ExaStim Upper Limb Home Use Clinical Validation Study

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.

Study Overview

• Status: Completed
• Conditions: Cervical Spinal Cord Injury
• Intervention / Treatment: Device: ExaStim Stimulation System

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80113
      • Craig Rehabilitation Hospital
  • Illinois
    • Downer Grove, Illinois, United States, 60515
      • TryAbility Neurorecovery Center
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Internation Center for Spinal Cord Injury at the Kennedy Krieger Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02138
      • Spaulding Rehabilitation Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • Marquette University Neuro Recovery Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Transcutaneous Spinal Stimulation in the home setting; Subjects will perform activities of daily living 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 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.

Device: ExaStim Stimulation System; Transcutaneous Spinal Cord Stimulation; Other Names: ExaStim

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Incidence of device related adverse events	Incidence of device related adverse events over the course of the trial. no scoring requirement	Occurrence over 6-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Canadian Occupational Performance Measure	is an individualized, client-centered instrument designed to measure an individual's self-perception of physical functioning and satisfaction in the activities identified as important by the client. COPM score ranges from 0-50, higher scores mean a better outcome.	change from baseline to week-5
Patient Global Impression of Change (PGIC)	The Patient Global Impression of Change Questionnaire is rated on a 10-point scale depicting a patient's rating of overall improvement. This self-reported scale reflects a patient's belief about the efficacy of treatment. score range from 0-10 with lower scores showing considerable imrpovement.	score at week 5
Psychosocial Impact of Assistive Devices Scale	The PIADS Questionnaire is a 26-item self-reported questionnaire designed to assess the effects of an assistive device on functional independence, well-being and quality of life. Score range of 0-182 points with higher scores reflecting positive impact.	score at week 5
Capabilities of Upper Extremity Test	The CUE-T is an objective performance measure to assess upper extremity functional limitations in spinal cord injury individuals. CUE-T score ranges from 0 to 140, higher scores mean a better outcome.	maintenance or change from baseline to week 5
Upper Extremity Motor Score	UEMS is a sub score of the ISNSCSCI. The ISNCSCI exam is a standardized tool traditionally used in clinical trials to broadly assess motor and sensory changes in individuals after spinal cord injury. The UEMS, a sub score of the ISNCSCI exam, better reflects meaningful recovery in the arms and hands, an area of utmost importance to individuals living with tetraplegia. The UEMS grades on a scale of 0-50, higher scores mean a better outcome.	maintenance or change from baseline to week 5

Collaborators and Investigators

• Sponsor: Niche Biomedical, Inc. dba ANEUVO

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Actual): March 11, 2026
• Study Completion (Actual): March 11, 2026

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Neuromodulation; Electrical Stimulation; Spinal Cord Therapy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: EXA2504

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No