Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation

Launched by FLORIDA STATE UNIVERSITY · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat Post-Traumatic Stress Disorder (PTSD) using a method called accelerated Transcranial Magnetic Stimulation (TMS). The goal is to see if this treatment can quickly reduce PTSD symptoms in just one week, with participants receiving 25 sessions over five days. This research is open to adults aged 18 to 65 who meet specific criteria for PTSD, meaning they have symptoms that seriously affect their daily life.

To be part of the study, participants should not have any serious medical conditions that would make TMS unsafe for them, such as having metal in the head or a history of certain mental illnesses. They should also be stable on their current medications and not have used any drugs or alcohol recently that could interfere with treatment. If eligible, participants can expect to undergo a series of non-invasive treatments that do not require anesthesia and have minimal side effects. This trial may be a valuable opportunity for those seeking rapid relief from PTSD symptoms.

Gender

ALL

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) -