Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation
- Conditions
- Post Traumatic Stress DisorderTraumatic Brain Injury
- Registration Number
- NCT06544408
- Lead Sponsor
- Florida State University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 132
Inclusion:<br><br> 1. Adults age 18 years to 65 years old.<br><br> 2. Meets DSM-5 criteria for PTSD with a PCL-5 score > 33<br><br> 3. No changes in psychotropic medication (if taking psychotropic medication) and/or<br> changes in supportive psychotherapy for 1 month prior to initial visit; and<br> clinically appropriate to maintain stable treatment regimen for duration of trial.<br><br> 4. Clinically competent to give informed written consent and ability to understand<br> study procedures and to comply with them for the entire length of the study<br><br>Exclusion:<br><br> 1. Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure<br> disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).<br><br> 2. Active substance use disorder in last 3 months or any current substance use that<br> puts the participant at increased risk or significant impairment.<br><br> 3. Dementia or other cognitive disorder making unable to engage in treatment.<br><br> 4. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional<br> Disorder or other psychotic illness that precludes safe participation in trial.<br><br> 5. Suicidal risk that precludes safe participation defined as clinical impression that<br> the participant is at significant risk for suicide.<br><br> 6. OCD cannot be the primary disorder but can have OCD symptoms.<br><br> 7. Inability to stop taking any medication that significantly lowers the seizure<br> threshold (e.g., tricyclic antidepressants, clozapine, etc.)<br><br> 8. Current, planned, or suspected pregnancy<br><br> 9. Unstable medical conditions or any current medical condition that could preclude<br> being able to safely participate in TMS treatment (e.g., unstable metabolic<br> abnormality, unstable angina, etc.)<br><br> 10. Severe Traumatic Brain Injury<br><br> 11. We will exclude non-English speakers because of the need for rapid communication<br> during the delivery of treatments.<br><br> 12. Significant ongoing litigation or claims that impact research activities, as<br> determined by the research study team. (Research may especially be impacted when<br> mental health or pain is being evaluated for litigation or claims, such as civil and<br> criminal cases, disability claims and worker's compensation).<br><br> 13. Prior known active TMS of dorsolateral prefrontal cortex or dorsomedial prefrontal<br> cortex or electroconvulsive therapy (ECT)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine left dl-PFC accel-TMS efficacy;Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine dm-PFC accel-TMS efficacy;Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine superior symptom reduction
- Secondary Outcome Measures
Name Time Method Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to characterize durability of accel-TMS effects;Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine superior outcomes between active left dl-PFC and active dm-PFC accel-TMS;Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine added benefit during Extension