Post-stroke Motor Rehabilitation Using Functional Near-infrared Spectroscopy-based Brain-computer-interface

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2024-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemiparesis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Axem Home

Patients receive at-home access to Axem Home system for duration of the study period.

Group Type EXPERIMENTAL

Axem Home

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No