Recruiting

Neuromodulation

Sponsor:

University of New Mexico

Code:

NCT06449326

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Active Intermittent theta burst stimulation

Sham Intermittent theta burst stimulation

Study Details

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

Study ID

NCT06449326

Start date

Jun 1, 2024

Status verified date

Jul, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active iTBS

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

sham comparator: Sham iTBS

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

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.

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.

Primary outcome measure

  • CAPS-5 [ Time Frame: Immediate post-treatment visit ]

Central Contacts and Locations

Central contacts

Locations

UNM Center for Psychiatric Research

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Principal Investigator:

Davin Quinn, MD

New Mexico VA Health Care System

Recruiting

Albuquerque, New Mexico, United States, 87108

Contacts

Tiana Maple

505-265-1711

More Information

Sponsor

University of New Mexico

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of New Mexico on 2026-07-06.