Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07463703
Eligibility Criteria:
Inclusion Criteria
Participants must meet ALL of the following criteria:
1. Age 18-65 years (inclusive)
2. DSM-5 diagnosis of PTSD confirmed by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
3. PCL-5 total score ≥33 (indicating at least moderate symptom severity)
4. PTSD symptom duration ≥3 months
5. If taking psychotropic medications, stable dose for ≥6 weeks prior to enrollment with no planned changes during study participation
6. Able to provide written informed consent
7. English-speaking (required for validated assessment measures)
8. Able to attend daily treatment sessions for 5 consecutive weekdays
9. Eligible for 1.5T MRI scanning (no contraindications)
Exclusion Criteria
Participants meeting ANY of the following criteria will be excluded:
TMS Contraindications:
1. 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
* Electrodes
* Any implanted electronic devices
2. History of seizure disorder (excluding single childhood febrile seizure)
3. First-degree family member with epilepsy
4. History of significant head trauma with loss of consciousness \>10 minutes
5. History of stroke, brain tumor, or other neurological disorder
6. Neurosurgical procedures involving brain tissue
MRI Contraindications:
1. Implanted medical devices incompatible with MRI
2. Claustrophobia preventing MRI scan completion
3. Body size preventing MRI scanner entry
Psychiatric Exclusions:
1. Lifetime history of psychotic disorder (schizophrenia, schizoaffective disorder, delusional disorder)
2. Lifetime history of bipolar I disorder
3. Current (within past month) moderate or severe substance use disorder per DSM-5 criteria
4. Current active suicidal ideation with intent or plan (Columbia Suicide Severity Rating Scale score ≥4)
5. Psychiatric hospitalization within past 3 months
Medical Exclusions:
6. Unstable medical condition that, in the investigator's judgment, would interfere with study participation or pose safety risk
7. Pregnancy or breastfeeding (females of childbearing potential must have negative urine pregnancy test at screening)
8. Prior TMS treatment within past 3 months
9. Current participation in another interventional research study
10. Initiation of psychotherapy specifically for PTSD within past 3 months (stable ongoing therapy is permitted)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07463703
Study Brief:
Protocol Section:
NCT07463703