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

Hemiparesis Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05258591
• Other study ID #: 2020A016951
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 23, 2022
• Est. completion date: February 2024

Study information

• Verified date: May 2022
• Source: Axem Neurotechnology Inc.
• Contact: Christopher Friesen, PhD
• Phone: 2049798755
• Email: chris[@]axemneuro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiparesis
• Paresis

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Axem Neurotechnology Inc.	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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).	6 weeks
Secondary	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).	6 weeks
Secondary	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).	6 weeks
Secondary	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).	10 weeks
Secondary	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).	10 weeks