NCT07463703 · Cognitive FX
Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Accelerated functional-connectivity guided transcranial magnetic stimulation
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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)
Exclusion criteria
- 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
- Aneurysm clips or coils
- Stents in the neck or brain
- 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)
Where
- Provo, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 28, 2026 · Source of record for eligibility and locations