Non-invasive Brain Stimulation and Injury Risk Biomechanics

Concussion, Mild Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06093295
• Other study ID #: PROJECT00007759
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: March 2024
• Source: University of Georgia
• Contact: Eric J Shumski, MS
• Phone: 9496902372
• Email: eric.shumski[@]uga.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Mild

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation)
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

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University of Georgia

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.