StrokeNCT03858699
Brain Vital Signs M-Score: Point-of-care Monitoring for Motor Recovery After Stroke
An observational study of Stroke, run by HealthTech Connex Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to investigate brain signals relating to motor function, using electroencephalography (EEG) technology. The aims of the study can be separated into 3 specific study objectives: 1. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Recording of electroencephalographic (EEG) data
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2019to 5 Jan 2021
- Phase
- Observational
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Number of Participants: Up to 30 healthy participants and 30 individuals with stroke.
Who may be able to join
- Age requirements:
- Younger adult control participants (19-40 years old)
- Older adult control participants (41-80 years old)
- Individuals with stroke (19-80 years old)
- Capacity to follow single stage commands
- Stroke specific inclusion criteria
- Upper-limb disability as a result of a stroke (>1 month ago)
Who cannot join
- Cognitive difficulties that undermine ability to give informed consent (Montreal Cognitive Assessment (MoCA) score below 23).
- Severe paralysis such that the participant cannot perform simple movements (such as finger tapping, clicking a mouse, etc.)
- History of head trauma, a major psychiatric diagnosis, neurodegenerative disorder or substance abuse
Trial locations and contacts
1 site in 1 country.
Canada1 site
HealthTech Connex Centre for Neurology Studies
Surrey, British Columbia, V3V 1Z2
About this study
The purpose of this study is to investigate brain signals relating to motor function, using electroencephalography (EEG) technology. The aims of the study can be separated into 3 specific study objectives:
- Record EEG data from control participants and individuals with stroke during basic motor tasks and build a database of EEG signals to enable analysis of motor control.
- Apply signal processing algorithms to extract EEG features related to motor control.
- Develop a framework/the motor score (M-Score) that uses the EEG signals, in combination with machine learning approaches, to quantify motor control ability.
- Conditions
- Stroke
- Being tested
- Recording of electroencephalographic (EEG) data
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of electroencephalographic (EEG) dataOther
Non-invasive brain activity will be measured with electroencephalography (EEG). EEG uses scalp sensors to monitor the brain's electrical activity. EEG sensors are placed on the scalp and passively record neural activity with high time resolution.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with stroke | Participants in sub-acute and chronic phases post-stroke (>1 month post-stroke) will be recruited for participation in this study. Receives: Other: Recording of electroencephalographic (EEG) data | |
| Adult control participants | Even age distributions will be recruited in the adult control group, stratified under 40 years old and over 40 years old. Receives: Other: Recording of electroencephalographic (EEG) data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting state EEG measures
EEG uses scalp sensors to monitor the brain's electrical activity. EEG sensors are placed on the scalp and passively record neural activity with high time resolution. The principal recording system for this study will be a 32-channel g.Nautilus EEG system (g.tec medical engineering). Secondary recording systems may be used: 8-channel g.Nautilus EEG system (g.tec medical engineering) and 64-channel, high-density BrainAmp EEG system (BrainProducts).Participants will be seated while wearing the EEG cap and asked to sit quietly with either eyes open (with a fixation dot or cross to reduce eye movements) or eyes closed. Resting state recordings will be approximately 5-10 minutes in length.
Measured: 1 day
Motor task EEG measures
While completing EEG scans, participants will be asked to execute simple motor movements. . Study will focus on finger tapping task (with mouse-like button for recording movement timing). Participants will be asked to complete self-paced movements with approximately 10-15 second inter-trial spacing. Recording will occur in two-minute intervals, followed by a rest period, repeated until approximately 40 trials have been collected. Other motor movements, such as flexion of the upper limbs or flexion of the lower limbs, may also be considered. During EEG recordings changes in motor oscillations (alpha, beta, \& gamma range) will be analyzed. During EMG recordings, muscle tonicity/spasticity and functional firing patterns will be analyzed.
Measured: 1 day
Imagery task EEG measures
During EEG recording participants could be asked to engage in mental imagery of motor movements stated above. Here, potential changes in oscillatory patterns in the motor cortex will be measured and detected.
Measured: 1 day
Secondary outcomes (4)
Wolf Motor Function Test
The Wolf Motor Function Test (WMFT) quantifies upper extremity motor ability using timed functional tasks.
Measured: 1 day
Fugl-Meyer Assessment
The Fugl-Meyer Assessment (FMA) is a performance-based impairment index designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Measured: 1 day
Box-and-Block Test
This test is used to quantify the gross manual dexterity of each hand and arm.
Measured: 1 day
Nine-Hole Peg Test
This test is used to quantify the fine manual dexterity of each hand and arm.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start15 Apr 2019
- Primary completion6 Feb 2020
- Study completion5 Jan 2021
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthTech Connex Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858699
- Sponsor's protocol ID
- HTC_MScore_001
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Vital Signs M-Score: Point-of-care Monitoring for Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT03858699
- Acronym / sponsor ID
- HTC_MScore_001
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 22 participants (actual)
- Lead sponsor
- HealthTech Connex Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 1 Mar 2019 (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.
The purpose of this study is to investigate brain signals relating to motor function, using electroencephalography (EEG) technology. The aims of the study can be separated into 3 specific study objectives:
- Record EEG data from control participants and individuals with stroke during basic motor tasks and build a database of EEG signals to enable analysis of motor control.
- Apply signal processing algorithms to extract EEG features related to motor control.
- Develop a framework/the motor score (M-Score) that uses the EEG signals, in combination with machine learning approaches, to quantify motor control ability.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with stroke | – | Other: Recording of electroencephalographic (EEG) dataParticipants in sub-acute and chronic phases post-stroke (>1 month post-stroke) will be recruited for participation in this study. |
| Adult control participants | – | Other: Recording of electroencephalographic (EEG) dataEven age distributions will be recruited in the adult control group, stratified under 40 years old and over 40 years old. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Number of Participants: Up to 30 healthy participants and 30 individuals with stroke.
Key inclusion criteria (7 listed)
- Age requirements:
- Capacity to follow single stage commands
- Stroke specific inclusion criteria
Key exclusion criteria (3 listed)
- Cognitive difficulties that undermine ability to give informed consent (Montreal Cognitive Assessment (MoCA) score below 23).
- Severe paralysis such that the participant cannot perform simple movements (such as finger tapping, clicking a mouse, etc.)
- History of head trauma, a major psychiatric diagnosis, neurodegenerative disorder or substance abuse
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 |
|---|---|---|
| Recording of electroencephalographic (EEG) dataNon-invasive brain activity will be measured with electroencephalography (EEG). EEG uses scalp sensors to monitor the brain's electrical activity. EEG sensors are placed on the scalp and passively record neural activity with high time resolution. | Other | Adult control participants, Individuals with stroke |
Primary outcome
Resting state EEG measures
Time frame: 1 day
EEG uses scalp sensors to monitor the brain's electrical activity. EEG sensors are placed on the scalp and passively record neural activity with high time resolution. The principal recording system for this study will be a 32-channel g.Nautilus EEG system (g.tec medical engineering). Secondary recording systems may be used: 8-channel g.Nautilus EEG system (g.tec medical engineering) and 64-channel, high-density BrainAmp EEG system (BrainProducts).Participants will be seated while wearing the EEG cap and asked to sit quietly with either eyes open (with a fixation dot or cross to reduce eye movements) or eyes closed. Resting state recordings will be approximately 5-10 minutes in length.
Motor task EEG measures
Time frame: 1 day
While completing EEG scans, participants will be asked to execute simple motor movements. . Study will focus on finger tapping task (with mouse-like button for recording movement timing). Participants will be asked to complete self-paced movements with approximately 10-15 second inter-trial spacing. Recording will occur in two-minute intervals, followed by a rest period, repeated until approximately 40 trials have been collected. Other motor movements, such as flexion of the upper limbs or flexion of the lower limbs, may also be considered. During EEG recordings changes in motor oscillations (alpha, beta, \& gamma range) will be analyzed. During EMG recordings, muscle tonicity/spasticity and functional firing patterns will be analyzed.
Imagery task EEG measures
Time frame: 1 day
During EEG recording participants could be asked to engage in mental imagery of motor movements stated above. Here, potential changes in oscillatory patterns in the motor cortex will be measured and detected.
4 secondary outcomes
Wolf Motor Function Test
Time frame: 1 day
Fugl-Meyer Assessment
Time frame: 1 day
Box-and-Block Test
Time frame: 1 day
Nine-Hole Peg Test
Time frame: 1 day
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by HealthTech Connex Inc. at 1 site in Canada.
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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 10 Feb 2021. 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 Canada. 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.
Are results available for this study?
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting state EEG measures (time frame: 1 day). The study lists 3 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 10 Feb 2021.