PTSD - Post Traumatic Stress DisorderNCT07463703
Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder
A study testing Accelerated functional-connectivity guided transcranial magnetic stimulation in people with PTSD - Post Traumatic Stress Disorder, run by Cognitive FX at 1 site in United States.
Trial summary
This study tests a new brain stimulation treatment for post-traumatic stress disorder (PTSD), a condition that affects millions after trauma, causing symptoms like flashbacks, avoidance, mood changes, and heightened alertness. The investigators will enroll 15 adults (ages 18-65) with PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Accelerated functional-connectivity guided transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2026to Jan 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet ALL of the following criteria:
- Age 18-65 years (inclusive)
- DSM-5 diagnosis of PTSD confirmed by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
- PCL-5 total score ≥33 (indicating at least moderate symptom severity)
- PTSD symptom duration ≥3 months
- If taking psychotropic medications, stable dose for ≥6 weeks prior to enrollment with no planned changes during study participation
Show all 10Show fewer
- Able to provide written informed consent
- English-speaking (required for validated assessment measures)
- Able to attend daily treatment sessions for 5 consecutive weekdays
- Eligible for 1.5T MRI scanning (no contraindications)
Who cannot join
- Participants meeting ANY of the following criteria will be excluded:
- TMS Contraindications:
- Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head or within 30 cm of the TMS coil (excluding the mouth), including:
- Cochlear implants
- Deep brain stimulators
- Vagus nerve stimulators
Show all 31Show fewer
- Aneurysm clips or coils
- Stents in the neck or brain
- Electrodes
- Any implanted electronic devices
- History of seizure disorder (excluding single childhood febrile seizure)
- First-degree family member with epilepsy
- History of significant head trauma with loss of consciousness >10 minutes
- History of stroke, brain tumor, or other neurological disorder
- Neurosurgical procedures involving brain tissue
- MRI Contraindications:
- Implanted medical devices incompatible with MRI
- Claustrophobia preventing MRI scan completion
- Body size preventing MRI scanner entry
- Psychiatric Exclusions:
- Lifetime history of psychotic disorder (schizophrenia, schizoaffective disorder, delusional disorder)
- Lifetime history of bipolar I disorder
- Current (within past month) moderate or severe substance use disorder per DSM-5 criteria
- Current active suicidal ideation with intent or plan (Columbia Suicide Severity Rating Scale score ≥4)
- Psychiatric hospitalization within past 3 months
- Medical Exclusions:
- Unstable medical condition that, in the investigator's judgment, would interfere with study participation or pose safety risk
- Pregnancy or breastfeeding (females of childbearing potential must have negative urine pregnancy test at screening)
- Prior TMS treatment within past 3 months
- Current participation in another interventional research study
- Initiation of psychotherapy specifically for PTSD within past 3 months (stable ongoing therapy is permitted)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mark Allen, PhD contact
United States1 site, 1 recruiting
- Recruiting
Cognitive FX TMS Clinic
Provo, Utah, 84604
About this study
Official title: Feasibility and Preliminary Efficacy of Functional MRI-Guided Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder: A Pilot Study
This study tests a new brain stimulation treatment for post-traumatic stress disorder (PTSD), a condition that affects millions after trauma, causing symptoms like flashbacks, avoidance, mood changes, and heightened alertness.
The investigators will enroll 15 adults (ages 18-65) with PTSD. First, participants get a brain scan (fMRI) to map their unique brain connections between areas involved in fear and control-the right amygdala (fear center) and right dorsolateral prefrontal cortex (control area). Using this personalized map, the investigators will apply accelerated transcranial magnetic stimulation (TMS), a safe, non-invasive method using magnetic pulses to adjust brain activity. Treatment lasts 5 days (10 short sessions daily, totaling 90,000 pulses) targeting the identified spot to strengthen control over fear responses.
Read more
The study checks if this approach is practical, safe (tracking side effects like headaches), and shows early signs of reducing PTSD symptoms (measured by questionnaires and interviews). Follow-up lasts 3 months, with repeat scans to see brain changes.
This study will see if personalized, fast-paced TMS targeting the disrupted fear-control brain circuit in PTSD can be feasible and safe, and preliminarily reduce symptoms by improving brain connectivity, potentially offering a quicker alternative to standard treatments.
Read the detailed description
This pilot study evaluates the feasibility, safety, and preliminary efficacy of functional magnetic resonance imaging (fMRI)-guided accelerated continuous theta burst stimulation (cTBS) targeting the right dorsolateral prefrontal cortex (rDLPFC) in adults with post-traumatic stress disorder (PTSD). PTSD is characterized by dysregulation in the fear circuitry, including amygdala hyperreactivity and impaired prefrontal regulation, leading to persistent symptoms despite standard treatments like trauma-focused psychotherapy or selective serotonin reuptake inhibitors, which achieve adequate response in only about 50% of patients.
The intervention leverages resting-state fMRI to identify individualized rDLPFC targets based on maximal positive functional connectivity to the right amygdala, addressing inter-individual variability in circuit topography (average 4.5 cm variation per recent literature). Imaging is acquired on a 1.5T scanner with T1-weighted structural (MPRAGE: TR=1645 ms, TE=3.8 ms, voxel=0.8 mm isotropic) and resting-state functional sequences (EPI: TR=2000 ms, TE=40 ms, voxel=3.75×3.75×4 mm, 900 volumes). Data processing via FSL includes motion correction, spatial smoothing (5 mm FWHM), bandpass filtering (0.01-0.1 Hz), and nuisance regression. The peak correlation voxel in the rDLPFC (Brodmann areas 8,9,10,46) serves as the target; fallback to MNI [40,28,44] if data quality fails.
Treatment employs an accelerated cTBS protocol over 5 consecutive days (50 sessions total: 10/day, 1,800 pulses/session, 90,000 pulses overall) using ANT Visor 2 neuronavigation for precise coil positioning. Each session delivers bursts of 3 pulses at 50 Hz, repeated at 5 Hz for 40 seconds (600 pulses/train), with 3 trains and 30-second inter-train intervals, at 65-80% resting motor threshold (determined via EMG over the first dorsal interosseous). Inter-session intervals are 50 minutes, with continuous monitoring for adverse events.
The single-arm, open-label design includes a screening/baseline phase (informed consent, medical history, safety screenings), baseline fMRI for targeting, treatment phase with daily safety checks, post-treatment assessments (within 48-72 hours), and follow-ups at 1 and 3 months. Total participant commitment is ~3.5 months. Pre- and post-treatment fMRI explores mechanistic changes in rDLPFC-amygdala connectivity (seed-to-seed Pearson correlation, Fisher z-transformed) and target shifts (Euclidean distance, component decomposition), correlating with clinical improvements.
This approach combines precision neuromodulation with accelerated delivery to reduce treatment burden (5 days vs. 4-6 weeks standard), building on meta-analyses showing moderate-to-large TMS effects in PTSD (SMD=1.02) and FDA-cleared neuroimaging-guided protocols like SAINT. The study aims to generate proof-of-concept data for larger randomized trials, focusing on circuit-specific modulation to enhance fear extinction and prefrontal control. Safety is prioritized with strict contraindication screening, real-time monitoring, and an independent safety monitor reviewing serious adverse events.
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Being tested
- Accelerated functional-connectivity guided transcranial magnetic stimulation
- Keywords
- Post Traumatic Stress Disorder
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated functional-connectivity guided transcranial magnetic stimulationDevice
Resting state functional connectivity scanning will be used to identify the peak positive correlate of the right amygdala in the right dorsolateral prefrontal cortex. This target will be stimulated during 50 sessions over 5 days, 10 sessions per day. Each TMS session will consist of 3 trains of 600-pulse continuous theta burst stimulation (cTBS). Each train consists of 3-pulse 50-Hz bursts at 5-Hz for 40-second trains, with trains every 70 seconds. This stimulation will be applied at 80% of the patient's resting motor threshold. Target site will be identified using ANT Neuro Visor2 neuronavigation system.
| Study group | Role | What they receive |
|---|---|---|
| Active accelerated TMS stimulation | Experimental | This is a single-arm, open-label pilot study. All enrolled participants will receive active fMRI-guided accelerated cTBS treatment to the right dorsolateral prefrontal cortex (rDLPFC). The study includes a screening/baseline phase, a 5-day treatment phase, and a 3-month follow-up phase. Receives: Device: Accelerated functional-connectivity guided transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5)
A change in PTSD severity will be measured via administration of the PDSD Checklist for DSM-5 (PCL-5). This is a 20-question Likert scale, with scores ranging from 0 to 80. Higher scores indicate stronger PTSD symptoms.
Measured: Baseline, post-treatment 5 days, 1 month, 3 months
Secondary outcomes (4)
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is the gold-standard PTSD assessment. It is a 30-item structured interview that can assess PTSD symptoms over the past week, as well as make current or lifetime diagnoses of PTSD. We will measure change in CAPS-5 score between baseline and 5 days post-treatment.
Measured: Baseline, post-treatment 5 days, 3 months
Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory-II (BDI-II) is a 21-question self-report survey measuring the severity of depression in adolescents and adults.
Measured: Baseline, post-treatment 5 days, 1 month, 3 months
Patient Global Impression of Change (PGI-C)
7-point self-reported instrument that measures a patient's belief about the efficacy of a treatment
Measured: Post-treatment 5 days, 3 months
Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia Suicide Severity Rating Scale (C-SSRS) is a standardized clinical tool used to identify and assess the risk of suicide. It isn't scored with a single total number but by interpreting "Yes/No" answers to identify risk levels (low, moderate, high) and specific suicidal ideation/behavior categories, with positive answers to later questions (like intent, specific plans, or preparatory acts) indicating higher, immediate risk requiring urgent intervention.
Measured: Baseline, treatment days 1, 2, 3, 4, and 5, post-treatment 5 days, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start14 Aug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cognitive FX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463703
- Sponsor's protocol ID
- COMPASS-PTSD-1.0.0
- Status last verified
- Jul 2026
- First submitted
- 2 Mar 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All individual participant data underlying the text, tables, figures, and appendices reported in this trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of Functional MRI-Guided Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT07463703
- Acronym / sponsor ID
- COMPASS-PTSD-1.0.0
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cognitive FXIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 11 Mar 2026 (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 tests a new brain stimulation treatment for post-traumatic stress disorder (PTSD), a condition that affects millions after trauma, causing symptoms like flashbacks, avoidance, mood changes, and heightened alertness.
The investigators will enroll 15 adults (ages 18-65) with PTSD. First, participants get a brain scan (fMRI) to map their unique brain connections between areas involved in fear and control-the right amygdala (fear center) and right dorsolateral prefrontal cortex (control area). Using this personalized map, the investigators will apply accelerated transcranial magnetic stimulation (TMS), a safe, non-invasive method using magnetic pulses to adjust brain activity. Treatment lasts 5 days (10 short sessions daily, totaling 90,000 pulses) targeting the identified spot to strengthen control over fear responses.
The study checks if this approach is practical, safe (tracking side effects like headaches), and shows early signs of reducing PTSD symptoms (measured by questionnaires and interviews). Follow-up lasts 3 months, with repeat scans to see brain changes.
This study will see if personalized, fast-paced TMS targeting the disrupted fear-control brain circuit in PTSD can be feasible and safe, and preliminarily reduce symptoms by improving brain connectivity, potentially offering a quicker alternative to standard treatments.
Detailed description
This pilot study evaluates the feasibility, safety, and preliminary efficacy of functional magnetic resonance imaging (fMRI)-guided accelerated continuous theta burst stimulation (cTBS) targeting the right dorsolateral prefrontal cortex (rDLPFC) in adults with post-traumatic stress disorder (PTSD). PTSD is characterized by dysregulation in the fear circuitry, including amygdala hyperreactivity and impaired prefrontal regulation, leading to persistent symptoms despite standard treatments like trauma-focused psychotherapy or selective serotonin reuptake inhibitors, which achieve adequate response in only about 50% of patients.
The intervention leverages resting-state fMRI to identify individualized rDLPFC targets based on maximal positive functional connectivity to the right amygdala, addressing inter-individual variability in circuit topography (average 4.5 cm variation per recent literature). Imaging is acquired on a 1.5T scanner with T1-weighted structural (MPRAGE: TR=1645 ms, TE=3.8 ms, voxel=0.8 mm isotropic) and resting-state functional sequences (EPI: TR=2000 ms, TE=40 ms, voxel=3.75×3.75×4 mm, 900 volumes). Data processing via FSL includes motion correction, spatial smoothing (5 mm FWHM), bandpass filtering (0.01-0.1 Hz), and nuisance regression. The peak correlation voxel in the rDLPFC (Brodmann areas 8,9,10,46) serves as the target; fallback to MNI [40,28,44] if data quality fails.
Treatment employs an accelerated cTBS protocol over 5 consecutive days (50 sessions total: 10/day, 1,800 pulses/session, 90,000 pulses overall) using ANT Visor 2 neuronavigation for precise coil positioning. Each session delivers bursts of 3 pulses at 50 Hz, repeated at 5 Hz for 40 seconds (600 pulses/train), with 3 trains and 30-second inter-train intervals, at 65-80% resting motor threshold (determined via EMG over the first dorsal interosseous). Inter-session intervals are 50 minutes, with continuous monitoring for adverse events.
The single-arm, open-label design includes a screening/baseline phase (informed consent, medical history, safety screenings), baseline fMRI for targeting, treatment phase with daily safety checks, post-treatment assessments (within 48-72 hours), and follow-ups at 1 and 3 months. Total participant commitment is ~3.5 months. Pre- and post-treatment fMRI explores mechanistic changes in rDLPFC-amygdala connectivity (seed-to-seed Pearson correlation, Fisher z-transformed) and target shifts (Euclidean distance, component decomposition), correlating with clinical improvements.
This approach combines precision neuromodulation with accelerated delivery to reduce treatment burden (5 days vs. 4-6 weeks standard), building on meta-analyses showing moderate-to-large TMS effects in PTSD (SMD=1.02) and FDA-cleared neuroimaging-guided protocols like SAINT. The study aims to generate proof-of-concept data for larger randomized trials, focusing on circuit-specific modulation to enhance fear extinction and prefrontal control. Safety is prioritized with strict contraindication screening, real-time monitoring, and an independent safety monitor reviewing serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active accelerated TMS stimulation | Experimental | Device: Accelerated functional-connectivity guided transcranial magnetic stimulationThis is a single-arm, open-label pilot study. All enrolled participants will receive active fMRI-guided accelerated cTBS treatment to the right dorsolateral prefrontal cortex (rDLPFC). The study includes a screening/baseline phase, a 5-day treatment phase, and a 3-month follow-up phase. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-65 years (inclusive)
- DSM-5 diagnosis of PTSD confirmed by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
- PCL-5 total score ≥33 (indicating at least moderate symptom severity)
- PTSD symptom duration ≥3 months
- If taking psychotropic medications, stable dose for ≥6 weeks prior to enrollment with no planned changes during study participation
Key exclusion criteria (31 listed)
- Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head or within 30 cm of the TMS coil (excluding the mouth), including:
- History of seizure disorder (excluding single childhood febrile seizure)
- First-degree family member with epilepsy
- History of significant head trauma with loss of consciousness >10 minutes
- History of stroke, brain tumor, or other neurological disorder
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 |
|---|---|---|
| Accelerated functional-connectivity guided transcranial magnetic stimulationResting state functional connectivity scanning will be used to identify the peak positive correlate of the right amygdala in the right dorsolateral prefrontal cortex. This target will be stimulated during 50 sessions over 5 days, 10 sessions per day. Each TMS session will consist of 3 trains of 600-pulse continuous theta burst stimulation (cTBS). Each train consists of 3-pulse 50-Hz bursts at 5-Hz for 40-second trains, with trains every 70 seconds. This stimulation will be applied at 80% of the patient's resting motor threshold. Target site will be identified using ANT Neuro Visor2 neuronavigation system. | Device | Active accelerated TMS stimulation |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline, post-treatment 5 days, 1 month, 3 months
A change in PTSD severity will be measured via administration of the PDSD Checklist for DSM-5 (PCL-5). This is a 20-question Likert scale, with scores ranging from 0 to 80. Higher scores indicate stronger PTSD symptoms.
4 secondary outcomes
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Baseline, post-treatment 5 days, 3 months
Beck Depression Inventory-II (BDI-II)
Time frame: Baseline, post-treatment 5 days, 1 month, 3 months
Patient Global Impression of Change (PGI-C)
Time frame: Post-treatment 5 days, 3 months
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, treatment days 1, 2, 3, 4, and 5, post-treatment 5 days, 1 month, 3 months
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 28 Jul 2026.
- Individual participant dataSharing planned: Yes. All individual participant data underlying the text, tables, figures, and appendices reported in this trial, after deidentification.
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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.
Mark Allen, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated functional-connectivity guided transcranial magnetic stimulation in people with PTSD - Post Traumatic Stress Disorder, 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 10 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 28 Jul 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. 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?
Contact Lynn Gaufin, MD (385-446-4158, tms.info@cognitivefxusa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (time frame: Baseline, post-treatment 5 days, 1 month, 3 months). 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 28 Jul 2026.