Using targeted TMS to improve fear extinction in PTSD patients

Neuromodulation of the Fear Extinction Circuit Using Temporally and Anatomically Specific TMS in Humans

This study is testing how different ways of using a brain stimulation technique called TMS can help people with PTSD manage their fear better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05368987 on ClinicalTrials.gov

What this trial studies

This study investigates how transcranial magnetic stimulation (TMS) can be optimized to enhance fear extinction memory in individuals with post-traumatic stress disorder (PTSD). By varying the timing and location of TMS application, researchers aim to understand its effects on brain regions involved in fear regulation. The study will involve 250 participants, including both PTSD patients and healthy controls, undergoing a series of screenings and experimental sessions over four days. The goal is to identify the most effective TMS parameters to improve fear response inhibition in PTSD patients.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with current PTSD and healthy controls without psychiatric disorders.

Not a fit: Patients with a history of significant neurological diseases, severe psychiatric disorders, or those currently using medications that lower seizure thresholds may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatments for PTSD by enhancing the brain's ability to extinguish fear responses.

How similar studies have performed: While the use of TMS in treating PTSD is being explored, this specific approach of varying timing and location is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Willing and able to provide informed consent.
* Inclusion Criteria for PTSD Subjects - Diagnosis of current PTSD
* Inclusion Criteria: Healthy Controls (HC) - no current psychiatric disorders ("Axis I" disorders)

Exclusion Criteria:

* Lifetime history of seizure or significant head trauma or other significant neurologic disease (e.g., tic disorder)
* History of serious/significant psychiatric diagnoses ("Axis I" diagnoses)
* Current significant suicidal ideation, plan or intent or suicidal behavior in past 6 months based on CSSRS and clinical judgment or Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily
* Use of neuroleptics within one year prior to study
* Current substance use
* Pregnancy (to be ruled out by urine β-HCG).
* Metallic implants or devices contraindicating magnetic resonance imaging.
* Currently taking medications that lower the seizure threshold. These include antipsychotics, high dose theophylline or stimulants such as methylphenidate. Patients taking bupropion must be on a stable dose (\*last 3 months) and take less than or equal to 300 mg/day.
* Implanted devices in subject's head (shunts, cochlear implants); metal in subject's head (other than dental implants).
* High risk of adverse emotional or behavioral reaction, and/or an inability to understand study procedures or the informed consent process
* Additional exclusion criteria for Healthy controls (HC) group: Current psychiatric diagnosis ("Axis I" diagnosis)

Where this trial is running

Houston, Texas

• UTHealth Houston — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Mohammed Milad, PhD — The University of Texas Health Science Center at Houston (UTHealth Houston)
• Study coordinator: Mohammed Milad, PhD

Conditions PTSD