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.
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
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.
- Conditions
- Cervical Spinal Cord Injury
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ExaStim Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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.
- First posted27 Feb 2025
- Study start17 Mar 2025
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Niche Biomedical, Inc. dba ANEUVO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExaStim Upper Limb Home Use Clinical Validation Study
- ClinicalTrials.gov ID
- NCT06850363
- Acronym / sponsor ID
- EXA2504
- Conditions
- Cervical Spinal Cord Injury
- Keywords
- Neuromodulation, Spinal Cord Therapy, Rehabilitation, Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Niche Biomedical, Inc. dba ANEUVOIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Spinal Stimulation in the home setting | Experimental | Device: ExaStim Stimulation SystemSubjects 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExaStim Stimulation SystemAlso: ExaStimTranscutaneous Spinal Cord Stimulation | Device | Transcutaneous Spinal Stimulation in the home setting |
Primary outcome
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
5 secondary outcomes
Canadian Occupational Performance Measure
Time frame: change from baseline to week-5
Patient Global Impression of Change (PGIC)
Time frame: score at week 5
Psychosocial Impact of Assistive Devices Scale
Time frame: score at week 5
Capabilities of Upper Extremity Test
Time frame: maintenance or change from baseline to week 5
Upper Extremity Motor Score
Time frame: maintenance or change from baseline to week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 27 Oct 2026.