Post-stroke Motor Rehabilitation Using Functional Near-infrared Spectroscopy-based Brain-computer-interface (fNIRS-PROMOTE)

Axem Neurotechnology

Status and phase

Unknown

Early Phase 1

Conditions

Hemiparesis

Treatments

Device: Axem Home

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05258591

2020A016951

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.