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Clinical Trials/NCT03858699
NCT03858699
Terminated
Not Applicable

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

HealthTech Connex Inc.1 site in 1 country22 target enrollmentApril 15, 2019
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
HealthTech Connex Inc.
Enrollment
22
Locations
1
Primary Endpoint
Motor task EEG measures
Status
Terminated
Last Updated
5 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
April 15, 2019
End Date
January 5, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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
  • 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

Outcomes

Primary Outcomes

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.

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.

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 Outcomes

  • Wolf Motor Function Test(1 day)
  • Fugl-Meyer Assessment(1 day)
  • Box-and-Block Test(1 day)
  • Nine-Hole Peg Test(1 day)

Study Sites (1)

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