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Completed

NCT Number: NCT07211919

Accelerated Transcranial Magnetic Stimulation Intervention for Post-Concussion Syndrome

This study looks at the effects of accelerated intermittent theta burst stimulation (aiTBS) on patients with chronic and acute post-concussion syndrome. Each participant was treated in an outpatient setting for about 3 hours per day, over 3 days. The participants' symptom survey scores and brain scan data were then compared before and after treatment.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic or acute concussion symptoms

Exclusion criteria

  • MDD, GAD, bipolar depression, PTSD, schizophrenia, metal implants in skull, pacemaker, history of seizures, epilepsy

Treatment and study plan

Primary outcomes

  1. Post-Concussion Symptom Scale (PCSS) Score

    Time frame: Scores taken prior to intervention, immediately post-intervention, and 1-4 weeks post-intervention

    PCSS (post-concussion symptom scale) is a 21-question Likert scale questionnaire regarding physical, cognitive, sleep, and emotional symptoms of post-concussion syndrome. Minimum score on the scale is zero, maximum score is 126. Higher score indicates more severe symptoms.

  2. Beck Anxiety Inventory (BAI) Score

    Time frame: Immediately prior to treatment, after treatment, and 1-4 weeks post-treatment

    Beck Anxiety Inventory is a 21-question Likert scale questionnaire used for measuring severity of anxiety symptoms. Minimum score is zero, maximum score is 63. Higher score indicates more severe symptoms.

  3. Beck Depression Inventory (BDI) Score

    Time frame: Pre-treatment, immediately post-treatment, and 1-4 weeks post-treatment.

    Beck Depression Inventory is a 21-question multiple choice self-report inventory used for measuring severity of depression. Minimum score is zero, maximum score is 63. Higher scores indicate more severe symptoms.

  4. Functional Neurocognitive Imaging (fNCI) Score

    Time frame: 1-4 weeks pre-treatment, 1-4 weeks post-treatment

    The fNCI assessment protocol combines the validity of conventional neuropsychological testing standards with the reliability and objectivity of informational data output provided by fMRI. It is a scan comparing BOLD signal and blood flow from participant's brain scan against a normative database of healthy, non-injured brains. Higher scores represent further deviation from healthy baseline, with a minimum score of zero and no theoretical maximum score. Scores below 1 are within healthy range.

Sponsors and collaborators

Lead sponsor

Cognitive FX

Industry

Registry information

Official study title

Functional MRI Guided Accelerated Intermittent Theta Burst Stimulation for Chronic Post-Concussive Syndrome: A Feasibility and Efficacy Retrospective Chart Review

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2025
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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