Rapid treatment for PTSD using brain stimulation

Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation

This study is testing a quick brain stimulation treatment for people with PTSD to see if it can help reduce their symptoms in just one week.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Florida State University (other)
• Locations: 1 site (Tallahassee, Florida)
• Trial ID: NCT06544408 on ClinicalTrials.gov

What this trial studies

This study tests the effectiveness of an accelerated transcranial magnetic stimulation (TMS) protocol designed to quickly alleviate symptoms of PTSD over a one-week period, involving 25 treatment sessions. Participants will be randomly assigned to one of three groups: active left dl-PFC TMS, active dm-PFC TMS, or a sham treatment. Following the initial week, all participants will receive active left dl-PFC TMS in a second week, with outcomes assessed over a six-month follow-up period. The primary measure of effectiveness will be the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who meet the DSM-5 criteria for PTSD and have a PCL-5 score greater than 33.

Not a fit: Patients with medical contraindications for neuromodulation, active substance use disorders, or cognitive disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide rapid relief from PTSD symptoms, significantly improving patients' quality of life.

How similar studies have performed: Other studies have shown promise with TMS for PTSD, but this accelerated approach is relatively novel.

Eligibility criteria

Inclusion:

1. Adults age 18 years to 65 years old.
2. Meets DSM-5 criteria for PTSD with a PCL-5 score \> 33
3. No changes in psychotropic medication (if taking psychotropic medication) and/or changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of trial.
4. Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study

Exclusion:

1. Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
2. Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment.
3. Dementia or other cognitive disorder making unable to engage in treatment.
4. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness that precludes safe participation in trial.
5. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.
6. OCD cannot be the primary disorder but can have OCD symptoms.
7. Inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
8. Current, planned, or suspected pregnancy
9. Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.)
10. Severe Traumatic Brain Injury
11. We will exclude non-English speakers because of the need for rapid communication during the delivery of treatments.
12. Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).
13. Prior known active TMS of dorsolateral prefrontal cortex or dorsomedial prefrontal cortex or electroconvulsive therapy (ECT) -

Where this trial is running

Tallahassee, Florida

• Florida State University — Tallahassee, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Frank A Kozel, MD — Florida State University
• Study coordinator: Isabelle M Taylor, MA

Conditions: Post Traumatic Stress Disorder, Traumatic Brain Injury, PTSD, TMS, Transcranial Magnetic Stimulation