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

NCT ID: NCT06449326

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2027-10-01

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.

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active iTBS

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

Group Type: ACTIVE_COMPARATOR

Active Intermittent theta burst stimulation

Intervention Type: 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

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

Group Type: SHAM_COMPARATOR

Sham Intermittent theta burst stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New Mexico VA Healthcare System

FED

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UNM Center for Psychiatric Research

Albuquerque, New Mexico, United States

Site Status: RECRUITING

New Mexico VA Health Care System

Albuquerque, New Mexico, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Davin Quinn, MD

Role: CONTACT

dquinn@salud.unm.edu

505-272-9494

Facility Contacts

Davin Quinn, MD

Role: primary

dquinn@salud.unm.edu

505-272-9494

Tiana Maple

Role: primary

505-265-1711 ext. 4935

Other Identifiers

23-451

Identifier Type: -

Identifier Source: org_study_id