Back to resultsEEG-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
About this trial
This is an interventional treatment trial for Concussion, Brain
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.
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
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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EEG-guided Cognitive Pacing Tool During Concussion Recovery
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