Non-invasive Brain Stimulation and Injury Risk Biomechanics

NCT06093295 | Completed FDA Device

• 1 other identifier: PROJECT00007759
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Mild

Keywords

concussion; repetitive transcranial magnetic stimulation; mild traumatic brain injury; biomechanics; reaction time; theta burst stimulation

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• 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 Arms (2)

Left Dorsolateral Prefrontal Cortex (experimental)

EXPERIMENTAL

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)

Vertex (control)

PLACEBO COMPARATOR

This is the control condition where participants will receive theta burst stimulation to the vertex.

Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation)

Interventions

Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) DEVICE

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

Left Dorsolateral Prefrontal Cortex (experimental); Vertex (control)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Georgia: lead

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

Related Publications (7)

• 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.

  PMID: 15664172 BACKGROUND

• 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.

  PMID: 35370586 BACKGROUND

• 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.

  PMID: 36906428 BACKGROUND

• 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.

  PMID: 29337022 BACKGROUND

• 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.

  PMID: 32780712 BACKGROUND

• 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.

  PMID: 35295417 BACKGROUND

• 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.

  PMID: 16055269 BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Robert C Lynall, Phd, ATC

  University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The researchers will employ a single-blinded cross-over study design. The participant will not know which day the participant receives the true (experimental) or control (placebo) repetitive transcranial magnetic stimulation condition.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The researchers will employ a single-blinded cross-over study design.

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 23, 2023
• Study Start: November 3, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)