Clinical trial NCT05258591: Post-stroke Motor Rehabilitation Using Functional Near-infrared Spectroscopy-based Brain-computer-interface
Official title: Portable Method of Motor Rehabilitation Using Functional Near-InfraRed Spectroscopy- Based Brain-computer-interface to Augment Post-stroke Recovery (fNIRS-PROMOTE- Recovery)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hemiparesis
Lead sponsor: Axem Neurotechnology Inc.
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
First posted: 2022-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
timeFrame: 6 weeks
measure: Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
timeFrame: 6 weeks
measure: Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
timeFrame: 6 weeks
measure: Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
Secondary outcomes:
measure: Determine whether participants can learn to modulate motor cortex brain activity during at-home BCI rehabilitation using a prototype wireless fNIRS device.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
measure: 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.
timeFrame: 10 weeks
measure: 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.
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: