Brain Stimulation for PTSD

(MAGNETS Trial)

Recruiting at 1 trial location

Overseen By Davin Quinn, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Must be taking: Psychotropic medications

Disqualifiers: Neurological disease, Seizures, Psychotic disorder, Substance dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 1 week

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help veterans with ongoing PTSD symptoms using brain stimulation, specifically Intermittent Theta Burst Stimulation (iTBS). Participants will receive either active treatment or a sham (fake) version to compare effects. The brain stimulation targets a specific brain area linked to PTSD to determine if it can reduce symptoms. Veterans diagnosed with PTSD and on stable medication for at least a month may be suitable candidates for this study. As an unphased trial, this study offers veterans the chance to contribute to groundbreaking research that could lead to new PTSD treatments.

Will I have to stop taking my current medications?

The trial requires that participants have been on stable doses of psychotropic medications for the past month, so you will not need to stop taking your current medications if they have been stable.

What prior data suggests that this brain stimulation technique is safe for treating PTSD?

Research has shown that intermittent theta burst stimulation (iTBS) is a promising treatment for PTSD and conditions like depression. Studies have found that iTBS can improve PTSD symptoms without causing major side effects.

For instance, some research found that iTBS effectively reduces PTSD symptoms, such as anger, in veterans, suggesting it may be well-tolerated by similar groups. Other studies have compared iTBS to similar treatments for depression and found it to be just as effective, with no major safety concerns.

Overall, while more research is needed, iTBS has demonstrated a good safety record in studies so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intermittent Theta Burst Stimulation (iTBS) for PTSD because it offers a non-invasive brain stimulation technique that might work faster than traditional therapies like medication and talk therapy. Unlike standard treatments that often take weeks to show effects, iTBS has the potential to deliver results in a much shorter timeframe, possibly within days. This method uses magnetic pulses to target specific brain areas involved in PTSD, which could lead to more precise and effective treatment outcomes. Additionally, the sham iTBS serves as a control to better understand the true impact of the active treatment, helping to solidify the evidence for iTBS's efficacy.

What evidence suggests that this trial's treatments could be effective for PTSD?

In this trial, participants will receive either active intermittent theta burst stimulation (iTBS) or sham iTBS. Research has shown that iTBS can effectively improve PTSD symptoms. Studies have found that iTBS works quickly, with many people feeling better soon after starting treatment. Compared to another brain stimulation method, rTMS, iTBS has a similar positive effect on PTSD symptoms but requires less time. Evidence also suggests that iTBS may help reduce anger in veterans with PTSD. Overall, iTBS is considered a promising new treatment for PTSD. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Fluent in English

I am a veteran aged 18-80 with PTSD and ongoing symptoms.

My mental health medication doses have been stable for the last month.

Exclusion Criteria

Any condition that would prevent the subject from completing the protocol

Pregnant women

I have a legal representative or cannot give informed consent myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline demographic, behavioral, and cognitive assessment, and fMRI and DTI imaging

1 week

1 visit (in-person)

Treatment

Participants receive 50 sessions of iTBS (10x/day, five days) to the right dlPFC

1 week

5 visits (in-person)

Immediate Post-Treatment Assessment

Participants repeat all baseline tests, including fMRI, to assess immediate treatment effects

1 week

1 visit (in-person)

Follow-up

Participants are monitored for symptom levels at 1, 3, and 6 months post-treatment through phone visits

6 months

3 visits (phone)

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Theta Burst Stimulation
• Sham Intermittent Theta Burst Stimulation

Trial Overview 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.

How Is the Trial Designed?

Group I: Active iTBS Active Control 1 Intervention

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

Group II: Sham iTBS Placebo Group 1 Intervention

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

Intermittent Theta Burst Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as iTBS for:

• Treatment-resistant depression

Approved in European Union as iTBS for:

• Treatment-resistant depression

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

New Mexico VA Healthcare System

Collaborator

Trials

9

Recruited

1,100+

Published Research Related to This Trial

In a study of 26 patients with bipolar depression, active intermittent theta burst stimulation (iTBS) showed a high response rate of 72% and a remission rate of 42%, indicating its potential efficacy in treating this condition.

No adverse events were reported, demonstrating that iTBS is safe and well-tolerated, but further research with larger sample sizes is needed to confirm its superiority over sham treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twice-daily neuronavigated intermittent theta burst stimulation for bipolar depression: A Randomized Sham-Controlled Pilot Study. Bulteau, S., Beynel, L., Marendaz, C., et al.[2020]

Intermittent theta burst stimulation (iTBS) for PTSD was tested in a randomized controlled trial with 47 participants before treatment and 43 after, showing that EEG can effectively track changes in brain connectivity related to treatment response.

Using machine learning, the study found that EEG data could accurately distinguish between active and sham treatments with 75% accuracy, suggesting that EEG could be a practical tool for personalizing PTSD treatments based on brain activity patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in functional connectivity after theta-burst transcranial magnetic stimulation for post-traumatic stress disorder: a machine-learning study. Zandvakili, A., Swearingen, HR., Philip, NS.[2022]

A study comparing intermittent theta burst stimulation (iTBS) and 5 Hz transcranial magnetic stimulation (TMS) in veterans with PTSD and major depressive disorder (MDD) found that both treatments were safe and effective, but 5 Hz TMS resulted in significantly better symptom improvement.

Veterans receiving 5 Hz TMS showed greater reductions in PTSD and MDD symptoms compared to those receiving iTBS, suggesting that while iTBS is quicker to administer, it may not be as effective for these conditions based on the current data from 20 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder and Major Depression: Comparing Commonly Used Clinical Protocols. Philip, NS., Doherty, RA., Faucher, C., et al.[2022]

In a study involving 36 multiple sclerosis patients, intermittent theta burst stimulation (iTBS) significantly improved manual dexterity, as shown by faster completion times in the nine-hole peg test and increased performance in the Box and Block Test.

However, iTBS did not have a significant impact on hand motor imagery abilities, indicating that while it can enhance physical tasks, it may not affect cognitive aspects of motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Intermittent Theta Burst Stimulation on Manual Dexterity and Motor Imagery in Patients with Multiple Sclerosis: A Quasi-Experimental Controlled Study. Azin, M., Zangiabadi, N., Iranmanesh, F., et al.[2020]

Intermittent theta burst stimulation (iTBS) significantly reduced anger symptoms in veterans with chronic PTSD after just one week of treatment compared to sham stimulation, indicating its potential efficacy in managing anger associated with PTSD.

The reduction in anger was sustained for at least one month after the treatment, suggesting that iTBS may provide lasting benefits for emotional regulation in PTSD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Secondary Analysis on Effects of Theta Burst Transcranial Magnetic Stimulation to Reduce Anger in Veterans With Posttraumatic Stress Disorder. van 't Wout-Frank, M., Shea, MT., Sorensen, DO., et al.[2022]

Intermittent Theta Burst Stimulation (iTBS) was well-tolerated by eight Australian veterans with PTSD, with only mild to moderate side effects reported, such as cranial pain and headaches, which were manageable with analgesics.

Participants showed significant reductions in PTSD and depression symptoms after 20 sessions of iTBS, along with improvements in cognitive functions like working memory and processing speed, suggesting that iTBS could be a promising new treatment for veterans with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Theta Burst Stimulation for Post-traumatic Stress Disorder in Australian Veterans-A Pilot Study. Nursey, J., Sbisa, A., Knight, H., et al.[2021]

In a study involving 46 veterans with PTSD, those who received 4 weeks of active intermittent theta burst stimulation (iTBS) had significantly better long-term outcomes, with a mean relapse time of 296 days compared to 182 days for those who received only 2 weeks of active treatment.

The study suggests that greater exposure to active iTBS is associated with reduced clinical relapse rates and that neuroimaging of brain connectivity may help predict long-term treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year clinical outcomes following theta burst stimulation for post-traumatic stress disorder. Petrosino, NJ., Wout-Frank, MV'., Aiken, E., et al.[2021]

A study involving 50 veterans with PTSD showed that intermittent theta-burst stimulation (iTBS) significantly improved social and occupational functioning after 2 weeks, indicating its potential efficacy as a treatment for PTSD.

One month after treatment, iTBS demonstrated significant reductions in both clinician- and self-rated PTSD symptoms, as well as improvements in depression and functioning, suggesting that iTBS could be a promising new approach for managing PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theta-Burst Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder. Philip, NS., Barredo, J., Aiken, E., et al.[2020]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0165178123004833

Effects of intermittent theta-burst transcranial magnetic ... ITBS, with a shorter treatment duration, can effectively improve the symptoms of PTSD, with no significant difference in effect from that of rTMS.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31230462/

Theta-Burst Transcranial Magnetic Stimulation for ... iTBS appears to be a promising new treatment for PTSD. Most clinical improvements from stimulation occurred early, which suggests a need for ...

3. nature.com nature.com/articles/s41386-019-0584-4

One-year clinical outcomes following theta burst ... - Nature Theta burst transcranial magnetic stimulation (TBS) is a potential new treatment for post-traumatic stress disorder (PTSD).

4. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2019.18101160

Theta-Burst Transcranial Magnetic Stimulation for ... iTBS appears to be a promising new treatment for PTSD. Most clinical improvements from stimulation occurred early, which suggests a need for further ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8453662/

A secondary analysis on effects of theta burst transcranial ... This secondary analysis suggests that iTBS might reduce anger in veterans with PTSD. Future studies focused on more granular level anger outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6824981/

Theta Burst Transcranial Magnetic Stimulation for ... Intermittent theta-burst stimulation (iTBS) is a new, more rapid administration protocol with data supporting efficacy in depression.