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Recruiting NCT07336251

Transcranial Magnetic Stimulation in Veterans With PTSD

No phase Interventional PTSD - Post Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Magnetic Stimulation.
Who it may be relevant to
Registry conditions: PTSD - Post Traumatic Stress Disorder. Basic parameters: 19 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Transcranial Magnetic Stimulation in Veterans With PTSD: A Pilot Study to Examine Mechanism of Effect

Overview

With this research investigators hope to begin to understand how rTMS can improve posttraumatic stress disorder (PTSD) symptoms. TMS improves PTSD through two interrelated mechanisms: change in brain limbic system function and change in systemic inflammatory activation. Participants who decide to join this study, will receive ten rTMS treatments. All participants will undergo a 40-minute rTMS procedure with a member of the study team 10 times over 2-4 weeks. Participants will undergo fMRI scans of the head in order to help researchers better understand potential effects of rTMS on brain activity. In addition, participants will be asked to give two breath and blood samples to look for signs of general inflammation.

Interventions

  • Device Transcranial Magnetic Stimulation
    10 sessions of low frequency rTMS (1Hz) applied to the right dorsolateral prefrontal cortex.

Primary outcome measures

  • Frequency and intensity of PTSD symptoms as assessed by the CAPS-5 [Time frame: From enrollment to the end of treatment at 3 months]
  • 20 item self-report of PTSD symptoms assessed by PCL-5 [Time frame: From enrollment to the end of treatment at 3 months]
Secondary outcome measures (1)
  • A quick self-reported and self administered inventory of depressive symptoms (QIDS-16-SR) [Time frame: From the baseline to the end of the study at 3 months]

Eligibility criteria

Inclusion criteria

  • Age between 19 and 70
  • Eligible for VA healthcare
  • Moderate to severe PTSD as determined by a total score of at least 25 on the CAPS within 7 days of randomization.
  • Agree to have CAPS audio recorded.
  • Ability to obtain a Motor Threshold using the TMS device during screening.
  • If female with childbearing potential, use of acceptable method of birth control (i.e., use of contraceptives, abstinence).
  • Able to read, understand, and sign the informed consent document.

Exclusion criteria

  • Pregnant or lactating woman.
  • MRI is contraindicated
  • Current use of clozapine (any dose) or bupropion (more than 300mg per day).
  • Cardiac pacemaker or implantable defibrillator.
  • Presence of any metal object in the head, including cochlear implants, but excluding dental work in the mouth.
  • Significant central nervous system disorder (stroke, brain mass, epilepsy).
  • Seizure in past one year.
  • Current psychosis or mania.
  • Significant suicidal ideation.
  • Unstable medical conditions.
  • Current alcohol or substance use disorder (except nicotine) that interferes with the patient's ability to participate.
  • CPT or PE for PTSD in the past 2 months.
  • Changes in Fluoxetine, Paroxetine, Sertraline, or Venlafaxine in the past 2 months.
  • Color blind
  • Currently participating in other research studies.
  • Aneurysm Clip
  • Ocular foreign body (e.g., metal shavings)
  • Any implanted device (pumps, infusion devices, etc.)
  • Shrapnel injuries or metal fragments

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • White River Junction VA Hospital — White River Junction

Identifiers

NCT: NCT07336251 · 1869595

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗