Non-invasive Brain Stimulation and Injury Risk Biomechanics

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Concussion, Mild

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation)


Participation Criteria
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Eligibility Criteria
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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. self-reported currently experiencing a high fever (day of testing; >102.9 degrees) self-reported currently undergoing immunosuppressive therapy pregnancy metal anywhere in the head (except the mouth). any electronic implant, such as a cardiac pacemakers, cochlear implant, or deep brain stimulator. any implanted medication pump or intracardiac lines. self-report not being cleared for sport/physical activity by a medical practitioner (i.e., must be cleared by a medical practitioner to participate if the participant had previous traumatic musculoskeletal injury) students working directly in the PI's lab (concussion laboratory, biomechanics laboratory) NCAA athletes Concussion history group - ≥13 symptom severity on the Sport Concussion Assessment Tool (22 total symptoms are graded on a scale of 0-6. Any symptom with a score >0 [1-6], is summed to get symptom severity).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The researchers will employ a single-blinded cross-over study design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left Dorsolateral Prefrontal Cortex (experimental)<br>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)<br>* 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<br>|
| Placebo Comparator: Vertex (control)<br>This is the control condition where participants will receive theta burst stimulation to the vertex. | Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction Time | The time between the audible buzzer and the when sacral marker moves >3 cm in the sagittal or transverse plane. | 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). | 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). | 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). | 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). | 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). | 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) | Immediately before and immediately after both theta burst stimulation conditions. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Immediately before and immediately after the experimental and control theta burst stimulation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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concussion, repetitive transcranial magnetic stimulation, mild traumatic brain injury, biomechanics, reaction time, theta burst stimulation