Clinical trial NCT06093295: Non-invasive Brain Stimulation and Injury Risk Biomechanics
Official title: Using Non-invasive Brain Stimulation to Modulate Injury Risk Biomechanics Among Individuals With and Without a Concussion History
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Mild
Keywords: concussion
repetitive transcranial magnetic stimulation
mild traumatic brain injury
biomechanics
reaction time
theta burst stimulation
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The researchers will employ a single-blinded cross-over study design.
Primary purpose: PREVENTION

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.

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.
* 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).

Primary outcomes:
measure: Reaction Time
timeFrame: Immediately before and immediately after both theta burst stimulation conditions.
measure: Knee Flexion Angle
timeFrame: Immediately before and immediately after both theta burst stimulation conditions.
measure: Knee Abduction Angle
timeFrame: Immediately before and immediately after both theta burst stimulation conditions.
measure: Hip Flexion Angle
timeFrame: Immediately before and immediately after both theta burst stimulation conditions.
measure: Hip Adduction Angle
timeFrame: Immediately before and immediately after both theta burst stimulation conditions.
measure: Trunk Flexion Angle
timeFrame: Immediately before and immediately after both repetitive theta burst stimulation conditions.
measure: Trunk Lateral Bending Angle
timeFrame: Immediately before and immediately after both theta burst stimulation conditions.
Secondary outcomes:
measure: NASA Task Load Index
timeFrame: After every cognitive condition during the jump landing on both the experimental and control theta burst stimulation days.
measure: Tampa Scale of Kinesiophobia 11
timeFrame: Immediately before and immediately after the experimental and control theta burst stimulation.
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
Study officials:
affiliation: University of Georgia
name: Robert C Lynall, Phd, ATC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.
citation: Ngetich R, Jin D, Li W, Song B, Zhang J, Jin Z, Li L. Enhancing Visuospatial Working Memory Performance Using Intermittent Theta-Burst Stimulation Over the Right Dorsolateral Prefrontal Cortex. Front Hum Neurosci. 2022 Mar 17;16:752519. doi: 10.3389/fnhum.2022.752519. eCollection 2022.
citation: Shumski EJ, Anderson MN, Oh J, Schmidt JD, Lynall RC. Computerized and functional reaction time in varsity-level female collegiate athletes with and without a concussion history. J Sci Med Sport. 2023 Mar;26(3):189-194. doi: 10.1016/j.jsams.2023.02.008. Epub 2023 Mar 3.
citation: Lynall RC, Blackburn JT, Guskiewicz KM, Marshall SW, Plummer P, Mihalik JP. Reaction Time and Joint Kinematics During Functional Movement in Recently Concussed Individuals. Arch Phys Med Rehabil. 2018 May;99(5):880-886. doi: 10.1016/j.apmr.2017.12.011. Epub 2018 Jan 11.
citation: Said S, Gozdzik M, Roche TR, Braun J, Rossler J, Kaserer A, Spahn DR, Nothiger CB, Tscholl DW. Validation of the Raw National Aeronautics and Space Administration Task Load Index (NASA-TLX) Questionnaire to Assess Perceived Workload in Patient Monitoring Tasks: Pooled Analysis Study Using Mixed Models. J Med Internet Res. 2020 Sep 7;22(9):e19472. doi: 10.2196/19472.
citation: Chimenti RL, Post AA, Silbernagel KG, Hadlandsmyth K, Sluka KA, Moseley GL, Rio E. Kinesiophobia Severity Categories and Clinically Meaningful Symptom Change in Persons With Achilles Tendinopathy in a Cross-Sectional Study: Implications for Assessment and Willingness to Exercise. Front Pain Res (Lausanne). 2021 Sep 1;2:739051. doi: 10.3389/fpain.2021.739051. eCollection 2021.
citation: Woby SR, Roach NK, Urmston M, Watson PJ. Psychometric properties of the TSK-11: a shortened version of the Tampa Scale for Kinesiophobia. Pain. 2005 Sep;117(1-2):137-44. doi: 10.1016/j.pain.2005.05.029.