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NCT07886840

Salience Network Informed rTMS for PTSD

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Official title: Salience Network-guided rTMS for Veterans With PTSD

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-07-01

Completion Date

2031-03-31

Last Updated

2026-10-27

Healthy Volunteers

Conditions

Stress Disorders, Post-Traumatic

Interventions

DEVICE

Active MRI-Guided intermittent theta burst stimulation (iTBS)

Active intermittent theta burst stimulation (iTBS) will be delivered using the MagVenture TMS Therapy System. An individualized right dorsolateral prefrontal cortex treatment target will be identified using MRI/fMRI-based functional connectivity with the right anterior insula of the salience network. The Brainsight neuronavigation system will be used to localize the individualized target and guide TMS coil positioning. Each treatment session will consist of 600 pulses. Participants will receive 20 treatment sessions, scheduled 5 days per week for 4 weeks. When needed because of scheduling interruptions, the 20 sessions may be completed within up to 6 weeks.

DEVICE

Sham MRI-Guided intermittent theta burst stimulation (iTBS)

Sham intermittent theta burst stimulation (iTBS) will be delivered using the MagVenture TMS Therapy System. An individualized right dorsolateral prefrontal cortex treatment target will be identified using MRI/fMRI-based functional connectivity with the right anterior insula of the salience network. The Brainsight neuronavigation system will be used to localize the individualized target and guide TMS coil positioning. Sham stimulation will use the same treatment location, session structure, and treatment schedule as the active condition and is designed to mimic the treatment experience without delivering active therapeutic stimulation. Participants will receive 20 sham treatment sessions, scheduled 5 days per week for 4 weeks. When needed because of scheduling interruptions, the 20 sessions may be completed within up to 6 weeks.

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

Locations (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States