NCT05258591

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

1.4 years

First QC Date

January 18, 2022

Last Update Submit

May 20, 2022

Conditions

Hemiparesis

Outcome Measures

Primary Outcomes (6)

  • Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.

    Some participants will demonstrate a pre- to post-test increase of 6 in the Fugl-Meyer Upper-Extremity subscale.

    6 weeks

  • Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.

    Some participants will demonstrate a pre- to post-test increase of 12 in the Action Research Arm Test.

    6 weeks

  • Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.

    Some participants will demonstrate a pre- to post-test increase of either 0.5 in the Motor Activity Log.

    6 weeks

  • Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.

    Some participants will demonstrate a pre- to post-test minimally clinically important differences the Stroke Impact Scale.

    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.

    Significant differences between responders and non-responders (as defined in the endpoint of primary objective 1) in fNIRS measures taken either during pre-test fNIRS tasks or at-home BCI sessions which are not accounted for by pre-test FMA-UE assessment scores (see Statistical Methods below for more information).

    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.

    Significant differences between responders and non-responders (as defined in the endpoint of primary objective 1) in fNIRS measures taken either during pre-test fNIRS tasks or at-home BCI sessions which are not accounted for by pre-test ARAT assessment scores (see Statistical Methods below for more information).

    6 weeks

Secondary Outcomes (5)

  • Determine whether participants can learn to modulate motor cortex brain activity during at-home BCI rehabilitation using a prototype wireless fNIRS device.

    6 weeks

  • 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.

    6 weeks

  • 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.

    6 weeks

  • 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.

    10 weeks

  • 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.

    10 weeks

Study Arms (1)

Axem Home

EXPERIMENTAL

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

Device: Axem Home

Interventions

Axem HomeDEVICE

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).

Axem Home

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 - 90 years
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Christopher Friesen, PhD

CONTACT

2049798755chris@axemneuro.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 28, 2022

Study Start

February 23, 2022

Primary Completion

August 1, 2023

Study Completion

February 1, 2024

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations

US(1)