Post Traumatic Stress DisorderNCT05916417
TMS-fNIRS Personalized Dosing
A study testing TMS-fNIRS over the dl-PFC in people with Post Traumatic Stress Disorder and Traumatic Brain Injury, run by Florida State University at 1 site in United States.
Trial summary
The intent of this study is to establish technical feasibility in a clinical population (PTSD, with or without mild TBI) of personalized TMS-fNIRS technology. Thereby demonstrating the utility of transcranial magnetic stimulation - functional near-infrared spectroscopy (TMS-fNIRS) technology as a direct measure of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Traumatic Brain Injury
- What is being tested?
- TMS-fNIRS over the dl-PFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ages 18-70 years.
- Eligible for consideration of treatment with TMS for PTSD.
- Diagnosis of PTSD based on CAPS-5.
- No changes in psychotropic medication (if taking psychotropic medication) and/or changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of study.
- Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study
Who cannot join
- Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
- Unable to have an MRI (e.g., due to ferrous metal or inability to tolerate).
- Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
- Dementia or other cognitive disorder making unable to engage in study.
- Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness.
- Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.
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- OCD cannot be the primary disorder but can have OCD symptoms
- Taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
- Current, planned, or suspected pregnancy
- Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.)
- Severe Traumatic Brain Injury
- Prior TMS treatment or already received TMS as part of a study.
- Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).
- We will exclude non-English speakers because of the need for rapid communication during the testing.
Trial locations and contacts
1 site in 1 country.
About this study
The intent of this study is to establish technical feasibility in a clinical population (PTSD, with or without mild TBI) of personalized TMS-fNIRS technology. Thereby demonstrating the utility of transcranial magnetic stimulation - functional near-infrared spectroscopy (TMS-fNIRS) technology as a direct measure of frontal brain activity, potentially replacing the indirect motor threshold procedure that may lead to improper dosing of TMS.
Personalized TMS-fNIRS technology will guide therapy for depression, post-traumatic stress disorder (PTSD), and/or traumatic brain injury (TBI)
- Being tested
- TMS-fNIRS over the dl-PFC
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS-fNIRS over the dl-PFCDevice
Transcranial Magnetic Stimulation (TMS) is a non-invasive brain stimulation technology. Functional Near Infrared Spectroscopy (fNIRS) is a brain imaging technology that utilizes light.
| Study group | Role | What they receive |
|---|---|---|
| TMS-fNIRS over the dl-PFC (Active) | Active comparator | TMS-fNIRS dl-PFC data will be acquired with participants being randomized to active or sham stimulation of the dl-PFC, with the randomizing of the order of four different TMS-fNIRS protocols. Receives: Device: TMS-fNIRS over the dl-PFC |
| TMS-fNIRS over the dl-PFC (Sham) | Sham comparator | TMS-fNIRS dl-PFC data will be acquired with participants being randomized to active or sham stimulation of the dl-PFC, with the randomizing of the order of four different TMS-fNIRS protocols. Receives: Device: TMS-fNIRS over the dl-PFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC)
The magnitude of brain activation based on fNIRS signal for the respective cortices at the individual level will be assessed and compared for the MC and dl-PFC.
Measured: Months 3-33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start19 Jan 2024
- Primary completion28 Jul 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 60 participants will be recruited and assigned to one of the two arms (active or sham TMS) at a 4:1 ratio (i.e., 48 participants for the active TMS group and 12 for the sham group). The primary outcome is the MC or dl-PFC fNIRS signal, and a total of 12 comparisons will be conducted (i.e., one test for Aim 1; one for Aim 2; and 10 for Aim 3, considering the comparisons of CNR and TDR for the four longer paradigms as well as the shorter paradigm).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, F. Andrew Kozel, Florida State University
- Investigators
- Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A., Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916417
- Sponsor's protocol ID
- STUDY00004007
- Other IDs
- CDMRP-TP220192
- Status last verified
- Aug 2026
- First submitted
- 15 May 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMS-fNIRS Personalized Dosing
- ClinicalTrials.gov ID
- NCT05916417
- Acronym / sponsor ID
- STUDY00004007
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 28 Jul 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Jun 2023 (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.
The intent of this study is to establish technical feasibility in a clinical population (PTSD, with or without mild TBI) of personalized TMS-fNIRS technology. Thereby demonstrating the utility of transcranial magnetic stimulation - functional near-infrared spectroscopy (TMS-fNIRS) technology as a direct measure of frontal brain activity, potentially replacing the indirect motor threshold procedure that may lead to improper dosing of TMS.
Personalized TMS-fNIRS technology will guide therapy for depression, post-traumatic stress disorder (PTSD), and/or traumatic brain injury (TBI)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A total of 60 participants will be recruited and assigned to one of the two arms (active or sham TMS) at a 4:1 ratio (i.e., 48 participants for the active TMS group and 12 for the sham group). The primary outcome is the MC or dl-PFC fNIRS signal, and a total of 12 comparisons will be conducted (i.e., one test for Aim 1; one for Aim 2; and 10 for Aim 3, considering the comparisons of CNR and TDR for the four longer paradigms as well as the shorter paradigm).
| Arm | Type | Receives |
|---|---|---|
| TMS-fNIRS over the dl-PFC (Active) | Active comparator | Device: TMS-fNIRS over the dl-PFCTMS-fNIRS dl-PFC data will be acquired with participants being randomized to active or sham stimulation of the dl-PFC, with the randomizing of the order of four different TMS-fNIRS protocols. |
| TMS-fNIRS over the dl-PFC (Sham) | Sham comparator | Device: TMS-fNIRS over the dl-PFCTMS-fNIRS dl-PFC data will be acquired with participants being randomized to active or sham stimulation of the dl-PFC, with the randomizing of the order of four different TMS-fNIRS protocols. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ages 18-70 years.
- Eligible for consideration of treatment with TMS for PTSD.
- Diagnosis of PTSD based on CAPS-5.
- No changes in psychotropic medication (if taking psychotropic medication) and/or changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of study.
- Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study
Key exclusion criteria (14 listed)
- Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
- Unable to have an MRI (e.g., due to ferrous metal or inability to tolerate).
- Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
- Dementia or other cognitive disorder making unable to engage in study.
- Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMS-fNIRS over the dl-PFCTranscranial Magnetic Stimulation (TMS) is a non-invasive brain stimulation technology. Functional Near Infrared Spectroscopy (fNIRS) is a brain imaging technology that utilizes light. | Device | TMS-fNIRS over the dl-PFC (Active), TMS-fNIRS over the dl-PFC (Sham) |
Primary outcome
TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC)
Time frame: Months 3-33
The magnitude of brain activation based on fNIRS signal for the respective cortices at the individual level will be assessed and compared for the MC and dl-PFC.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A. principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS-fNIRS over the dl-PFC in people with Post Traumatic Stress Disorder and Traumatic Brain Injury, run by Florida State University 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 5 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC) (time frame: Months 3-33). 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 18 Aug 2026.