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Cervical Spinal Cord InjuryNCT06850363

ExaStim Upper Limb Home Use Clinical Validation Study

A study testing ExaStim Stimulation System in people with Cervical Spinal Cord Injury, run by Niche Biomedical, Inc. dba ANEUVO at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Cervical Spinal Cord Injury
What is being tested?
ExaStim Stimulation System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
5 sitesUnited States
Study dates
17 Mar 2025to 11 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Internation Center for Spinal Cord Injury at the Kennedy Krieger Institute

    Baltimore, Maryland, 21205

  • Spaulding Rehabilitation Hospital

    Boston, Massachusetts, 02138

  • Craig Rehabilitation Hospital

    Denver, Colorado, 80113

  • TryAbility Neurorecovery Center

    Downer Grove, Illinois, 60515

  • Marquette University Neuro Recovery Clinic

    Milwaukee, Wisconsin, 53233

Other trials in United States

About this 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.

Read the 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.

Being tested
ExaStim Stimulation System
Keywords
Neuromodulation, Spinal Cord Therapy, Rehabilitation, Electrical Stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExaStim Stimulation SystemDevice

    Also called ExaStim

    Transcutaneous Spinal Cord Stimulation

Study groups in NCT06850363
Study groupRoleWhat they receive
Transcutaneous Spinal Stimulation in the home settingExperimentalSubjects 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.
Receives: Device: ExaStim Stimulation System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Incidence of device related adverse events

    Incidence of device related adverse events over the course of the trial. no scoring requirement

    Measured: Occurrence over 6-weeks

Secondary outcomes (5)

  1. 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.

    Measured: change from baseline to week-5

  2. 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.

    Measured: score at week 5

  3. 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.

    Measured: score at week 5

  4. 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.

    Measured: maintenance or change from baseline to week 5

  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.

    Measured: maintenance or change from baseline to week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2025
  2. Study start17 Mar 2025
  3. Primary completion11 Mar 2026
  4. Study completion11 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06850363
Sponsor's protocol ID
EXA2504
Status last verified
Apr 2026
First submitted
4 Feb 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing ExaStim Stimulation System in people with Cervical Spinal Cord Injury, run by Niche Biomedical, Inc. dba ANEUVO at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Incidence of device related adverse events (time frame: Occurrence over 6-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06850363.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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