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Accelerated Transcranial Magnetic Stimulation Intervention for Post-Concussion Syndrome

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07211919
Enrollment
11
Registered
2025-10-08
Start date
2025-05-01
Completion date
2025-07-31
Last updated
2025-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorder Not Otherwise Specified, Post Concussion Symptoms, Post Concussion Syndrome, Post Concussive Syndrome, Post Concussive Syndrome, Chronic

Keywords

Post Concussion Syndrome, fMRI Transcranial Magnetic Stimulation, Accelerated Intermittent Theta Burst, Functional Neuroimaging

Brief summary

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.

Interventions

None listed

Sponsors

Cognitive FX
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Chronic or acute concussion symptoms

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Post-Concussion Symptom Scale (PCSS) ScoreScores taken prior to intervention, immediately post-intervention, and 1-4 weeks post-interventionPCSS (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.
Beck Anxiety Inventory (BAI) ScoreImmediately prior to treatment, after treatment, and 1-4 weeks post-treatmentBeck 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.
Beck Depression Inventory (BDI) ScorePre-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.
Functional Neurocognitive Imaging (fNCI) Score1-4 weeks pre-treatment, 1-4 weeks post-treatmentThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026