MedPath

Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation

Not Applicable
Not yet recruiting
Conditions
Post Traumatic Stress Disorder
Traumatic 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 Criteria

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)

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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
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