EEG-guided Cognitive Pacing Tool During Concussion Recovery

Preliminary Efficacy of a Novel EEG-guided Cognitive Pacing Tool During Concussion Recovery: A Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Concussion, Brain
• Intervention / Treatment: Device: EEG Sensorband and mobile application

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: M Kennedy; Phone Number: 1-844-340-0040; Email: research@neurovine.ai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Version- EEG Sensorband and mobile application; 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.	Device: EEG Sensorband and mobile application; 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.
Active Comparator: Control Version- EEG Sensorband and mobile application; 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.	Device: EEG Sensorband and mobile application; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate Post-Concussion Assessment and Cognitive Testing score	Change in neurocognitive health and changes in concussion recovery. Higher score indicates improvement.	Baseline, post-intervention (2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study inclusion rate and completion rate to indicate feasibility	Rates of inclusion, deviations and completion	Baseline, post-intervention (2 weeks)
Rivermead Post-Concussion Symptoms Questionnaire Outcomes	Change in symptoms and burden of concussion. Lower score indicates improvement.	12 weeks
Change in Sports Concussion Assessment Tool score	Change in concussion symptoms. Lower score indicates improvement in symptoms.	Baseline, post-intervention (2 weeks)

Collaborators and Investigators

• Sponsor: Dr. Matthew Kennedy
• Investigators: Principal Investigator: M Kennedy, Neurovine Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: NV2022-05-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No