fNIRS-PROMOTE: Post-stroke Motor Rehabilitation Using Functional Near-infrared Spectroscopy-based Brain-computer-interface
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Axem Home Patients receive at-home access to Axem Home system for duration of the study period. |
Device: Axem Home
Rehabilitation system comprised of functional near-infrared spectroscopy headband (measuring from the motor cortex), as well as tablet-based software application (guiding stroke survivors through rehabilitation exercises for their hands/arms).
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Outcome Measures
Primary Outcome Measures
- Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation. [6 weeks]
Some participants will demonstrate a pre- to post-test increase of 6 in the Fugl-Meyer Upper-Extremity subscale.
- Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation. [6 weeks]
Some participants will demonstrate a pre- to post-test increase of 12 in the Action Research Arm Test.
- Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation. [6 weeks]
Some participants will demonstrate a pre- to post-test increase of either 0.5 in the Motor Activity Log.
- Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation. [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. [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 FMA-UE assessment scores (see Statistical Methods below for more information).
- 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. [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 Outcome Measures
- Determine whether participants can learn to modulate motor cortex brain activity during at-home BCI rehabilitation using a prototype wireless fNIRS device. [6 weeks]
A significant difference between mean ∆HbO during either (1) the MI Task conducted at the pre-test period and MI during at-home BCI sessions conducted during week 5 and/or (2) the Motor Execution Task conducted at the pre-test ME Task and ME during at-home BCI sessions conducted during week 5 (see Statistical Methods below for more information).
- 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]
A significant relationship between the ability to modulate motor cortex brain activity during at-home BCI (as defined in the endpoint of secondary objective 1) and their change in FMA-UE from their pre- to post-test assessments (see Statistical Methods below for more information).
- 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]
A significant relationship between the ability to modulate motor cortex brain activity during at-home BCI (as defined in the endpoint of secondary objective 1) and their change in ARAT from their pre- to post-test assessments (see Statistical Methods below for more information).
- 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]
At least one of the significant differences in FMA-UE scores observed between the pre- and post-tests are maintained at the follow-up session (see Statistical Methods below for more information).
- 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]
At least one of the significant differences in ARAT scores observed between the pre- and post-tests are maintained at the follow-up session (see Statistical Methods below for more information).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 - 90 years
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6 months - 5 years since most recent stroke
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Upper-extremity Fugl-Meyer motor function (FMA-UE) score ≤56
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Able to follow simple commands
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Fluency in English
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Not currently receiving therapy for the upper extremity
Exclusion Criteria:
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Visual impairment that would interfere with visualization of the therapy interface (score >0 on the visual subscale of the NIH stroke scale)
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Montreal Cognitive Assessment (MoCA) Score ≥10
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History of significant physical disability prior to most recent stroke
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Open wounds on the scalp
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Unable or unwilling to remove hair braids or head coverings which interfere with the Axem Home device efficacy.
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Inability to follow training instructions for at-home BCI system.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Axem Neurotechnology Inc.
- Massachusetts General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020A016951