Recruiting

TMS

Sponsor:

Allyson Rosen

Code:

NCT05646732

Conditions

Post Traumatic Stress Disorder

PTSD

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

TMS-fMRI

Study Details

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

Study ID

NCT05646732

Start date

Aug 2, 2023

Status verified date

Apr, 2024

Completion date

Jan 31, 2025

Anticipated

Primary completion date

Jan 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: TMS-fMRI

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.

Interventions

TMS-fMRI

Participants will undergo simultaneous TMS and fMRI

Primary outcome measure

  • Resting-State fMRI Connectivity [ Time Frame: During the resting state fMRI (rsfMRI) session ]
  • FMRI BOLD Response [ Time Frame: During the TMS-fMRI session ]
  • Changes in Connectivity after cTBS [ Time Frame: During the TMS-fMRI session ]

Central Contacts and Locations

Central contacts

James Lavacot, BA

6504935000james.lavacot@va.gov

Locations

VA Palo Alto

Recruiting

Palo Alto, California, United States, 94304

Contacts

James Lavacot, BA

650-493-5000James.Lavacot@va.gov

Allyson C Rosen, PhD

650-512-3094

Principal Investigator:

Allyson C Rosen, PhD

More Information

Sponsor

Allyson Rosen

Last update posted

Apr 3, 2024

Last verified

Apr, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Allyson Rosen on 2024-04-03.