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Clinical Trials/NCT06093295
NCT06093295
Completed
N/A

Using Non-invasive Brain Stimulation to Modulate Injury Risk Biomechanics Among Individuals With and Without a Concussion History

University of Georgia1 site in 1 country40 target enrollmentNovember 3, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Concussion, Mild
Sponsor
University of Georgia
Enrollment
40
Locations
1
Primary Endpoint
Reaction Time
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to test the effects of repetitive transcranial magnetic stimulation (theta burst stimulation) on movement biomechanics (jump landing) among individuals with and without a concussion history. The main question it aims to answer is if theta burst stimulation to the left dorsolateral prefrontal cortex improves single- and dual-task jump landing reaction time and jump landing biomechanics compared to a control site (vertex) for individuals with and without a concussion history.

Participants will be asked to perform a jump landing before and after the experimental (left dorsolateral prefrontal cortex) and control (vertex) theta burst stimulation protocol. The researchers will compare individuals with and without a concussion history to see if the effects differ between groups.

Detailed Description

The overall goal of the project is to determine how repetitive transcranial magnetic stimulation (theta burst stimulation) influences movement among individuals with and without a concussion history. The purpose of this study is prevention via improving injury risk biomechanics to reduce the risk of future musculoskeletal injury. Participants will complete 2 testing sessions separated by a minimum of 7 days. During the first testing session, participants will complete single-task serial subtraction, single- and dual-task jump landing, and a theta burst stimulation intervention. The jump landing will be completed before and after theta burst stimulation and under single- and dual-task (serial 7s) conditions. During the second testing session, participants will complete the jump landing before and after theta burst stimulation under single- and dual-task (serial 7s) conditions. On both testing sessions, the symptom checklist and Tampa Scale of Kinesiophobia 11 (TSK-11) will be administered upon arrival to the lab (after informed consent on day 1), and immediately after repetitive transcranial magnetic stimulation. The Godin Leisure Activity Questionaire will be administered on both days before the jump landing. The NASA Task Load index will be administered on both days immediately after the completion of every cognitive and motor task. At the end of the second day of testing, the participants will be asked which day the participants believed the participants received the experimental and control conditions of the theta burst stimulation intervention. This is a single-blinded cross-over design study. The participants will be unaware of when the participants receive the true (experimental) and control (placebo) theta burst stimulation intervention. Experimental (left dorsolateral prefrontal cortex) and control (vertex) conditions will be counterbalanced for the concussion history group. The control group will be matched to their respective concussion history group counterpart's counterbalanced order.

Registry
clinicaltrials.gov
Start Date
November 3, 2023
End Date
May 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All participants
  • self-report to be physically active at least 90 minutes per week
  • aged 18-35 years old
  • self-report cleared for sports and physical activity
  • Concussion history group
  • self-report experiencing a concussion with the National Institute of Health common data element form
  • No concussion history group - self-report not experiencing a concussion with the National Institute of Health common data element form

Exclusion Criteria

  • All Participants
  • self-report attention deficit disorder and/or attention deficit hyperactivity disorder
  • self-report uncorrected vision problems (not included color blindness)
  • self-reported history of neurological disease
  • self-reported history of seizures/syncope or family history of epilepsy
  • self-reported history of frequent severe headaches or migraine.
  • self-reported history of respiratory or heart disease.
  • self-reported structural brain lesions (e.g., stroke)
  • self-reported increased intracranial pressure, such as after infarctions or trauma.
  • self-reported currently using antidepressants, neuroleptic medication, medication that lowers seizure threshold, or any other medication that would interfere with testing.

Outcomes

Primary Outcomes

Reaction Time

Time Frame: Immediately before and immediately after both theta burst stimulation conditions.

The time between the audible buzzer and the when sacral marker moves \>3 cm in the sagittal or transverse plane.

Knee Abduction Angle

Time Frame: Immediately before and immediately after both theta burst stimulation conditions.

The angle of the shank relative to the thigh in the frontal plane (deg).

Trunk Lateral Bending Angle

Time Frame: Immediately before and immediately after both theta burst stimulation conditions.

The angle of the trunk relative to the lab in the frontal plane (global axis system; deg)

Knee Flexion Angle

Time Frame: Immediately before and immediately after both theta burst stimulation conditions.

The angle of the shank relative to the thigh in the sagittal plane (deg).

Hip Flexion Angle

Time Frame: Immediately before and immediately after both theta burst stimulation conditions.

The angle of the thigh relative to the pelvis in the sagittal plane (deg).

Hip Adduction Angle

Time Frame: Immediately before and immediately after both theta burst stimulation conditions.

The angle of the thigh relative to the pelvis in the frontal plane (deg).

Trunk Flexion Angle

Time Frame: Immediately before and immediately after both repetitive theta burst stimulation conditions.

The angle of the trunk relative to the lab in the sagittal plane (global axis system; deg).

Secondary Outcomes

  • NASA Task Load Index(After every cognitive condition during the jump landing on both the experimental and control theta burst stimulation days.)
  • Tampa Scale of Kinesiophobia 11(Immediately before and immediately after the experimental and control theta burst stimulation.)

Study Sites (1)

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