Recruiting

Observational Study

Sponsor:

Canadian Forces Health Services Centre Ottawa

Code:

NCT05474066

Conditions

Brain Concussion

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ERP Testing

Study Details

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

Study ID

NCT05474066

Start date

Aug 1, 2022

Status verified date

Feb, 2024

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Aug 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ● 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

Exclusion Criteria:

  • ● 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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

ERP Testing

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

Primary outcome measure

  • Event Related Potential Changes [ Time Frame: baseline and within 1 week of completion of 4 week training course ]

Central Contacts and Locations

Central contacts

Gaurav Gupta

6139451551gaurav.gupta@forces.gc.ca

Locations

Canadian Forces Health Services

Recruiting

Ottawa, Ontario, Canada, K0A 1B0

Contacts

Gaurav Gupta

6139451551gaurav.gupta@forces.gc.ca

More Information

Sponsor

Canadian Forces Health Services Centre Ottawa

Last update posted

Feb 13, 2024

Last verified

Feb, 2024

Keywords

  • erp
  • eeg
  • military

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Forces Health Services Centre Ottawa on 2024-02-13.