Status:
UNKNOWN
Post-stroke Motor Rehabilitation Using Functional Near-infrared Spectroscopy-based Brain-computer-interface
Lead Sponsor:
Axem Neurotechnology Inc.
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Hemiparesis
Eligibility:
All Genders
18-90 years
Phase:
EARLY_PHASE1
Brief Summary
Chronic stroke survivors suffering from weaknesses or movement difficulties in their hand/arm are provided a system to aid in at-home rehabilitation for 6 weeks. This rehabilitation system includes a ...
Eligibility Criteria
Inclusion
- Age 18 - 90 years
- 6 months - 5 years since most recent stroke
- Upper-extremity Fugl-Meyer motor function (FMA-UE) score ≤56
- Able to follow simple commands
- Fluency in English
- Not currently receiving therapy for the upper extremity
Exclusion
- Visual impairment that would interfere with visualization of the therapy interface (score \>0 on the visual subscale of the NIH stroke scale)
- Montreal Cognitive Assessment (MoCA) Score ≥10
- History of significant physical disability prior to most recent stroke
- Open wounds on the scalp
- Unable or unwilling to remove hair braids or head coverings which interfere with the Axem Home device efficacy.
- Inability to follow training instructions for at-home BCI system.
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05258591
Start Date
February 23 2022
End Date
February 1 2024
Last Update
May 26 2022
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114