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

NCT03858699 | Terminated

• 1 other identifier: HTC_MScore_001
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Apply signal processing algorithms to extract EEG features related to motor control.
3. 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Wolf Motor Function Test

  1 day

• Fugl-Meyer Assessment

  1 day

• Box-and-Block Test

  1 day

• Nine-Hole Peg Test

  1 day

Study Arms (2)

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

Recording of electroencephalographic (EEG) data OTHER

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; Individuals with stroke

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• Upper-limb disability as a result of a stroke (\>1 month ago)

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthTech Connex Inc.: lead

Study Sites (1)

HealthTech Connex Centre for Neurology Studies

Surrey, British Columbia, V3V 1Z2, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 1, 2019
• Study Start: April 15, 2019
• Primary Completion: February 6, 2020
• Study Completion: January 5, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)