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TerminatedNCT03858699Updated Feb 10, 2021

Brain Vital Signs M-Score: Point-of-care Monitoring for Motor Recovery After Stroke

An observational study in Stroke, sponsored by HealthTech Connex Inc.. Terminated at 1 site in Canada. Open to participants aged 19 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-10.

Sponsored by HealthTech Connex Inc. · Observational

Why this study was terminated
low recruitment
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
22
Ages
19 Years to 80 Years
Sex
All
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Study 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. 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.
  2. Apply signal processing algorithms to extract EEG features related to motor control.
  3. Develop a framework/the motor score (M-Score) that uses the EEG signals, in combination with machine learning approaches, to quantify motor control ability.
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Conditions studied

  • Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 22 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

HealthTech Connex Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Number of Participants: Up to 30 healthy participants and 30 individuals with stroke.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
22 participants (actual)
Patient registry
No

Groups and cohorts

  • Individuals with stroke

    Participants in sub-acute and chronic phases post-stroke (\>1 month post-stroke) will be recruited for participation in this study.

    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.

    Other: Recording of electroencephalographic (EEG) data

Interventions

  • OtherRecording of electroencephalographic (EEG) data

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

  3. 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.

    Time frame: 1 day

Secondary outcomes

  1. Wolf Motor Function Test

    The Wolf Motor Function Test (WMFT) quantifies upper extremity motor ability using timed functional tasks.

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

  3. Box-and-Block Test

    This test is used to quantify the gross manual dexterity of each hand and arm.

    Time frame: 1 day

  4. Nine-Hole Peg Test

    This test is used to quantify the fine manual dexterity of each hand and arm.

    Time frame: 1 day

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Study locations

1 site
  • HealthTech Connex Centre for Neurology Studies
    Surrey, British Columbia V3V 1Z2, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03858699
Lead sponsor
HealthTech Connex Inc.
Responsible party
Sponsor
First posted
Mar 1, 2019
Start date
Apr 15, 2019
Primary completion
Feb 6, 2020
Completion
Jan 5, 2021
Last update
Feb 10, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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