Post Concussive Syndrome, ChronicNCT07211919
Accelerated Transcranial Magnetic Stimulation Intervention for Post-Concussion Syndrome
An observational study of Post Concussive Syndrome, Chronic and Post Concussion Symptoms, run by Cognitive FX at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Post Concussive Syndrome, Chronic, Post Concussion Symptoms, Post Concussive Syndrome
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Chronic or acute concussion symptoms
Who cannot join
- MDD, GAD, bipolar depression, PTSD, schizophrenia, metal implants in skull, pacemaker, history of seizures, epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional MRI Guided Accelerated Intermittent Theta Burst Stimulation for Chronic Post-Concussive Syndrome: A Feasibility and Efficacy Retrospective Chart Review
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
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-Concussion Symptom Participants | Participants experiencing chronic or acute symptoms resulting from a mild traumatic brain injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-4 weeks pre-treatment, 1-4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 May 2025
- Primary completion30 Jun 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Concussive Syndrome, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cognitive FX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Allen, PhD, Principal investigator, Cognitive FX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211919
- Sponsor's protocol ID
- CFX2025_PCS_TMS
- Other IDs
- 25-12-393-2253
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared unless other researchers sign a data use agreement outlining a plan to use IPD that does not include any form of identifiable PHI.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI Guided Accelerated Intermittent Theta Burst Stimulation for Chronic Post-Concussive Syndrome: A Feasibility and Efficacy Retrospective Chart Review
- ClinicalTrials.gov ID
- NCT07211919
- Acronym / sponsor ID
- CFX2025_PCS_TMS
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cognitive FXIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Concussion Symptom Participants | – | –Participants experiencing chronic or acute symptoms resulting from a mild traumatic brain injury |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Chronic or acute concussion symptoms
Key exclusion criteria (1 listed)
- MDD, GAD, bipolar depression, PTSD, schizophrenia, metal implants in skull, pacemaker, history of seizures, epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Individual participant dataSharing planned: No. IPD will not be shared unless other researchers sign a data use agreement outlining a plan to use IPD that does not include any form of identifiable PHI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Allen, PhD principal investigator
Cognitive FX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Concussive Syndrome, Chronic and Post Concussion Symptoms, run by Cognitive FX at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Concussion Symptom Scale (PCSS) Score (time frame: Scores taken prior to intervention, immediately post-intervention, and 1-4 weeks post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.