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

NCT06449326 | Recruiting DMC FDA Device

• 1 other identifier: 23-451
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• CAPS-5

  Clinician Administered PTSD Scale-DSM 5 (range 0-80; higher scores = more symptoms)

  Immediate post-treatment visit

Secondary Outcomes (7)

• PCL-5

  Immediate post-treatment visit, 1 month, 3 months, 6 months

• PHQ-9

  Immediate post-treatment visit, 1 month, 3 months, 6 months

• GAD-7

  Immediate post-treatment visit, 1 month, 3 months, 6 months

• NSI

  Immediate post-treatment visit, 1 month, 3 months, 6 months

• DSM-XC (range 0-92; higher scores = more symptoms)

  Immediate post-treatment visit, 1 month, 3 months, 6 months

Other Outcomes (2)

• AIM

  Immediate post-treatment visit

• fMRI Connectivity

  Immediate post-treatment visit

Study Arms (2)

Active iTBS

ACTIVE COMPARATOR

Participants in this arm will undergo 50 sessions of active accelerated (10x/day, five days) image-guided iTBS.

Device: Active Intermittent theta burst stimulation

Sham iTBS

SHAM COMPARATOR

Participants in this arm will undergo 50 sessions of sham accelerated (10x/day, five days) image-guided iTBS.

Device: Sham Intermittent theta burst stimulation

Interventions

Active Intermittent theta burst stimulation DEVICE

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.

Active iTBS

Sham Intermittent theta burst stimulation DEVICE

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 iTBS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans will be enrolled in this study if they:
• are aged 18-80;
• 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;
• are fluent in English (as the neuropsychological testing tools used are only available in English) and
• have been on stable doses of psychotropic medications for the past month.

You may not qualify if:

• Veterans will be excluded from participation in this study if there is:
• a prior history of other neurological disease beyond mild TBI, as determined by VA/DoD criteria for TBI severity;
• 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;
• history of a psychotic disorder, such as schizophrenia or bipolar disorder, so as to reduce risk of psychiatric decompensation;
• active substance/alcohol dependence without ongoing treatment, to reduce confounding effects on diagnosis and brain imaging;
• presence of any implanted electrical device (e.g., pacemaker), to reduce risk of device malfunction from rTMS;
• recent medical hospitalization (within four weeks), to reduce risk of medical decompensation during the study;
• any condition that would prevent the subject from completing the protocol;
• appointment of a legal representative or inability to provide informed consent, to avoid coercion of a vulnerable population;
• any ongoing litigation related to PTSD, TBI, disability determination, or service connection, to prevent interference with legal proceedings;
• any contraindication to MRI;
• pregnant women, so as to prevent complications;
• membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion;
• Cognitively impaired adults who lack capacity to consent.

Sponsors & Collaborators

• University of New Mexico: lead
• New Mexico VA Healthcare System: collaborator

Study Sites (2)

UNM Center for Psychiatric Research

Albuquerque, New Mexico, 87106, United States

RECRUITING

New Mexico VA Health Care System

Albuquerque, New Mexico, 87108, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Davin Quinn, MD

CONTACT

505-272-9494; dquinn@salud.unm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, parallel-design, sham-controlled clinical trial.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: June 10, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-07

Locations

US (2)