Ischemic StrokeNCT06573840
A Functional MRI Study: Assessing Brain Function in Post Stoke Patients
A study testing NeuroGlove in people with Ischemic Stroke and Stroke, run by NeuroGlove LLC.
Trial summary
This is a prospective, single center, observational clinical study containing two cohorts the healthy cohort and post stroke cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the healthy cohort. 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, Stroke, Acute Ischemic 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2024to 15 Nov 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. 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. Subject should not have any physical limitations of either upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
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).
- 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.)
About this study
This is a prospective, single center, observational clinical study containing two cohorts the healthy cohort and post stroke cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the healthy cohort. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will be enrolled in the post stroke cohort.
Read the detailed description
This is a prospective, single center, observational clinical study containing two cohorts the healthy cohort and post stroke cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the healthy cohort. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will be enrolled in the post stroke cohort.
Up to13 subjects will be enrolled and complete study procedures. There will be 2 study cohorts enrolled in the study:
- Healthy Cohort: 3 healthy volunteers (enrolled from the general population)
- Post Stroke 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 NIHSS score of 5 to 15.)
- Conditions
- Ischemic Stroke, Stroke, Acute Ischemic 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. NeuroGlove provides sensory stimulation in the form of pneumatic puffs of air.
| Study group | Role | What they receive |
|---|---|---|
| Control Cohort (Healthy Cohort) | Active comparator | Healthy participants who participate in 1 study visit. The unhealthy participant will undergo one functional MRI before, during and after a NeuroGlove session. Receives: Device: NeuroGlove |
| Treatment Arm | Active comparator | The treatment cohort which consists of patients who have experienced an acute ischemic stroke will participate in 1 study visit. They will undergo 1 function MRI before, during and after a NeuroGlove session. Receives: Device: NeuroGlove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Function
Evaluate brain function through a functional MRI (fMRI) in both healthy subjects (without history of stroke) and post stroke patients.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start10 Nov 2024 (estimated)
- Primary completion14 Nov 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Why it stopped: business re-focus
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 healthy volunteers and 10 post stroke patients will be enrolled in the study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroGlove LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Nussbaum, MD, Study director, NeuroGlove LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573840
- Sponsor's protocol ID
- REG-1005
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 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
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
- A Functional MRI Study: Assessing Brain Function in Post Stoke Patients
- ClinicalTrials.gov ID
- NCT06573840
- Acronym / sponsor ID
- REG-1005
- Conditions
- Ischemic Stroke, Stroke, Acute Ischemic Stroke
- Keywords
- Stroke, Ischemic Stroke, Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: business re-focus
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NeuroGlove LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 14 Nov 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 27 Aug 2024 (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, observational clinical study containing two cohorts the healthy cohort and post stroke cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the healthy cohort. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will be enrolled in the post stroke cohort.
Detailed description
This is a prospective, single center, observational clinical study containing two cohorts the healthy cohort and post stroke cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the healthy cohort. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will be enrolled in the post stroke cohort.
Up to13 subjects will be enrolled and complete study procedures. There will be 2 study cohorts enrolled in the study:
- Healthy Cohort: 3 healthy volunteers (enrolled from the general population)
- Post Stroke 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 NIHSS score of 5 to 15.)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3 healthy volunteers and 10 post stroke patients will be enrolled in the study.
| Arm | Type | Receives |
|---|---|---|
| Control Cohort (Healthy Cohort) | Active comparator | Device: NeuroGloveHealthy participants who participate in 1 study visit. The unhealthy participant will undergo one functional MRI before, during and after a NeuroGlove session. |
| Treatment Arm | Active comparator | Device: NeuroGloveThe treatment cohort which consists of patients who have experienced an acute ischemic stroke will participate in 1 study visit. They will undergo 1 function MRI before, during and after a NeuroGlove session. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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.
- Men and women ≥18 and <85 years of age. 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. Subject should not have any physical limitations of either upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
Key exclusion criteria (7 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. Carotid artery stenosis >50% of the normal diameter segment (diameter stenosis, compared to the angiographically normal proximal or distal segment).
- 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.
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. NeuroGlove provides sensory stimulation in the form of pneumatic puffs of air. | Device | Control Cohort (Healthy Cohort), Treatment Arm |
Primary outcome
Brain Function
Time frame: 2 hours
Evaluate brain function through a functional MRI (fMRI) in both healthy subjects (without history of stroke) and post stroke patients.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Eric Nussbaum, MD study director
NeuroGlove LLC
Questions about this trial
What is this clinical trial studying?
A study testing NeuroGlove in people with Ischemic Stroke 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 5 inclusion and 7 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: withdrawn, 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Brain Function (time frame: 2 hours). 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.