Targeting the Default Mode Network: A TMS-fMRI Study

NCT05646732 | Recruiting

• 2 other identifiers: ROANEW_0004MH129799
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In post-traumatic stress disorder (PTSD), intrusive, traumatic, autobiographical memories lead to anxiety symptoms. Recent work suggests a new repetitive pulse transcranial magnetic stimulation (rTMS) brain target that might bring relief. Since this proposed target is not well understood, the goal of the study is to use functional magnetic resonance imaging (fMRI) to identify the brain regions and networks that change with rTMS stimulation at this target area in PTSD patients. Ultimately, this would lead to a personalized approach to rTMS treatment of PTSD based on brain imaging that can be used in a future clinical trial. Participants will be asked to complete psychological testing and questionnaires as well as an initial MRI and two separate TMS-fMRI sessions. Total participation time across all visits is estimated to be five to six hours. Research participation will take place at VA Palo Alto as well as at Stanford University.

Conditions

Post Traumatic Stress Disorder; PTSD

Keywords

Transcranial Magnetic Stimulation; TMS; Magnetic Resonance Imaging; MRI; fMRI; TMS-fMRI

Outcome Measures

Primary Outcomes (3)

• Resting-State fMRI Connectivity

  Measure of the connectivity between the left 8Av and DMN nodes.

  During the resting state fMRI (rsfMRI) session

• FMRI BOLD Response

  Measure of the immediate activation (blood-oxygen-level-dependent change) in the brain regions related to PTSD following transcranial magnetic stimulation using interleaved TMS and fMRI.

  During the TMS-fMRI session

• Changes in Connectivity after cTBS

  Measure of the connectivity changes between the left 8Av and DMN nodes from the initial resting state fMRI and a resting state fMRI collected immediately following inhibitory TMS (cTBS).

  During the TMS-fMRI session

Study Arms (1)

TMS-fMRI

EXPERIMENTAL

Participants will undergo simultaneous TMS-fMRI as part of this study. There will be two locations stimulated: one control region and one target region. Participants will be randomized with respect to the order of receiving stimulation at the locations, but all participants will receive stimulation at both locations as part of the study. All participants will be considered as one group but order effects will be evaluated as an explanatory variable.

Device: TMS-fMRI

Interventions

TMS-fMRI DEVICE

Participants will undergo simultaneous TMS and fMRI

Also known as: Simultaneous TMS and fMRI, Transcranial Magnetic Stimulation and Functional Magnetic Resonance Imaging

TMS-fMRI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 55 years of age
• Ability to maintain a Motor Threshold (MT) with single pulse TMS
• Ability to safely and comfortably undergo an MRI and TMS
• Able to read, verbalize, understand, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments.
• PTSD diagnosis according to the DSM 5, as determined by the Clinician administered PTSD scale (CAPS-5) criteria.
• Commitment to maintaining a stable medication regimen between the two fMRI sessions

You may not qualify if:

• Inability to safely and comfortably undergo an MRI. MRI safety will be determined by the center where MRI's are collected.
• Significant dementia as determined by the Montreal Cognitive Assessments (MoCA)
• Being in urgent need of care that would make participation impossible
• Currently taking medications that increase the risk of seizure or influence hemodynamic response
• Presence of any other condition that has the potential to prevent study completion and/or have a confounding effect on the interpretation of results.

Sponsors & Collaborators

• Allyson Rosen: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

VA Palo Alto

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Magnetic Resonance Imaging; Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Magnetic Field Therapy; Therapeutics

Study Officials

• Allyson C Rosen, Ph.D.

  PAVIR/Palo Alto VAHCS/Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Lavacot, BA

CONTACT

6504935000; james.lavacot@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: order of presentation is randomized
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neuropsychologist

Model Details: A mechanistic study using TMS-functional MRI

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 12, 2022
• Study Start: August 2, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)