HemiparesisEarly Phase 1fNIRS-PROMOTENCT05258591
Post-stroke Motor Rehabilitation Using Functional Near-infrared Spectroscopy-based Brain-computer-interface
A Early Phase 1 study testing Axem Home in people with Hemiparesis, run by Axem Neurotechnology Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemiparesis
- What is being tested?
- Axem Home
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to Feb 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
David Lin, MD, DLIN7@mgh.harvard.edu
About this study
Official title: Portable Method of Motor Rehabilitation Using Functional Near-InfraRed Spectroscopy- Based Brain-computer-interface to Augment Post-stroke Recovery (fNIRS-PROMOTE- Recovery)
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
- Being tested
- Axem Home
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Axem Home | Experimental | Patients receive at-home access to Axem Home system for duration of the study period. Receives: Device: Axem Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
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).
Measured: 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.
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).
Measured: 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.
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).
Measured: 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.
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).
Measured: 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.
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).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start23 Feb 2022
- Primary completionAug 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axem Neurotechnology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258591
- Sponsor's protocol ID
- 2020A016951
- Acronym
- fNIRS-PROMOTE
- Status last verified
- May 2022
- First submitted
- 18 Jan 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portable Method of Motor Rehabilitation Using Functional Near-InfraRed Spectroscopy- Based Brain-computer-interface to Augment Post-stroke Recovery (fNIRS-PROMOTE- Recovery)
- ClinicalTrials.gov ID
- NCT05258591
- Acronym / sponsor ID
- fNIRS-PROMOTE / 2020A016951
- Conditions
- Hemiparesis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Axem Neurotechnology Inc.Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axem Home | Experimental | Device: Axem HomePatients receive at-home access to Axem Home system for duration of the study period. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axem HomeRehabilitation 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). | Device | Axem Home |
Primary outcome
Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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).
5 secondary outcomes
Determine whether participants can learn to modulate motor cortex brain activity during at-home BCI rehabilitation using a prototype wireless fNIRS device.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Axem Home in people with Hemiparesis, run by Axem Neurotechnology Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Friesen, PhD (2049798755, chris@axemneuro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation. (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.