NCT05646732 · Allyson Rosen
Targeting the Default Mode Network: A TMS-fMRI Study
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
TMS-fMRI
Participants will undergo simultaneous TMS and fMRI
Primary outcome measures
Resting-State fMRI Connectivity
Time frame: During the resting state fMRI (rsfMRI) session
Measure of the connectivity between the left 8Av and DMN nodes.
FMRI BOLD Response
Time frame: During the TMS-fMRI session
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.
Changes in Connectivity after cTBS
Time frame: During the TMS-fMRI session
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Inability to safely and comfortably undergo an MRI. MRI safety will be determined by the center where MRI's are collected.
- Inability to safely and comfortably undergo TMS. TMS exclusions include any history or condition that puts patients at risk.
- Significant dementia as determined by the Montreal Cognitive Assessments (MoCA)
- Common comorbid disorders of Veterans are allowed, but PTSD must be a primary diagnosis causing significant impairment that could not be accounted for by another diagnosis. Medical or mental health conditions that interact with or confound interpretation of PTSD symptoms and anxiety would be exclusionary.
- 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.
Where
- Palo Alto, California
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 3, 2024 · Source of record for eligibility and locations