Ischemic Stroke, AcuteNCT05961293
NeuroGlove fMRI Study
A study testing NeuroGlove in people with Ischemic Stroke, Acute and Stroke, run by NeuroGlove LLC.
Trial summary
This is a prospective, single center, interventional clinical study containing two cohorts the treatment cohort and control cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the control cohort and undergo imaging only. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Acute, Stroke
- What is being tested?
- NeuroGlove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 15 Dec 2024
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able and willing to provide informed consent.
- Men and women ≥18 and <85 years of age.
- Subject must be right hand dominant.
- Subject should not have any physical limitations of either upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
- Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject.
- Men and women ≥18 and <85 years of age.
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- First single acute ischemic stroke with an onset date within 14 days (± 7 days from onset) of enrollment (time of informed consent) into the study.
- Mild to moderate acute ischemic stroke defined as NIHSS score of 3 to 15.
- Measurable weakness of one upper extremity without complete paralysis (detectable movement in at least 3 fingers).
- Subject must be right hand dominant.
Who cannot join
- Coma, inability to cooperate with the study based on impaired level of consciousness or confusion.
- Known neurological deficit prior to stroke (including but not limited to previous stroke, MS, Parkinson's disease).
- Physical limitations of the weak upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
- Any contraindication to the imaging required per the protocol.
- Complete middle cerebral artery infarction based on imaging.
- Carotid artery stenosis >50% of the normal diameter segment (diameter stenosis, compared to the angiographically normal proximal or distal segment).
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- Subjects has a known history of substance abuse (drug) or alcohol dependence, or lacks the ability to comprehend or following instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements.
- If female, subject is pregnant at the time of enrollment or planning to become pregnant during the trial period.
- Subject has any other acute or chronic condition that the investigator believes will adversely affect the ability to interpret the data or will prevent the subject from completing the trial procedures.
- Currently participating in another interventional clinical trial. (Observational clinical trial participation is allowed for study enrollment.)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Peripheral Sensory Stimulation of the Hand in the Treatment of Stroke: A Preliminary Functional MRI Study
This is a prospective, single center, interventional clinical study containing two cohorts the treatment cohort and control cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the control cohort and undergo imaging only. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will receive treatment using the NeuroGlove.
Read the detailed description
This is a prospective, single center, interventional clinical study containing two cohorts the treatment cohort and control cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the control cohort and undergo imaging only. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will receive treatment using the NeuroGlove.
Up to 13 subjects enrolled and complete study procedures. There will be 2 cohorts enrolled in the study:
- Control Cohort: 3 healthy volunteers
- Treatment Cohort: 10 subjects who have experienced mild to moderate stroke symptoms* that did not completely resolve after acute interventions.
- Mild to moderate stroke symptoms is defined as a NIHSSS score of 3 to 15.
- Conditions
- Ischemic Stroke, Acute, Stroke
- Being tested
- NeuroGlove
- Keywords
- Stroke, Ischemic Stroke, Acute Ischemic Stroke
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroGloveDevice
NeuroGlove is a non-invasive device that provides peripheral somatosensory stimulation to the hand of a stroke victim during acute, subacute, or chronic phases of a stroke. NeuroGlove provides sensory stimulation in the forms of pneumatic puffs of air. There is some early evidence that early peripheral sensory stimulation may improve neurological outcomes following an ischemic stroke.
| Study group | Role | What they receive |
|---|---|---|
| Control Cohort (Healthy Cohort) | Other | Healthy participants who participate in 1 study visit. The healthy participant will undergo one functional MRI which using the NeuroGlove. Receives: Device: NeuroGlove |
| Treatment Arm | Experimental | The treatment cohort will undergo two functional MRIs once at baseline and the final fMRI will occur six weeks after initial study visit after daily use of the NeuroGlove. Receives: Device: NeuroGlove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brian Function
Evaluate brain function through a fMRI assessing post-stroke changes in brain activation including functional recruitment of new brain territories in subjects undergoing rehabilitation with the NeuroGlove.
Measured: 6 weeks
Rate of Adverse Events
Rate and severity of adverse events related to the use of the NeuroGlove.
Measured: 6 weeks
Secondary outcomes (4)
Motor Recovery
Evaluate the motor recovery of the affected upper extremity based on the change in hand grip strength from baseline using hand dynamometer
Measured: 6 weeks
NIHSS score
Evaluate neurological recovery as measure by the change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline. The lower the score less severe the stroke symptoms.
Measured: 6 weeks
Rankin Score
Evaluate functional recovery as measured by the modified Rankin Scale (mRS) score. A 0-6 scale is used to measure degree of ability 0 is no disability and 6 is death.
Measured: 6 weeks
Change in QOL
Change in stroke-specific quality of life (SS-QOL) scores from baseline. Scale is 49-245 with higher scores indicating better function.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroGlove LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leslie Nussbaum, Principal investigator, NeuroGlove LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961293
- Sponsor's protocol ID
- REG-1001
- Status last verified
- Nov 2023
- First submitted
- 18 Jul 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan for sharing individual participants data to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Peripheral Sensory Stimulation of the Hand in the Treatment of Stroke: A Preliminary Functional MRI Study
- ClinicalTrials.gov ID
- NCT05961293
- Acronym / sponsor ID
- REG-1001
- Conditions
- Ischemic Stroke, Acute, Stroke
- Keywords
- Stroke, Ischemic Stroke, Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- NeuroGlove LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 27 Jul 2023 (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 prospective, single center, interventional clinical study containing two cohorts the treatment cohort and control cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the control cohort and undergo imaging only. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will receive treatment using the NeuroGlove.
Detailed description
This is a prospective, single center, interventional clinical study containing two cohorts the treatment cohort and control cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the control cohort and undergo imaging only. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will receive treatment using the NeuroGlove.
Up to 13 subjects enrolled and complete study procedures. There will be 2 cohorts enrolled in the study:
- Control Cohort: 3 healthy volunteers
- Treatment Cohort: 10 subjects who have experienced mild to moderate stroke symptoms* that did not completely resolve after acute interventions.
- Mild to moderate stroke symptoms is defined as a NIHSSS score of 3 to 15.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Cohort (Healthy Cohort) | Other | Device: NeuroGloveHealthy participants who participate in 1 study visit. The healthy participant will undergo one functional MRI which using the NeuroGlove. |
| Treatment Arm | Experimental | Device: NeuroGloveThe treatment cohort will undergo two functional MRIs once at baseline and the final fMRI will occur six weeks after initial study visit after daily use of the NeuroGlove. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able and willing to provide informed consent.
- Men and women ≥18 and <85 years of age.
- Subject must be right hand dominant.
- Subject should not have any physical limitations of either upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
- Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject.
Key exclusion criteria (10 listed)
- Coma, inability to cooperate with the study based on impaired level of consciousness or confusion.
- Known neurological deficit prior to stroke (including but not limited to previous stroke, MS, Parkinson's disease).
- Physical limitations of the weak upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
- Any contraindication to the imaging required per the protocol.
- Complete middle cerebral artery infarction based on imaging.
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 |
|---|---|---|
| NeuroGloveNeuroGlove is a non-invasive device that provides peripheral somatosensory stimulation to the hand of a stroke victim during acute, subacute, or chronic phases of a stroke. NeuroGlove provides sensory stimulation in the forms of pneumatic puffs of air. There is some early evidence that early peripheral sensory stimulation may improve neurological outcomes following an ischemic stroke. | Device | Control Cohort (Healthy Cohort), Treatment Arm |
Primary outcome
Brian Function
Time frame: 6 weeks
Evaluate brain function through a fMRI assessing post-stroke changes in brain activation including functional recruitment of new brain territories in subjects undergoing rehabilitation with the NeuroGlove.
Rate of Adverse Events
Time frame: 6 weeks
Rate and severity of adverse events related to the use of the NeuroGlove.
4 secondary outcomes
Motor Recovery
Time frame: 6 weeks
NIHSS score
Time frame: 6 weeks
Rankin Score
Time frame: 6 weeks
Change in QOL
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No. There is no plan for sharing individual participants data to other researchers.
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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.
Leslie Nussbaum principal investigator
NeuroGlove LLC
Questions about this trial
What is this clinical trial studying?
A study testing NeuroGlove in people with Ischemic Stroke, Acute and Stroke, run by NeuroGlove LLC.
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 10 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Harold (612.255.0405, tharold@neuroglove.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brian Function (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 27 Aug 2024.