ExaStim Upper Limb Home Use Clinical Validation Study

NCT06850363 | Completed FDA Device

• 1 other identifier: EXA2504
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 5

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.

Conditions

Cervical Spinal Cord Injury

Keywords

Neuromodulation; Spinal Cord Therapy; Rehabilitation; Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Canadian Occupational Performance Measure

  change from baseline to week-5

• Patient Global Impression of Change (PGIC)

  score at week 5

• Psychosocial Impact of Assistive Devices Scale

  score at week 5

• Capabilities of Upper Extremity Test

  maintenance or change from baseline to week 5

• Upper Extremity Motor Score

  maintenance or change from baseline to week 5

Study Arms (1)

Transcutaneous Spinal Stimulation in the home setting

EXPERIMENTAL

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

Interventions

ExaStim Stimulation System DEVICE

Transcutaneous Spinal Cord Stimulation

Also known as: ExaStim

Transcutaneous Spinal Stimulation in the home setting

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Niche Biomedical, Inc. dba ANEUVO: lead

Study Sites (5)

Craig Rehabilitation Hospital

Denver, Colorado, 80113, United States

Location

TryAbility Neurorecovery Center

Downer Grove, Illinois, 60515, United States

Location

Internation Center for Spinal Cord Injury at the Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02138, United States

Location

Marquette University Neuro Recovery Clinic

Milwaukee, Wisconsin, 53233, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 27, 2025
• Study Start: March 17, 2025
• Primary Completion: March 11, 2026
• Study Completion: March 11, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (5)