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Neuromodulation

Brain Stimulation for PTSD (MAGNETS Trial)

N/A
Recruiting
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Veterans aged 18-80 with a documented diagnosis of PTSD and ongoing symptoms (PCL-5 score of 31 or higher)
Be older than 18 years old
Must not have
Appointment of a legal representative or inability to provide informed consent
Cognitively impaired adults who lack capacity to consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate post-treatment visit, 1 month, 3 months, 6 months
Awards & highlights

Summary

This trial is testing a new treatment for chronic symptoms of PTSD in Veterans. The treatment involves using magnets to stimulate a specific part of the brain while the patient undergoes functional magnetic resonance imaging (fMRI

Who is the study for?
This trial is for English-speaking Veterans aged 18-80 with chronic PTSD symptoms, who have been on stable psychotropic medication doses for a month. It excludes pregnant women, those unable to consent, individuals with certain neurological diseases or seizures, psychotic disorders, implanted electrical devices, recent hospitalizations, ongoing litigation related to PTSD or TBI, MRI contraindications and active substance dependence without treatment.
What is being tested?
The MAGNETS study tests whether targeted brain stimulation (iTBS) can help with PTSD symptoms in Veterans. Participants are randomly assigned to receive either real iTBS or a sham (fake) version while their brain activity is monitored using fMRI technology.
What are the potential side effects?
While the document does not specify side effects of iTBS directly, similar treatments may cause discomfort at the stimulation site, headache, lightheadedness or seizures in very rare cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a veteran aged 18-80 with PTSD and ongoing symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a legal representative or cannot give informed consent myself.
Select...
I am unable to make my own medical decisions due to cognitive impairment.
Select...
I have had seizures not related to recent trauma or childhood fever.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate post-treatment visit, 1 month, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate post-treatment visit, 1 month, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CAPS-5
Secondary study objectives
DSM-XC (range 0-92; higher scores = more symptoms)
GAD-7
NSI
+4 more
Other study objectives
AIM
fMRI Connectivity

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active iTBSActive Control1 Intervention
Participants in this arm will undergo 50 sessions of active accelerated (10x/day, five days) image-guided iTBS.
Group II: Sham iTBSPlacebo Group1 Intervention
Participants in this arm will undergo 50 sessions of sham accelerated (10x/day, five days) image-guided iTBS.

Find a Location

Who is running the clinical trial?

University of New MexicoLead Sponsor
383 Previous Clinical Trials
3,523,130 Total Patients Enrolled
New Mexico VA Healthcare SystemFED
7 Previous Clinical Trials
901 Total Patients Enrolled
~43 spots leftby Oct 2027
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