Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07886840

Salience Network Informed rTMS for PTSD

Conditions: Stress Disorders, Post-Traumatic

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 84
Sponsor: VA Office of Research and Development

Location: VA San Diego Healthcare System, San Diego, CA San Diego California

Summary

The proposed study will test whether magnetic resonance imaging (MRI)-guided transcranial magnetic stimulation (TMS) can reduce posttraumatic stress disorder (PTSD) symptoms in Veterans. TMS is a noninvasive treatment that uses magnetic pulses to change activity in specific areas of the brain. In this study, MRI will be used to personalize the location of TMS based on brain networks involved in detecting and responding to important or threatening information. Veterans with PTSD will be randomly assigned to receive either active or non-active control TMS over 20 sessions. The study will examine whether active TMS improves PTSD symptoms and changes the brain circuits targeted by treatment. If effective, this approach may help improve and personalize TMS treatment for Veterans with PTSD. This project supports the Department of Veterans Affairs mission of developing more effective, biologically informed treatments for Veterans with PTSD.

Eligibility Criteria

Inclusion Criteria: * Veteran status * Current diagnosis of posttraumatic stress disorder (PTSD), as determined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) * Able to provide informed consent * Able to speak, read, and write English * Willing and able to complete 20 intermittent theta burst stimulation (iTBS) treatment sessions, scheduled 5 days per week for 4 weeks, with completion permitted within up to 6 weeks when needed * Willing and able to complete magnetic resonance imaging (MRI) assessments before and after the iTBS treatment course Exclusion Criteria: * History of a neurological disorder associated with cognitive dysfunction, such as dementia or mild cognitive impairment * History of traumatic brain injury associated with an estimated loss of consciousness greater than 30 minutes * Current acute suicidal ideation or recent psychiatric hospitalization when, in the judgment of the study clinician or treating psychiatrist, the condition would interfere with safe study participation * Current psychotic disorder or bipolar disorder/mania * Current severe alcohol or substance use disorder; Mild or moderate alcohol or substance use disorder is not exclusionary * Pregnancy; less than 3 months postpartum; or less than 3 months since cessation of breastfeeding * Contraindication to magnetic resonance imaging (MRI) or transcranial magnetic stimulation (TMS), including MRI/TMS-incompatible implanted metallic or electronic devices, retained metallic foreign bodies, or other implants determined to be unsafe following MRI/TMS safety review * History of neurosurgery when incompatible with safe MRI or TMS participation * Claustrophobia that would prevent completion of MRI * Inability to lie still in the MRI scanner for approximately 60 minutes * Vision impairment that cannot be adequately corrected for completion of study procedures * Initiation of a new psychiatric medication within 4 weeks before enrollment or anticipated inability to maintain a stable medication regimen during study participation

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07886840). StuddyBuddy aggregates publicly available trial information.