An interventional study of Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) in Concussion, Mild, sponsored by University of Georgia. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by University of Georgia · Not applicable, Interventional, and Prevention
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.
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.
530 studies on the registry are indexed under Brain Concussion; 152 are open to participants now.
This study's enrollment of 40 is below the median of 64 across 364 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →University of Georgia is the lead sponsor of 72 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All participants
Concussion history group
No concussion history group - self-report not experiencing a concussion with the National Institute of Health common data element form
Exclusion Criteria:
All Participants
Concussion history group
This is the experimental condition where participants will receive theta burst stimulation to the left dorsolateral prefrontal cortex.
Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation)
This is the control condition where participants will receive theta burst stimulation to the vertex.
Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation)
The repetitive transcranial magnetic stimulation device will generate successive magnetic pulses to the left dorsolateral prefrontal cortex (experimental condition) and the vertex (control condition). The theta burst stimulation protocol is as follows: * Total stimulation time \~190 seconds * Intensity: 80% of active motor threshold * 2 seconds train, repeated every 10 seconds * In every 2-second train, 3 pulses of stimulation are delivered at 50 Hz, repeated every 200 milliseconds (i.e., 5 Hz) for a total of 600 pulses
Reaction Time
The time between the audible buzzer and the when sacral marker moves \>3 cm in the sagittal or transverse plane.
Time frame: Immediately before and immediately after both theta burst stimulation conditions.
Knee Flexion Angle
The angle of the shank relative to the thigh in the sagittal plane (deg).
Time frame: Immediately before and immediately after both theta burst stimulation conditions.
Knee Abduction Angle
The angle of the shank relative to the thigh in the frontal plane (deg).
Time frame: Immediately before and immediately after both theta burst stimulation conditions.
Hip Flexion Angle
The angle of the thigh relative to the pelvis in the sagittal plane (deg).
Time frame: Immediately before and immediately after both theta burst stimulation conditions.
Hip Adduction Angle
The angle of the thigh relative to the pelvis in the frontal plane (deg).
Time frame: Immediately before and immediately after both theta burst stimulation conditions.
Trunk Flexion Angle
The angle of the trunk relative to the lab in the sagittal plane (global axis system; deg).
Time frame: Immediately before and immediately after both repetitive theta burst stimulation conditions.
Trunk Lateral Bending Angle
The angle of the trunk relative to the lab in the frontal plane (global axis system; deg)
Time frame: Immediately before and immediately after both theta burst stimulation conditions.
NASA Task Load Index
The NASA Task Load Index is abbreviated NASA-TLX. The NASA-TLX is a self-reported assessment to assess the workload and effort of a given task. There are 6 domains (mental demand, physical demand, temporal demand, performance, effort, and frustration) each scored on a scale of 0 to 20. A score of 0 indicates "very low", and a score of 20 indicates "very high". The raw scores will be summed together for analysis. Higher scores indicate greater workload and effort. The NASA-TLX will be analyzed as a continuous variable ranging from 0-120.
Time frame: After every cognitive condition during the jump landing on both the experimental and control theta burst stimulation days.
Tampa Scale of Kinesiophobia 11
The Tampa Scale of Kinesiophobia 11 (TSK-11) is a self-reported assessment to assess the participant's fear of movement. The TSK-11 ranges on a scale from 11-44. Higher scores on the TSK-11 indicate a greater fear of movement. TSK-11 will be analyzed as a continuous variable ranging from 11-44.
Time frame: Immediately before and immediately after the experimental and control theta burst stimulation.
Plan to share: No — Master data files will be available upon reasonable request.
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