Using brain imaging to guide treatment for PTSD in veterans

Multimodal Image Analysis and Guidance of Neuromodulation for Trauma-Related Symptoms

This study is testing whether a new brain treatment using imaging to guide stimulation can help veterans with chronic PTSD feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of New Mexico (other)
• Locations: 2 sites (Albuquerque, New Mexico and 1 other locations)
• Trial ID: NCT06449326 on ClinicalTrials.gov

What this trial studies

This clinical trial, known as MAGNETS, investigates the effects of functional magnetic resonance imaging (fMRI)-guided intermittent theta burst stimulation (iTBS) on veterans suffering from chronic posttraumatic stress disorder (PTSD). Sixty-four participants will be recruited and undergo a series of assessments, including fMRI and cognitive evaluations, to identify specific brain targets for treatment. Participants will be randomly assigned to receive either active or sham stimulation over 50 sessions, with follow-up assessments to evaluate symptom changes over time. The study aims to establish the efficacy of this innovative approach in alleviating PTSD symptoms.

Who should consider this trial

Good fit: Ideal candidates are veterans aged 18-80 with a documented diagnosis of PTSD and ongoing symptoms.

Not a fit: Patients with a history of severe neurological disorders or psychotic disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce PTSD symptoms in veterans, improving their quality of life.

How similar studies have performed: While this approach is innovative, similar studies using brain stimulation techniques have shown promising results in treating PTSD.

Eligibility criteria

Inclusion Criteria:

* Veterans will be enrolled in this study if they:

  1. are aged 18-80;
  2. have a documented diagnosis of PTSD with evidence of ongoing symptoms as demonstrated by score of "31" or higher on the PCL-5, a measure of posttraumatic stress symptoms;
  3. are fluent in English (as the neuropsychological testing tools used are only available in English) and
  4. have been on stable doses of psychotropic medications for the past month.

Exclusion Criteria:

* Veterans will be excluded from participation in this study if there is:

  1. a prior history of other neurological disease beyond mild TBI, as determined by VA/DoD criteria for TBI severity;
  2. any history of seizures beyond immediate posttraumatic seizure or childhood febrile seizure, so as to reduce risk of exacerbation of epilepsy or other neurological symptoms;
  3. history of a psychotic disorder, such as schizophrenia or bipolar disorder, so as to reduce risk of psychiatric decompensation;
  4. active substance/alcohol dependence without ongoing treatment, to reduce confounding effects on diagnosis and brain imaging;
  5. presence of any implanted electrical device (e.g., pacemaker), to reduce risk of device malfunction from rTMS;
  6. recent medical hospitalization (within four weeks), to reduce risk of medical decompensation during the study;
  7. any condition that would prevent the subject from completing the protocol;
  8. appointment of a legal representative or inability to provide informed consent, to avoid coercion of a vulnerable population;
  9. any ongoing litigation related to PTSD, TBI, disability determination, or service connection, to prevent interference with legal proceedings;
  10. any contraindication to MRI;
  11. pregnant women, so as to prevent complications;
  12. membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion;
  13. Cognitively impaired adults who lack capacity to consent.

Where this trial is running

Albuquerque, New Mexico and 1 other locations

• UNM Center for Psychiatric Research — Albuquerque, New Mexico, United States (RECRUITING)
• New Mexico VA Health Care System — Albuquerque, New Mexico, United States (RECRUITING)

Study contacts

• Study coordinator: Davin Quinn, MD

Conditions: Posttraumatic Stress Disorder