Concussion, BrainNCT05522855
EEG-guided Cognitive Pacing Tool During Concussion Recovery
A study testing EEG Sensorband and mobile application in people with Concussion, Brain, run by Dr. Matthew Kennedy.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- EEG Sensorband and mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Concussion, Brain
- Being tested
- EEG Sensorband and mobile application
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG Sensorband and mobile applicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: EEG Sensorband and mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Post-Concussion Assessment and Cognitive Testing score
Change in neurocognitive health and changes in concussion recovery. Higher score indicates improvement.
Measured: Baseline, post-intervention (2 weeks)
Secondary outcomes (3)
Study inclusion rate and completion rate to indicate feasibility
Rates of inclusion, deviations and completion
Measured: Baseline, post-intervention (2 weeks)
Rivermead Post-Concussion Symptoms Questionnaire Outcomes
Change in symptoms and burden of concussion. Lower score indicates improvement.
Measured: 12 weeks
Change in Sports Concussion Assessment Tool score
Change in concussion symptoms. Lower score indicates improvement in symptoms.
Measured: Baseline, post-intervention (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study startMay 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, prospective, interventional pilot study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Matthew Kennedy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Dr. Matthew Kennedy, Neurovine Inc.
- Investigators
- M Kennedy, Principal investigator, Neurovine Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522855
- Sponsor's protocol ID
- NV2022-05-002
- Status last verified
- Mar 2023
- First submitted
- 25 Aug 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy of a Novel EEG-guided Cognitive Pacing Tool During Concussion Recovery: A Pilot Study
- ClinicalTrials.gov ID
- NCT05522855
- Acronym / sponsor ID
- NV2022-05-002
- Conditions
- Concussion, Brain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dr. Matthew KennedyIndustry (pharma, biotech, devices)
- Study start
- May 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, prospective, interventional pilot study
| Arm | Type | Receives |
|---|---|---|
| Intervention Version- EEG Sensorband and mobile application | Experimental | Device: EEG Sensorband and mobile applicationEEG 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. |
| Control Version- EEG Sensorband and mobile application | Active comparator | Device: EEG Sensorband and mobile applicationEEG 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. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG Sensorband and mobile applicationEEG 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. | Device | Control Version- EEG Sensorband and mobile application, Intervention Version- EEG Sensorband and mobile application |
Primary outcome
Immediate Post-Concussion Assessment and Cognitive Testing score
Time frame: Baseline, post-intervention (2 weeks)
Change in neurocognitive health and changes in concussion recovery. Higher score indicates improvement.
3 secondary outcomes
Study inclusion rate and completion rate to indicate feasibility
Time frame: Baseline, post-intervention (2 weeks)
Rivermead Post-Concussion Symptoms Questionnaire Outcomes
Time frame: 12 weeks
Change in Sports Concussion Assessment Tool score
Time frame: Baseline, post-intervention (2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M Kennedy principal investigator
Neurovine Inc.
Questions about this trial
What is this clinical trial studying?
A study testing EEG Sensorband and mobile application in people with Concussion, Brain, run by Dr. Matthew Kennedy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M Kennedy (1-844-340-0040, research@neurovine.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Post-Concussion Assessment and Cognitive Testing score (time frame: Baseline, post-intervention (2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.