Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858699
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
HealthTech Connex Inc.

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.

Condition or disease Intervention/treatment
Stroke Other: Recording of electroencephalographic (EEG) data

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Brain Vital Signs M-Score: Point-of-care Monitoring for Motor Recovery After Stroke
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

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.




Primary Outcome Measures :
  1. Resting state EEG measures [ Time Frame: 1 day ]
    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.

  2. Motor task EEG measures [ Time Frame: 1 day ]
    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.

  3. Imagery task EEG measures [ Time Frame: 1 day ]
    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.


Secondary Outcome Measures :
  1. Wolf Motor Function Test [ Time Frame: 1 day ]
    The Wolf Motor Function Test (WMFT) quantifies upper extremity motor ability using timed functional tasks.

  2. Fugl-Meyer Assessment [ Time Frame: 1 day ]
    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.

  3. Box-and-Block Test [ Time Frame: 1 day ]
    This test is used to quantify the gross manual dexterity of each hand and arm.

  4. Nine-Hole Peg Test [ Time Frame: 1 day ]
    This test is used to quantify the fine manual dexterity of each hand and arm.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858699


Contacts
Layout table for location contacts
Contact: Gabriela Pawlowski 604-639-9057 gabrielapawlowski@healthtechconnex.com

Locations
Layout table for location information
Canada, British Columbia
HealthTech Connex Centre for Neurology Studies Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Gabriela Pawlowski       gabrielapawlowski@healthtechconnex.com   
Sponsors and Collaborators
HealthTech Connex Inc.
Layout table for additonal information
Responsible Party: HealthTech Connex Inc.
ClinicalTrials.gov Identifier: NCT03858699    
Other Study ID Numbers: HTC_MScore_001
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases