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Clinical Trials/ACTRN12621001355864
ACTRN12621001355864
Completed
未知

Investigating the neural effects of subconcussive head impacts in athletes: A pilot RCT using advanced neuroimaging techniques

niversity of Sydney0 sites15 target enrollmentOctober 7, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Subconcussive Head Impacts
Sponsor
niversity of Sydney
Enrollment
15
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 7, 2021
End Date
November 4, 2022
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Healthy individuals
  • \- More than or equal to 5 years of soccer heading experience; that is, more than or equal to 5 full seasons of play and(or) training (with heading) the most recent of which was completed in the last 2 years.
  • \- Proficient in English and able to provide informed consent

Exclusion Criteria

  • (a)A self\-reported head, neck, face and/or eye injury (including concussion; as assessed via the Concussion History Questionnaire in the last 12 months
  • (b)A current, self\-reported sports injury (any type)
  • (c)A self\-reported history of neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness \>15\-minutes, spinal cord injury, stroke)
  • (d)Implantation of a cochlear device, cardiac pacemaker, intracardiac lines, medical fusion device, neurostimulator or metal plates (in the head)
  • (e)Use of dental braces or eyeglasses (contact lenses permitted)
  • (f)A contraindication to MRI (that is not already excluded in another criterion) (i.e., body and(or) facial piercings that cannot easily be removed, a drug infusion pump that cannot easily be removed)
  • (g)A history of a major psychiatric disorder within the previous 12 months, as per the Diagnostic and Statistical Manual of Mental Disorders (DSM)\-V criteria or at the medical doctor’s discretion, except, mild to moderate depression (score \<20 on the Beck Depression Inventory \[BDI] or mild to moderate anxiety (score \<16 on the Beck Anxiety Inventory \[BAI]
  • (h)A history of attempted suicide or current suicide ideation as determined by a score \>0 on Question 9 of the Patient Health Questionnaire (PHQ)\-9
  • (i)Inability to avoid soccer heading or any other activity involving head impacts (e.g., contact sports) 7\-days prior to and while participating in this project
  • (j)Inability to refrain from consuming alcohol (24 hours) and caffeine (12 hours) prior to each experimental trial

Outcomes

Primary Outcomes

Not specified

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