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

Last updated: May 20, 2022
Sponsor: Axem Neurotechnology Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05258591
2020A016951
  • Ages 18-90
  • All Genders

Study 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

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

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 theAxem Home device efficacy.
  • Inability to follow training instructions for at-home BCI system.

Study Design

Total Participants: 40
Study Start date:
February 23, 2022
Estimated Completion Date:
February 29, 2024

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.