ExaStim Upper Limb Home Use Clinical Validation Study

April 9, 2026 updated by: Niche Biomedical, Inc. dba ANEUVO
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Liza McHugh, DPT, PT
  • Phone Number: 860-575-4972
  • Email: Liza@aneuvo.com

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety: Incidence of device related adverse events
Time Frame: Occurrence over 6-weeks
Incidence of device related adverse events over the course of the trial. no scoring requirement
Occurrence over 6-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure
Time Frame: change from baseline to week-5
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)
Time Frame: score at week 5
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
Time Frame: score at week 5
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
Time Frame: maintenance or change from baseline to week 5
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
Time Frame: maintenance or change from baseline to week 5
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Niche Biomedical, Inc. dba ANEUVO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings