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EEG-guided Cognitive Pacing Tool During Concussion Recovery

Primary Purpose

Concussion, Brain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EEG Sensorband and mobile application
Sponsored by
Dr. Matthew Kennedy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion, Brain

Eligibility Criteria

16 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals are eligible to participate if they meet all of the following criteria:

  • has been diagnosed with a concussion within previous 6 weeks;
  • are between >16 and <55 years of age;
  • fluent in English;
  • able to attend the baseline testing session within 6 weeks post-injury;
  • willing and able to comply with the requirements of the study protocol, including use of intervention;
  • able to access a desktop computer or laptop with a colour monitor, reliable internet connection, pointing device,(mouse or trackpad), and modern web browser for administration of ImPACT Version 4.

Exclusion Criteria: Individuals are ineligible to participate if they meet any of the following criteria:

  • do not have access to a desktop computer or laptop with the technical requirements to perform ImPACT testing at their home (as described above);
  • uncontrolled epilepsy (seizure within 6 months), uncontrolled chronic recurrent migraines, or other neurological disorders that may interfere with concussion recovery and assessment;
  • any signs of dementia or other pre-existing cognitive impairment that would prevent them from giving free, informed consent;
  • have an implantable electrical device;
  • any evidence of the following in addition to concussion diagnosis:

    • documentation that the concussion they had sustained was associated with a Glasgow Coma Scale score ≤ 12 (if available),
    • any findings of trauma on neuroimaging such as brain contusion or hematoma (if available), and
    • any evidence of skull fractures of bony injuries that would require additional rehabilitation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention Version- EEG Sensorband and mobile application

    Control Version- EEG Sensorband and mobile application

    Arm Description

    EEG headband to record brain signals. The Sensorband uses Bluetooth to link to the mobile application on a user's device. This raw EEG data is processed on a HIPPA compliant cloud based server and displays mental workload and brain energy data on the application. This can help the user with cognitive pacing to avoid overexertion.

    EEG headband to record brain signals. The Sensorband uses Bluetooth to link to the mobile application on a user's device. This raw EEG data is processed on a HIPPA compliant cloud based server like the Intervention version, but no mental workload or brain energy data will be displayed.

    Outcomes

    Primary Outcome Measures

    Immediate Post-Concussion Assessment and Cognitive Testing score
    Change in neurocognitive health and changes in concussion recovery. Higher score indicates improvement.

    Secondary Outcome Measures

    Study inclusion rate and completion rate to indicate feasibility
    Rates of inclusion, deviations and completion
    Rivermead Post-Concussion Symptoms Questionnaire Outcomes
    Change in symptoms and burden of concussion. Lower score indicates improvement.
    Change in Sports Concussion Assessment Tool score
    Change in concussion symptoms. Lower score indicates improvement in symptoms.

    Full Information

    First Posted
    August 25, 2022
    Last Updated
    March 23, 2023
    Sponsor
    Dr. Matthew Kennedy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05522855
    Brief Title
    EEG-guided Cognitive Pacing Tool During Concussion Recovery
    Official Title
    Preliminary Efficacy of a Novel EEG-guided Cognitive Pacing Tool During Concussion Recovery: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr. Matthew Kennedy

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This investigation will assess the utility of a novel wearable electroencephalography (EEG) headband linked to a mobile application to monitor cognitive activity post-concussion, and alert a patient when it is time to take a mental break. Personalized cloud-based machine learning algorithms will analyze EEG data in real-time for neural features indicative of mental workload and mental fatigue, and will notify a patient when it is time to rest based on these measures. It is hypothesized that this technology may provide a much needed data-driven management tool to better inform the cognitive pacing process for both patients with concussion, as well as their clinicians.
    Detailed Description
    Despite advancements in the field of concussion care, the individualized nature and nuances of concussion make it a difficult condition to manage. It has been shown that both complete rest or too much activity can prolong recovery from concussion, indicating there is an ideal zone of activity that can aid in concussion recovery. Heart-rate guided sub-symptom aerobic physical activity has been shown to speed concussion recovery and provide an objective measure for patients with concussion to inform their rehabilitative physical activities. However, no such equal exists for guiding cognitive pacing. This study will utilize a wearable EEG headband linked to a mobile application to monitor cognitive activity post-concussion, and alert a patient when it is time to take a mental break. Personalized cloud-based machine learning algorithms will analyze EEG data in real-time for neural features of mental workload and mental fatigue, and will notify a patient when it is time to rest based on these measures. These algorithms have been developed and validated on healthy participants, and refined in concussion patients in an ongoing observational investigation yet to be published. The proposed investigation is a randomized, prospective pilot study to test the early efficacy of this technology in concussion recovery compared to standard of care alone. The results of this pilot investigation will be used to inform a future large-scale clinical trial to confirm the efficacy of this technology on concussion recovery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Concussion, Brain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized, prospective, interventional pilot study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Version- EEG Sensorband and mobile application
    Arm Type
    Experimental
    Arm Description
    EEG headband to record brain signals. The Sensorband uses Bluetooth to link to the mobile application on a user's device. This raw EEG data is processed on a HIPPA compliant cloud based server and displays mental workload and brain energy data on the application. This can help the user with cognitive pacing to avoid overexertion.
    Arm Title
    Control Version- EEG Sensorband and mobile application
    Arm Type
    Active Comparator
    Arm Description
    EEG headband to record brain signals. The Sensorband uses Bluetooth to link to the mobile application on a user's device. This raw EEG data is processed on a HIPPA compliant cloud based server like the Intervention version, but no mental workload or brain energy data will be displayed.
    Intervention Type
    Device
    Intervention Name(s)
    EEG Sensorband and mobile application
    Intervention Description
    EEG headband to record brain signals. The Sensorband uses Bluetooth to link to the mobile application on a user's device. This raw EEG data is processed on a HIPPA compliant cloud based server and displays mental workload and brain energy data on the application. This can help the user with cognitive pacing to avoid overexertion. The control version will not display mental workload and brain energy data on the application.
    Primary Outcome Measure Information:
    Title
    Immediate Post-Concussion Assessment and Cognitive Testing score
    Description
    Change in neurocognitive health and changes in concussion recovery. Higher score indicates improvement.
    Time Frame
    Baseline, post-intervention (2 weeks)
    Secondary Outcome Measure Information:
    Title
    Study inclusion rate and completion rate to indicate feasibility
    Description
    Rates of inclusion, deviations and completion
    Time Frame
    Baseline, post-intervention (2 weeks)
    Title
    Rivermead Post-Concussion Symptoms Questionnaire Outcomes
    Description
    Change in symptoms and burden of concussion. Lower score indicates improvement.
    Time Frame
    12 weeks
    Title
    Change in Sports Concussion Assessment Tool score
    Description
    Change in concussion symptoms. Lower score indicates improvement in symptoms.
    Time Frame
    Baseline, post-intervention (2 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Individuals are eligible to participate if they meet all of the following criteria: has been diagnosed with a concussion within previous 6 weeks; are between >16 and <55 years of age; fluent in English; able to attend the baseline testing session within 6 weeks post-injury; willing and able to comply with the requirements of the study protocol, including use of intervention; able to access a desktop computer or laptop with a colour monitor, reliable internet connection, pointing device,(mouse or trackpad), and modern web browser for administration of ImPACT Version 4. Exclusion Criteria: Individuals are ineligible to participate if they meet any of the following criteria: do not have access to a desktop computer or laptop with the technical requirements to perform ImPACT testing at their home (as described above); uncontrolled epilepsy (seizure within 6 months), uncontrolled chronic recurrent migraines, or other neurological disorders that may interfere with concussion recovery and assessment; any signs of dementia or other pre-existing cognitive impairment that would prevent them from giving free, informed consent; have an implantable electrical device; any evidence of the following in addition to concussion diagnosis: documentation that the concussion they had sustained was associated with a Glasgow Coma Scale score ≤ 12 (if available), any findings of trauma on neuroimaging such as brain contusion or hematoma (if available), and any evidence of skull fractures of bony injuries that would require additional rehabilitation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    M Kennedy
    Phone
    1-844-340-0040
    Email
    research@neurovine.ai
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    M Kennedy
    Organizational Affiliation
    Neurovine Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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