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Non-invasive Brain Stimulation and Injury Risk Biomechanics

Primary Purpose

Concussion, Mild

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation)
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Concussion, Mild focused on measuring concussion, repetitive transcranial magnetic stimulation, mild traumatic brain injury, biomechanics, reaction time, theta burst stimulation

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Left Dorsolateral Prefrontal Cortex (experimental)

    Vertex (control)

    Arm Description

    This is the experimental condition where participants will receive theta burst stimulation to the left dorsolateral prefrontal cortex.

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

    Outcomes

    Primary Outcome Measures

    Reaction Time
    The time between the audible buzzer and the when sacral marker moves >3 cm in the sagittal or transverse plane.
    Knee Flexion Angle
    The angle of the shank relative to the thigh in the sagittal plane (deg).
    Knee Abduction Angle
    The angle of the shank relative to the thigh in the frontal plane (deg).
    Hip Flexion Angle
    The angle of the thigh relative to the pelvis in the sagittal plane (deg).
    Hip Adduction Angle
    The angle of the thigh relative to the pelvis in the frontal plane (deg).
    Trunk Flexion Angle
    The angle of the trunk relative to the lab in the sagittal plane (global axis system; deg).
    Trunk Lateral Bending Angle
    The angle of the trunk relative to the lab in the frontal plane (global axis system; deg)

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    October 11, 2023
    Last Updated
    October 16, 2023
    Sponsor
    University of Georgia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06093295
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2024 (Anticipated)
    Study Completion Date
    April 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Georgia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Concussion, Mild
    Keywords
    concussion, repetitive transcranial magnetic stimulation, mild traumatic brain injury, biomechanics, reaction time, theta burst stimulation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    The researchers will employ a single-blinded cross-over study design.
    Masking
    Participant
    Masking Description
    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.
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Left Dorsolateral Prefrontal Cortex (experimental)
    Arm Type
    Experimental
    Arm Description
    This is the experimental condition where participants will receive theta burst stimulation to the left dorsolateral prefrontal cortex.
    Arm Title
    Vertex (control)
    Arm Type
    Placebo Comparator
    Arm Description
    This is the control condition where participants will receive theta burst stimulation to the vertex.
    Intervention Type
    Device
    Intervention Name(s)
    Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation)
    Intervention Description
    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 resting 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
    Primary Outcome Measure Information:
    Title
    Reaction Time
    Description
    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.
    Title
    Knee Flexion Angle
    Description
    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.
    Title
    Knee Abduction Angle
    Description
    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.
    Title
    Hip Flexion Angle
    Description
    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.
    Title
    Hip Adduction Angle
    Description
    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.
    Title
    Trunk Flexion Angle
    Description
    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.
    Title
    Trunk Lateral Bending Angle
    Description
    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.
    Secondary Outcome Measure Information:
    Title
    NASA Task Load Index
    Description
    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.
    Title
    Tampa Scale of Kinesiophobia 11
    Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eric J Shumski, MS
    Phone
    9496902372
    Email
    eric.shumski@uga.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Robert C Lynall, PhD, ATC
    Phone
    706-542-9257
    Email
    rlynall@uga.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert C Lynall, Phd, ATC
    Organizational Affiliation
    University of Georgia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Master data files will be available upon reasonable request.
    Citations:
    PubMed Identifier
    15664172
    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.
    Results Reference
    background
    PubMed Identifier
    35370586
    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.
    Results Reference
    background
    PubMed Identifier
    36906428
    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.
    Results Reference
    background
    PubMed Identifier
    29337022
    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.
    Results Reference
    background
    PubMed Identifier
    32780712
    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.
    Results Reference
    background
    PubMed Identifier
    35295417
    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.
    Results Reference
    background
    PubMed Identifier
    16055269
    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.
    Results Reference
    background

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