NeuroGlove fMRI Study

Launched by NEUROGLOVE LLC · Jul 18, 2023

Keywords

ClinConnect Summary

The NeuroGlove fMRI Study is a clinical trial that aims to explore a new treatment for people who have recently experienced a mild to moderate ischemic stroke, which is a type of stroke caused by a blockage in blood flow to the brain. In this study, 10 participants who have had a stroke will receive treatment with a device called the NeuroGlove, while 3 healthy volunteers will participate as a comparison group but will only undergo imaging tests. Overall, the study will involve a total of 13 individuals.

To be eligible for the treatment group, participants must be between 18 and 85 years old, have experienced their first stroke within the past two weeks, and show some weakness in one arm without being completely paralyzed. It's important that participants can provide their own consent and are right-hand dominant. Those in the control group also need to meet similar age and consent criteria, but they should not have any physical issues that could affect their arms. This study is not yet recruiting participants, but it promises to provide valuable insights into stroke recovery and rehabilitation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (control cohort):
• • 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.)
• Inclusion Criteria (treatment cohort):
• • 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.
• Exclusion Criteria:
• • 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.)