Non-invasive Brain Stimulation and Injury Risk Biomechanics
- Conditions
- Concussion, Mild
- Interventions
- Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation)
- Registration Number
- NCT06093295
- Lead Sponsor
- University of Georgia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Vertex (control) Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) This is the control condition where participants will receive theta burst stimulation to the vertex. Left Dorsolateral Prefrontal Cortex (experimental) Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) This is the experimental condition where participants will receive theta burst stimulation to the left dorsolateral prefrontal cortex.
- Primary Outcome Measures
Name Time Method Reaction Time Immediately before and immediately after both theta burst stimulation conditions. The time between the audible buzzer and the when sacral marker moves \>3 cm in the sagittal or transverse plane.
Knee Abduction Angle Immediately before and immediately after both theta burst stimulation conditions. The angle of the shank relative to the thigh in the frontal plane (deg).
Trunk Lateral Bending Angle Immediately before and immediately after both theta burst stimulation conditions. The angle of the trunk relative to the lab in the frontal plane (global axis system; deg)
Hip Adduction Angle Immediately before and immediately after both theta burst stimulation conditions. The angle of the thigh relative to the pelvis in the frontal plane (deg).
Knee Flexion Angle Immediately before and immediately after both theta burst stimulation conditions. The angle of the shank relative to the thigh in the sagittal plane (deg).
Hip Flexion Angle Immediately before and immediately after both theta burst stimulation conditions. The angle of the thigh relative to the pelvis in the sagittal plane (deg).
Trunk Flexion Angle Immediately before and immediately after both repetitive theta burst stimulation conditions. The angle of the trunk relative to the lab in the sagittal plane (global axis system; deg).
- Secondary Outcome Measures
Name Time Method NASA Task Load Index After every cognitive condition during the jump landing on both the experimental and control theta burst stimulation days. 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 Immediately before and immediately after the experimental and control theta burst stimulation. 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.
Trial Locations
- Locations (1)
University of Georgia
🇺🇸Athens, Georgia, United States