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

MAGNETS is a prospective, randomized, parallel-design, sham-controlled clinical trial of accelerated, functional magnetic resonance imaging (fMRI)-guided intermittent theta burst stimulation (iTBS) to the right dorsolateral prefrontal cortex (dlPFC) for chronic symptoms of posttraumatic stress disorder (PTSD) in a comorbid Veteran population.

Study Overview

• Status: Recruiting
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Device: Active Intermittent theta burst stimulation; Device: Sham Intermittent theta burst stimulation

Detailed Description

In MAGNETS, sixty-four participants will be recruited from the NMVAHCS PTSD programs, Polytrauma services, and outpatient mental health clinics. At study entry (Visit #1), participants will undergo baseline demographic, behavioral, and cognitive assessment, and fMRI and diffusion tensor imaging (DTI). The data analysis team will then determine the image-based target in the right hemisphere. Participants will be randomized to either the active (n=32) or sham (n=32) group and undergo 50 sessions of iTBS (10x/day, five days). At end of treatment (Visit #2), they will repeat all baseline tests, including fMRI. One-, three- and six-month symptom levels will be obtained through phone visits (Visits #3-5) to establish longevity and stability of benefit. Repeated measures analyses will be performed on behavioral and connectivity variables, with clinical (age, duration, head injury history) and imaging (white matter fiber counts) features as covariates.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Davin Quinn, MD; Phone Number: 505-272-9494; Email: dquinn@salud.unm.edu

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Recruiting
      • New Mexico VA Health Care System
      • Contact: Tiana Maple; Phone Number: 4935 505-265-1711
    • Albuquerque, New Mexico, United States, 87106
      • Recruiting
      • UNM Center for Psychiatric Research
      • Principal Investigator: Davin Quinn, MD
      • Contact: Davin Quinn, MD; Phone Number: 505-272-9494; Email: dquinn@salud.unm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active iTBS; Participants in this arm will undergo 50 sessions of active accelerated (10x/day, five days) image-guided iTBS.	Device: Active Intermittent theta burst stimulation; Intermittent theta burst stimulation (iTBS) is an efficient form of transcranial magnetic stimulation that allows up to 10x more pulses to be delivered in a given timeframe compared to conventional stimulation patterns.
Sham Comparator: Sham iTBS; Participants in this arm will undergo 50 sessions of sham accelerated (10x/day, five days) image-guided iTBS.	Device: Sham Intermittent theta burst stimulation; Intermittent theta burst stimulation (iTBS) is an efficient form of transcranial magnetic stimulation that allows up to 10x more pulses to be delivered in a given timeframe compared to conventional stimulation patterns.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAPS-5	Clinician Administered PTSD Scale-DSM 5 (range 0-80; higher scores = more symptoms)	Immediate post-treatment visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCL-5	PTSD Checklist-DSM 5 (range 0-80; higher scores = more symptoms)	Immediate post-treatment visit, 1 month, 3 months, 6 months
PHQ-9	Patient Health Questionnaire-9 (range 0-27; higher scores = more symptoms)	Immediate post-treatment visit, 1 month, 3 months, 6 months
GAD-7	Generalized Anxiety Disorder-7 (range 0-21; higher scores = more symptoms)	Immediate post-treatment visit, 1 month, 3 months, 6 months
NSI	Neurobehavioral Symptom Inventory (range 0-88; higher scores = more symptoms)	Immediate post-treatment visit, 1 month, 3 months, 6 months
DSM-XC (range 0-92; higher scores = more symptoms)	Diagnostic and Statistical Manual Cross-Cutting Assessment	Immediate post-treatment visit, 1 month, 3 months, 6 months
WHODAS	World Health Organization Disability Assessment Schedule (range 0-100; higher scores = more disability)	Immediate post-treatment visit, 1 month, 3 months, 6 months
PGIC	Patient Global Impression of Change (range 0-7; higher scores = more positive change)	Immediate post-treatment visit, 1 month, 3 months, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
AIM	Acceptability of Intervention Measure, a four-item measure of the acceptability of an intervention. It has five questions, scored on a 5-point Likert scale, from "completely disagree" to "completely agree"	Immediate post-treatment visit
fMRI Connectivity	Connectivity between the dlPFC and vmPFC (range -1.0 to 1.0; higher scores indicate greater degree of positive correlation	Immediate post-treatment visit

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: New Mexico VA Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 23-451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No