What is the mechanism of action of this treatment?

Repetitive Transcranial Magnetic Stimulation (rTMS), including Theta Burst Stimulation (TBS) to the Left Dorsolateral Prefrontal Cortex, works by using magnetic fields to stimulate nerve cells in the brain. This stimulation can modulate neural activity, potentially enhancing neuroplasticity and improving cognitive and motor functions. For Traumatic Brain Injury (TBI) patients, this is significant because it offers a non-invasive method to promote brain recovery and mitigate symptoms such as impaired motor skills and cognitive deficits. By targeting specific brain regions, rTMS can help restore functional connectivity and support rehabilitation efforts.

What side effects are associated with this type of intervention?

Repetitive transcranial magnetic stimulation (rTMS) and theta burst stimulation (TBS) are non-invasive neuromodulation techniques used in various neurological and psychiatric conditions, including traumatic brain injury (TBI). Common side effects of these treatments include mild headaches, scalp discomfort at the stimulation site, and transient dizziness. Serious adverse events are rare but can include the risk of inducing seizures, particularly in individuals with a predisposition to epilepsy. Overall, these treatments are generally well-tolerated with a favorable safety profile.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for Traumatic Brain Injury (TBI) that are similar to Repetitive Transcranial Magnetic Stimulation (rTMS) with Theta Burst Stimulation. While rTMS has shown promise in treating conditions like depression and is being explored for TBI, it has not yet received FDA approval for this specific use. Other neuromodulation techniques, such as vagus nerve stimulation and deep brain stimulation, are also being investigated but are not FDA-approved for TBI treatment.

What other types of research exist?

Promising, novel alternatives to Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) for TBI patients include Transcranial Direct Current Stimulation (tDCS), Vagus Nerve Stimulation (VNS), and Cranial Electrotherapy Stimulation (CES). These methods have shown potential in improving cognitive and neuropsychological outcomes in various neurological conditions and are being explored for TBI treatment.

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Non-invasive Brain Stimulation for Concussion

N/A

Recruiting

Led By Robert C Lynall, Phd, ATC

Research Sponsored by University of Georgia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All participants aged 18-35 years old

Be between 18 and 65 years old

Must not have

All Participants self-reported history of neurological disease

All Participants self-reported history of seizures/syncope or family history of epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately before and immediately after both repetitive theta burst stimulation conditions.

Summary

This trial tests if using magnetic pulses on a specific brain area can improve movement and reduce injury risk in people with and without past concussions. The goal is to see if this treatment helps them perform physical tasks better.

Who is the study for?

This trial is for active individuals aged 18-35, cleared for sports, with or without a past concussion. Excluded are those with ADHD, uncorrected vision issues, neurological diseases, seizures, severe headaches/migraines, heart/respiratory disease, brain lesions/increased intracranial pressure; using certain medications; pregnant; having metal/electronic implants in the head; not medically cleared for physical activity.

What is being tested?

The study tests if theta burst stimulation to the prefrontal cortex can improve reaction time and biomechanics during jump landing tasks compared to control stimulation at the vertex. It looks at differences between people with and without a history of concussion.

What are the potential side effects?

While not explicitly stated here, side effects of transcranial magnetic stimulation may include headache, scalp discomfort at the site of stimulation, tingling or spasms in facial muscles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of neurological disease.

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I or someone in my family has a history of seizures or epilepsy.

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I have experienced increased pressure in my brain due to injury or stroke.

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I am currently taking antidepressants or other medications that could affect the study.

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I am currently on medication to suppress my immune system.

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I often have severe headaches or migraines.

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I have a history of heart or lung disease.

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I currently have a high fever over 102.9 degrees.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately before and immediately after both theta burst stimulation conditions.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately before and immediately after both theta burst stimulation conditions.

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately before and immediately after both theta burst stimulation conditions. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hip Adduction Angle

Hip Flexion Angle

Knee Abduction Angle

+4 more

Secondary study objectives

NASA Task Load Index

Tampa Scale of Kinesiophobia 11

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Left Dorsolateral Prefrontal Cortex (experimental)Experimental Treatment1 Intervention

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

Group II: Vertex (control)Placebo Group1 Intervention

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Repetitive Transcranial Magnetic Stimulation (rTMS), including Theta Burst Stimulation (TBS) to the Left Dorsolateral Prefrontal Cortex, works by using magnetic fields to stimulate nerve cells in the brain. This stimulation can modulate neural activity, potentially enhancing neuroplasticity and improving cognitive and motor functions. For Traumatic Brain Injury (TBI) patients, this is significant because it offers a non-invasive method to promote brain recovery and mitigate symptoms such as impaired motor skills and cognitive deficits. By targeting specific brain regions, rTMS can help restore functional connectivity and support rehabilitation efforts.