Accelerated Transcranial Magnetic Stimulation Intervention for Post-Concussion Syndrome

NCT07211919 | Completed

• 2 other identifiers: CFX2025_PCS_TMS25-12-393-2253
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Post-Concussion Symptom Scale (PCSS) Score

  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.

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

• Beck Anxiety Inventory (BAI) Score

  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.

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

• Beck Depression Inventory (BDI) Score

  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.

  Pre-treatment, immediately post-treatment, and 1-4 weeks post-treatment.

• Functional Neurocognitive Imaging (fNCI) Score

  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.

  1-4 weeks pre-treatment, 1-4 weeks post-treatment

Study Arms (1)

Post-Concussion Symptom Participants

Participants experiencing chronic or acute symptoms resulting from a mild traumatic brain injury

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were primarily recruited from referrals to Neural Effects (an insurance-based acute concussion care center tied to Cognitive FX). Additional patients were recruited from word-of-mouth referrals to our clinic for concussion care.

You may qualify if:

• Chronic or acute concussion symptoms

You may not qualify if:

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

Sponsors & Collaborators

• Cognitive FX: lead

Study Sites (1)

Cognitive FX TMS Clinic

Provo, Utah, 84604, United States

Location

MeSH Terms

Conditions

Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Mark Allen, PhD

  Cognitive FX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: May 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)