clinical trial NCT06850363: ExaStim Upper Limb Home Use Clinical Validation Study
Official title: ExaStim Upper Limb Home Use Clinical Validation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Spinal Cord Injury
Keywords: Neuromodulation
Spinal Cord Therapy
Rehabilitation
Electrical Stimulation
Lead sponsor: Niche Biomedical, Inc. dba ANEUVO
Sponsor class: INDUSTRY
First posted: 2025-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: During the first week of the study, baseline measurements will be recorded for each subject and all eligible subjects and their caregivers will participate in a 1-week "Training Phase." Subsequently, subjects will perform activities of daily living and/or home exercises in conjunction with the ExaStim over a 4-week period in the home setting. In each session, subjects will receive stimulation while performing therapist-prescribed home exercises or activities of daily living. Stimulation must be utilized for a maximum of 300 -minutes per week and a minimum of 125-minutes per week. The time spent using stimulation during home sessions, and the number of sessions that patients perform each week, is flexible and is intended to facilitate the use of ExaStim within each participant's daily routine. Subjects and Clinicians will participate in weekly telehealth check-ins throughout the 4-week period in the home setting and will return to the clinic within one week of the final treatment to complete the final assessments in the study.

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

Primary outcomes:
measure: Safety: Incidence of device related adverse events
timeFrame: Occurrence over 6-weeks
Secondary outcomes:
measure: Canadian Occupational Performance Measure
timeFrame: change from baseline to week-5
measure: Patient Global Impression of Change (PGIC)
timeFrame: score at week 5
measure: Psychosocial Impact of Assistive Devices Scale
timeFrame: score at week 5
measure: Capabilities of Upper Extremity Test
timeFrame: maintenance or change from baseline to week 5
measure: Upper Extremity Motor Score
timeFrame: maintenance or change from baseline to week 5
Other outcomes:
Locations:
city: Denver
country: United States
facility: Craig Rehabilitation Hospital
state: Colorado
city: Downer Grove
country: United States
facility: TryAbility Neurorecovery Center
state: Illinois
city: Baltimore
country: United States
facility: Internation Center for Spinal Cord Injury at the Kennedy Krieger Institute
state: Maryland
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
city: Milwaukee
country: United States
facility: Marquette University Neuro Recovery Clinic
state: Wisconsin
Study officials:
References: