AzTrials
AzTrials

Concussion, MildNCT06093295

Non-invasive Brain Stimulation and Injury Risk Biomechanics

A study testing Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) in people with Concussion, Mild, run by University of Georgia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Concussion, Mild
What is being tested?
Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
3 Nov 2023to 30 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 21Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Georgia

    Athens, Georgia, 30602

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation)
Keywords
concussion, repetitive transcranial magnetic stimulation, mild traumatic brain injury, biomechanics, reaction time, theta burst stimulation
Medical subject headings
Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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
Study groups in NCT06093295
Study groupRoleWhat they receive
Left Dorsolateral Prefrontal Cortex (experimental)ExperimentalThis is the experimental condition where participants will receive theta burst stimulation to the left dorsolateral prefrontal cortex.
Receives: Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation)
Vertex (control)Placebo comparatorThis is the control condition where participants will receive theta burst stimulation to the vertex.
Receives: Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reaction Time

    The time between the audible buzzer and the when sacral marker moves >3 cm in the sagittal or transverse plane.

    Measured: Immediately before and immediately after both theta burst stimulation conditions.

  2. Knee Flexion Angle

    The angle of the shank relative to the thigh in the sagittal plane (deg).

    Measured: Immediately before and immediately after both theta burst stimulation conditions.

  3. Knee Abduction Angle

    The angle of the shank relative to the thigh in the frontal plane (deg).

    Measured: Immediately before and immediately after both theta burst stimulation conditions.

  4. Hip Flexion Angle

    The angle of the thigh relative to the pelvis in the sagittal plane (deg).

    Measured: Immediately before and immediately after both theta burst stimulation conditions.

  5. Hip Adduction Angle

    The angle of the thigh relative to the pelvis in the frontal plane (deg).

    Measured: Immediately before and immediately after both theta burst stimulation conditions.

  6. Trunk Flexion Angle

    The angle of the trunk relative to the lab in the sagittal plane (global axis system; deg).

    Measured: Immediately before and immediately after both repetitive theta burst stimulation conditions.

  7. Trunk Lateral Bending Angle

    The angle of the trunk relative to the lab in the frontal plane (global axis system; deg)

    Measured: Immediately before and immediately after both theta burst stimulation conditions.

Secondary outcomes (2)
  1. 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.

    Measured: After every cognitive condition during the jump landing on both the experimental and control theta burst stimulation days.

  2. 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.

    Measured: Immediately before and immediately after the experimental and control theta burst stimulation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start3 Nov 2023
  3. Primary completion30 May 2024
  4. Study completion30 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Crossover
Model description
The researchers will employ a single-blinded cross-over study design.
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06093295
Sponsor's protocol ID
PROJECT00007759
Status last verified
Jan 2025
First submitted
11 Oct 2023
Last updated
9 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Master data files will be available upon reasonable request.

Publications

  • 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.

    PubMed 15664172
  • 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.

    PubMed 35370586
  • 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.

    PubMed 36906428
  • 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.

    PubMed 29337022
  • 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.

    PubMed 32780712
  • 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.

    PubMed 35295417
  • 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.

    PubMed 16055269

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) in people with Concussion, Mild, run by University of Georgia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reaction Time (time frame: Immediately before and immediately after both theta burst stimulation conditions.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06093295, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in