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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Other: Recording of electroencephalographic (EEG) data

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
      • HealthTech Connex Centre for Neurology Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wolf Motor Function Test	The Wolf Motor Function Test (WMFT) quantifies upper extremity motor ability using timed functional tasks.	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.	1 day
Box-and-Block Test	This test is used to quantify the gross manual dexterity of each hand and arm.	1 day
Nine-Hole Peg Test	This test is used to quantify the fine manual dexterity of each hand and arm.	1 day

Collaborators and Investigators

• Sponsor: HealthTech Connex Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): February 6, 2020
• Study Completion (Actual): January 5, 2021

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HTC_MScore_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No