Spinal Cord DiseasesNCT04683471
Pilot Trial of a System for Motor Function Recovery
A study testing Stimulator in people with Spinal Cord Diseases, run by Niche Biomedical, Inc. dba ANEUVO at 3 sites in United States.
Trial summary
This is a multi-center, prospective, blinded, pilot feasibility study to evaluate improvement in sensory and motor function with sham. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Spinal Cord Diseases
- What is being tested?
- Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Nov 2020to 22 Mar 2022
- 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
- Traumatic chronic spinal cord injury
Who cannot join
- Active implanted medical device
- Internal metallic objects of unknown or foreign origin
- Implanted anti-spasticity pumps, Botox injections in prior 3 months or other current anti-spasticity regimen
- BMI > 40.0
- Acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds
- Pregnancy or planned pregnancy
Show all 10Show fewer
- Unhealed bone fractures, peripheral neuropathies or painful musculoskeletal dysfunction
- Cardiopulmonary disease or ventilator dependency
- Uncontrolled epilepsy or seizures
- Clinically significant depression, psychiatric disorders or ongoing substance abuse
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Houston Methodist Research Institute
Houston, Texas, 77030
About this study
Official title: Pilot Feasibility Clinical Validation Study
This is a multi-center, prospective, blinded, pilot feasibility study to evaluate improvement in sensory and motor function with sham.
- Conditions
- Spinal Cord Diseases
- Being tested
- Stimulator, Sham
- Medical subject headings
- Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimulatorDevice
Neuromodulation
ShamDevice
Sham
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation | Experimental | Neuromodulation Receives: Device: Stimulator |
| Sham | Sham comparator | Sham Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) for the upper limbs
Scoring:
- Strength scored 0 - 50 for each arm
- Sensibility scored 0 - 24 for each arm
- Prehension scored 0 - 42 for each arm
- Higher scores are a better outcome
Measured: Biweekly through study completion up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start30 Nov 2020
- Primary completion22 Dec 2021
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord DiseasesStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 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
- NCT04683471
- Sponsor's protocol ID
- EXA-2001
- Status last verified
- Apr 2022
- First submitted
- 15 Dec 2020
- Last updated
- 13 Apr 2022
- Results posted
- 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 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Clinical Validation Study
- ClinicalTrials.gov ID
- NCT04683471
- Acronym / sponsor ID
- EXA-2001
- Conditions
- Spinal Cord Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Niche Biomedical, Inc. dba ANEUVOIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 24 Dec 2020 (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, prospective, blinded, pilot feasibility study to evaluate improvement in sensory and motor function with sham.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromodulation | Experimental | Device: StimulatorNeuromodulation |
| Sham | Sham comparator | Device: ShamSham |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Traumatic chronic spinal cord injury
Key exclusion criteria (10 listed)
- Active implanted medical device
- Internal metallic objects of unknown or foreign origin
- Implanted anti-spasticity pumps, Botox injections in prior 3 months or other current anti-spasticity regimen
- BMI > 40.0
- Acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds
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 |
|---|---|---|
| StimulatorNeuromodulation | Device | Neuromodulation |
| ShamSham | Device | Sham |
Primary outcome
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Time frame: Biweekly through study completion up to 18 weeks
Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) for the upper limbs Scoring: * Strength scored 0 - 50 for each arm * Sensibility scored 0 - 24 for each arm * Prehension scored 0 - 42 for each arm * Higher scores are a better outcome
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 2022.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulator in people with Spinal Cord Diseases, run by Niche Biomedical, Inc. dba ANEUVO at 3 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 1 inclusion and 10 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 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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?
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) (time frame: Biweekly through study completion up to 18 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 2022.