Recruiting
Early Phase 1

Motor Rehabilitation

Sponsor:

Axem Neurotechnology Inc.

Code:

NCT05258591

Conditions

Hemiparesis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Axem Home

Study Details

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.

Conditions

Hemiparesis

Study ID

NCT05258591

Start date

Feb 23, 2022

Status verified date

May, 2022

Completion date

Feb, 2024

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Axem Home

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

Interventions

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).

Primary outcome measure

  • Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation. [ Time Frame: 6 weeks ]
  • Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation. [ Time Frame: 6 weeks ]
  • Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation. [ Time Frame: 6 weeks ]
  • Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation. [ Time Frame: 6 weeks ]
  • 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. [ Time Frame: 6 weeks ]
  • 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. [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Christopher Friesen, PhD

2049798755chris@axemneuro.com

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

David Lin, MD

DLIN7@mgh.harvard.edu

More Information

Sponsor

Axem Neurotechnology Inc.

Last update posted

May 26, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Axem Neurotechnology Inc. on 2022-05-26.