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

Primary Purpose

Hemiparesis

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Axem Home
Sponsored by
Axem Neurotechnology Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Axem Home

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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).
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).

Secondary Outcome Measures

Determine whether participants can learn to modulate motor cortex brain activity during at-home BCI rehabilitation using a prototype wireless fNIRS device.
A significant difference between mean ∆HbO during either (1) the MI Task conducted at the pre-test period and MI during at-home BCI sessions conducted during week 5 and/or (2) the Motor Execution Task conducted at the pre-test ME Task and ME during at-home BCI sessions conducted during week 5 (see Statistical Methods below for more information).
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.
A significant relationship between the ability to modulate motor cortex brain activity during at-home BCI (as defined in the endpoint of secondary objective 1) and their change in FMA-UE from their pre- to post-test assessments (see Statistical Methods below for more information).
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.
A significant relationship between the ability to modulate motor cortex brain activity during at-home BCI (as defined in the endpoint of secondary objective 1) and their change in ARAT from their pre- to post-test assessments (see Statistical Methods below for more information).
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.
At least one of the significant differences in FMA-UE scores observed between the pre- and post-tests are maintained at the follow-up session (see Statistical Methods below for more information).
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.
At least one of the significant differences in ARAT scores observed between the pre- and post-tests are maintained at the follow-up session (see Statistical Methods below for more information).

Full Information

First Posted
January 18, 2022
Last Updated
May 20, 2022
Sponsor
Axem Neurotechnology Inc.
Collaborators
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05258591
Brief Title
Post-stroke Motor Rehabilitation Using Functional Near-infrared Spectroscopy-based Brain-computer-interface
Acronym
fNIRS-PROMOTE
Official Title
Portable Method of Motor Rehabilitation Using Functional Near-InfraRed Spectroscopy- Based Brain-computer-interface to Augment Post-stroke Recovery (fNIRS-PROMOTE- Recovery)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axem Neurotechnology Inc.
Collaborators
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Axem Home
Arm Type
Experimental
Arm Description
Patients receive at-home access to Axem Home system for duration of the study period.
Intervention Type
Device
Intervention Name(s)
Axem Home
Intervention Description
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 Information:
Title
Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
Description
Some participants will demonstrate a pre- to post-test increase of 6 in the Fugl-Meyer Upper-Extremity subscale.
Time Frame
6 weeks
Title
Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
Description
Some participants will demonstrate a pre- to post-test increase of 12 in the Action Research Arm Test.
Time Frame
6 weeks
Title
Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
Description
Some participants will demonstrate a pre- to post-test increase of either 0.5 in the Motor Activity Log.
Time Frame
6 weeks
Title
Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
Description
Some participants will demonstrate a pre- to post-test minimally clinically important differences the Stroke Impact Scale.
Time Frame
6 weeks
Title
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.
Description
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).
Time Frame
6 weeks
Title
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.
Description
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).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Determine whether participants can learn to modulate motor cortex brain activity during at-home BCI rehabilitation using a prototype wireless fNIRS device.
Description
A significant difference between mean ∆HbO during either (1) the MI Task conducted at the pre-test period and MI during at-home BCI sessions conducted during week 5 and/or (2) the Motor Execution Task conducted at the pre-test ME Task and ME during at-home BCI sessions conducted during week 5 (see Statistical Methods below for more information).
Time Frame
6 weeks
Title
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.
Description
A significant relationship between the ability to modulate motor cortex brain activity during at-home BCI (as defined in the endpoint of secondary objective 1) and their change in FMA-UE from their pre- to post-test assessments (see Statistical Methods below for more information).
Time Frame
6 weeks
Title
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.
Description
A significant relationship between the ability to modulate motor cortex brain activity during at-home BCI (as defined in the endpoint of secondary objective 1) and their change in ARAT from their pre- to post-test assessments (see Statistical Methods below for more information).
Time Frame
6 weeks
Title
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.
Description
At least one of the significant differences in FMA-UE scores observed between the pre- and post-tests are maintained at the follow-up session (see Statistical Methods below for more information).
Time Frame
10 weeks
Title
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.
Description
At least one of the significant differences in ARAT scores observed between the pre- and post-tests are maintained at the follow-up session (see Statistical Methods below for more information).
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Friesen, PhD
Phone
2049798755
Email
chris@axemneuro.com
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Lin, MD
Email
DLIN7@mgh.harvard.edu

12. IPD Sharing Statement

Learn more about this trial

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

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