EEG-guided Cognitive Pacing Tool During Concussion Recovery

NCT05522855 | Unknown

• 1 other identifier: NV2022-05-002
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Concussion, Brain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Study inclusion rate and completion rate to indicate feasibility

  Baseline, post-intervention (2 weeks)

• Rivermead Post-Concussion Symptoms Questionnaire Outcomes

  12 weeks

• Change in Sports Concussion Assessment Tool score

  Baseline, post-intervention (2 weeks)

Study Arms (2)

Intervention Version- EEG Sensorband and mobile application

EXPERIMENTAL

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

Control Version- EEG Sensorband and mobile application

ACTIVE COMPARATOR

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

Interventions

EEG Sensorband and mobile application DEVICE

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.

Control Version- EEG Sensorband and mobile application; Intervention Version- EEG Sensorband and mobile application

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Matthew Kennedy: lead

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• M Kennedy

  Neurovine Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M Kennedy

CONTACT

1-844-340-0040; research@neurovine.ai

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, prospective, interventional pilot study

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 31, 2022
• Study Start: May 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share