Posttraumatic Stress DisorderMAGNETSNCT06449326
Multimodal Image Analysis and Guidance of Neuromodulation for Trauma-Related Symptoms
A study testing Active Intermittent theta burst stimulation in people with Posttraumatic Stress Disorder, run by University of New Mexico at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Active Intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UNM Center for Psychiatric Research
Albuquerque, New Mexico, 87106
Davin Quinn, MD, 505-272-9494, dquinn@salud.unm.edu
Davin Quinn, MD
- Recruiting
New Mexico VA Health Care System
Albuquerque, New Mexico, 87108
Tiana Maple, 505-265-1711 ext. 4935
About this study
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.
Read the 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
- Being tested
- Active Intermittent theta burst stimulation, Sham Intermittent theta burst stimulation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Intermittent theta burst stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active iTBS | Active comparator | Participants in this arm will undergo 50 sessions of active accelerated (10x/day, five days) image-guided iTBS. Receives: 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. Receives: Device: Sham Intermittent theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPS-5
Clinician Administered PTSD Scale-DSM 5 (range 0-80; higher scores = more symptoms)
Measured: Immediate post-treatment visit
Secondary outcomes (7)
PCL-5
PTSD Checklist-DSM 5 (range 0-80; higher scores = more symptoms)
Measured: Immediate post-treatment visit, 1 month, 3 months, 6 months
PHQ-9
Patient Health Questionnaire-9 (range 0-27; higher scores = more symptoms)
Measured: Immediate post-treatment visit, 1 month, 3 months, 6 months
GAD-7
Generalized Anxiety Disorder-7 (range 0-21; higher scores = more symptoms)
Measured: Immediate post-treatment visit, 1 month, 3 months, 6 months
NSI
Neurobehavioral Symptom Inventory (range 0-88; higher scores = more symptoms)
Measured: 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
Measured: Immediate post-treatment visit, 1 month, 3 months, 6 months
WHODAS
World Health Organization Disability Assessment Schedule (range 0-100; higher scores = more disability)
Measured: Immediate post-treatment visit, 1 month, 3 months, 6 months
PGIC
Patient Global Impression of Change (range 0-7; higher scores = more positive change)
Measured: Immediate post-treatment visit, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jun 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, parallel-design, sham-controlled clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- New Mexico VA Healthcare System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449326
- Sponsor's protocol ID
- 23-451
- Acronym
- MAGNETS
- Status last verified
- Jul 2026
- First submitted
- 6 May 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Image Analysis and Guidance of Neuromodulation for Trauma-Related Symptoms
- ClinicalTrials.gov ID
- NCT06449326
- Acronym / sponsor ID
- MAGNETS / 23-451
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- New Mexico VA Healthcare System
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, parallel-design, sham-controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Active iTBS | Active comparator | Device: Active Intermittent theta burst stimulationParticipants in this arm will undergo 50 sessions of active accelerated (10x/day, five days) image-guided iTBS. |
| Sham iTBS | Sham comparator | Device: Sham Intermittent theta burst stimulationParticipants in this arm will undergo 50 sessions of sham accelerated (10x/day, five days) image-guided iTBS. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veterans will be enrolled in this study if they:
Key exclusion criteria (14 listed)
- Veterans will be excluded from participation in this study if there is:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Intermittent theta burst stimulationIntermittent 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. | Device | Active iTBS |
| Sham Intermittent theta burst stimulationIntermittent 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. | Device | Sham iTBS |
Primary outcome
CAPS-5
Time frame: Immediate post-treatment visit
Clinician Administered PTSD Scale-DSM 5 (range 0-80; higher scores = more symptoms)
7 secondary outcomes
PCL-5
Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months
PHQ-9
Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months
GAD-7
Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months
NSI
Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months
DSM-XC (range 0-92; higher scores = more symptoms)
Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months
WHODAS
Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months
PGIC
Time frame: Immediate post-treatment visit, 1 month, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Intermittent theta burst stimulation in people with Posttraumatic Stress Disorder, run by University of New Mexico at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Davin Quinn, MD (505-272-9494, dquinn@salud.unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAPS-5 (time frame: Immediate post-treatment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.