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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03858699
• Other study ID #: HTC_MScore_001
• Status: Terminated
• Start date: April 15, 2019
• Est. completion date: January 5, 2021

Study information

• Verified date: February 2021
• Source: HealthTech Connex Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: January 5, 2021
• Est. primary completion date: February 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	HealthTech Connex Centre for Neurology Studies	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
HealthTech Connex Inc.

Country where clinical trial is conducted

Canada, 

Outcome

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