Portable Method of Motor Rehabilitation Using Functional Near-InfraRed Spectroscopy- Based Brain-computer-interface to Augment Post-stroke Recovery (fNIRS-PROMOTE- Recovery)
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Hemiparesis
- Sponsor
- Axem Neurotechnology Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
- Last Updated
- 3 years ago
Overview
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 headband that measures and provides feedback from the brain during rehabilitation, together with tablet-based software. Throughout the 6 week rehabilitation period (as well as in a follow-up session 1 month afterwards) several assessments are taken to understand the effect of this rehabilitation on participant's movement abilities, as well as their brain activity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
Time Frame: 6 weeks
Some participants will demonstrate a pre- to post-test minimally clinically important differences the Stroke Impact Scale.
Determine when in the course of the study (if at all) fNIRS data contains predictive information regarding the likelihood that participants would respond to at-home BCI rehabilitation.
Time Frame: 6 weeks
Significant differences between responders and non-responders (as defined in the endpoint of primary objective 1) in fNIRS measures taken either during pre-test fNIRS tasks or at-home BCI sessions which are not accounted for by pre-test ARAT assessment scores (see Statistical Methods below for more information).
Secondary Outcomes
- If any of primary objectives 1-4 are met, show that the improvements in function achieved by responders to at-home BCI rehabilitation is maintained after the at-home BCI rehabilitation is discontinued.(10 weeks)
- Determine whether participants can learn to modulate motor cortex brain activity during at-home BCI rehabilitation using a prototype wireless fNIRS device.(6 weeks)
- If secondary objective 1 is met, determine whether learning to modulate motor cortex brain activity during at-home BCI rehabilitation increases the likelihood of benefitting from at-home BCI rehabilitation.(6 weeks)