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

NCT ID: NCT03858699

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2021-01-05

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. 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.

Conditions

Stroke

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Individuals with stroke

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

Recording of electroencephalographic (EEG) data

Intervention Type: 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

Even age distributions will be recruited in the adult control group, stratified under 40 years old and over 40 years old.

Recording of electroencephalographic (EEG) data

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HealthTech Connex Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HealthTech Connex Centre for Neurology Studies

Surrey, British Columbia, Canada

Countries

Canada

Other Identifiers

HTC_MScore_001

Identifier Type: -

Identifier Source: org_study_id