ERP Changes Pre and Post Military Changes

NCT05474066 | Recruiting DMC FDA Device

• 1 other identifier: 2022-016
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks to investigate the cognitive effects associated with intense, military combat training regimens or so-called repetitive sub-concussive forces. Specifically, study participants will undergo cognitive testing in tandem with EEG recordings pre- and post-military training to assess cognition.

Conditions

Brain Concussion

Keywords

erp; eeg; military

Outcome Measures

Primary Outcomes (1)

• Event Related Potential Changes

  changes on selected event related potentials (ie N100, P200, N200, P300, N400) when testing attention, concentration, continuous visual memory, executive function and comprehension

  baseline and within 1 week of completion of 4 week training course

Secondary Outcomes (2)

• Impact Cognitive testing

  baseline and within 1 week of completion of 4 week training course

• VOMS

  baseline and within 1 week of completion of 4 week training course

Study Arms (1)

Pre and Post Training

A sample will be recruited from a group of 20 CAF SOF personnel ages 18-65 will be assessed twice: pre and post-special forces military training. All members enrolled in this training will be invited to participate in the study. Testing periods will be about 4 weeks apart, with post training testing within 1 week of conclusion of the exercise. Patients will be recruited from within the Canadian Special Operation Forces community. Recruitment and study will take place starting in September 2022 and continue until complete which is estimated to be approximately 12 months. Participants will be made aware of the study through recruitment letter sent as part of their training package (Appendix A). They will be allowed questions prior to enrollment or at any point during participation.

Device: ERP Testing

Interventions

ERP Testing DEVICE

* Attention \& Concentration: * Continuous Visual Memory Test (CVMT): * Flanker Task: * Hayling Test:

Pre and Post Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: man, woman and other
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A sample will be recruited from a group of 20 CAF SOF personnel ages 18-65 will be assessed twice: pre and post-special forces military training. All members enrolled in this training will be invited to participate in the study. Testing periods will be about 4 weeks apart, with post training testing within 1 week of conclusion of the exercise. Patients will be recruited from within the Canadian Special Operation Forces community

You may qualify if:

• ● Male or female between 18 and 65
• Normal or corrected to normal vision and hearing (Note: If the patient has hearing aids or wears glasses, they are still able to complete the assessment. They will need to remove hearing aids for the Attention \& Concentration and Information Processing test)
• Sit still for 10-15 minutes
• Understand basic instructions of cognitive tests

You may not qualify if:

• ● Metal plates under their scalp that cross the midline
• Taking epilepsy medications
• History of neurologic or neuropsychiatric disorder prior to concussion in controls
• Taking psychotropic medications
• History of complete deafness
• Supplements or performance enhancing drugs that can affect brain function

Sponsors & Collaborators

• Canadian Forces Health Services Centre Ottawa: lead

Study Sites (1)

Canadian Forces Health Services

Ottawa, Ontario, K0A 1B0, Canada

RECRUITING

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

• Gaurav Gupta

  Gaurav Gupta MPC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaurav Gupta

CONTACT

6139451551; gaurav.gupta@forces.gc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co Investigator

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 26, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)