TMS for PTSD and High Blood Pressure

Overseen By Margaret Bublitz, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Lifespan

Disqualifiers: Pregnant, Suicidality, Psychosis, Bipolar, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how repetitive transcranial magnetic stimulation (TMS) might assist women with both PTSD and high blood pressure. TMS is a non-invasive treatment that uses magnetic fields to stimulate specific brain areas. The researchers aim to determine if TMS can lower blood pressure while alleviating PTSD symptoms. Suitable participants are women diagnosed with PTSD and high blood pressure who are already receiving consistent psychiatric care. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that TMS is safe for treating PTSD and high blood pressure?

A previous study found repetitive transcranial magnetic stimulation (TMS) to be a safe and well-tolerated treatment. Research shows that TMS is a non-invasive method for addressing PTSD (post-traumatic stress disorder) and other conditions like chronic pain. Studies have shown that people usually adhere to TMS treatment, indicating its safety.

Some mild side effects, such as headaches or slight discomfort at the application site, have been reported, but these typically resolve quickly. Serious side effects are rare. The treatment uses magnetic fields to stimulate specific brain areas without involving surgery or medication, enhancing its safety.

Overall, existing evidence suggests TMS is a promising and safe option for those considering joining a trial for PTSD and high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) is unique because it offers a non-invasive approach to treating PTSD and high blood pressure, unlike standard treatments that often rely on medications or psychotherapy. Researchers are excited about TMS because it directly targets the brain's dorsolateral prefrontal cortex, an area involved in mood regulation and stress response, using magnetic pulses. This method could provide a quicker and potentially more effective relief for patients, avoiding some side effects associated with traditional drug therapies.

What evidence suggests that TMS might be an effective treatment for PTSD and high blood pressure?

Research shows that transcranial magnetic stimulation (TMS), which participants in this trial will receive, can help people with post-traumatic stress disorder (PTSD). Some studies suggest that high-frequency TMS may improve PTSD symptoms more than low-frequency TMS. However, other research indicates that TMS might not be significantly more effective than a placebo (inactive) treatment.

For high blood pressure, TMS might help lower it by calming the part of the nervous system that controls the "fight or flight" response. Early animal studies suggest TMS can reduce blood pressure, but more research in humans is needed to confirm this. Overall, TMS seems promising, but results are mixed, and further studies are necessary. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for English-speaking women aged 18-44 who have PTSD with a PCL-5 score over 33 and diagnosed high blood pressure. They must also show signs of depression (PHQ9 score >5) and be in stable psychiatric treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 30 sessions of active TMS to the left dorsolateral prefrontal cortex over 6 weeks

6 weeks

30 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 24-hour blood pressure monitoring and PTSD symptom assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TMS

Trial Overview The study is examining the effects of repetitive transcranial magnetic stimulation (TMS) on blood pressure in women with PTSD and hypertension, assessing both immediate and long-term outcomes.

How Is the Trial Designed?

Group I: TMS Experimental Treatment 1 Intervention

Participants will receive 30 sessions (5 days/week, 6 consecutive weeks) of active TMS to the left dorsolateral prefrontal cortex (DLPFC). Right DLPFC will be targeted using a modification of the Beam method. TMS will be administered at 10Hz, 120% of motor threshold, 3000 pulses per session

TMS is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in European Union as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in Canada as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

Lifespan

Lead Sponsor

Trials

43

Recruited

41,100+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) has been shown to be effective for treatment-resistant major depressive disorder (trMDD), but there is limited evidence for its use in patients with comorbid posttraumatic stress disorder (PTSD).

In a unique case, a patient with both trMDD and PTSD experienced remission of symptoms after receiving rTMS targeting the left dorsolateral prefrontal cortex, suggesting potential benefits of rTMS in this specific population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report of a 24-year-old man with resolution of treatment-resistant major depressive disorder and comorbid PTSD using rTMS. Nakama, H., Garcia, A., O'Brien, K., et al.[2015]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

In a study of 33 adults with comorbid major depressive disorder and posttraumatic stress disorder, TMS therapy was shown to alter brain connectivity, particularly between the subgenual anterior cingulate cortex and the default mode network, which predicted clinical improvement.

After TMS treatment, reductions in connectivity between specific brain regions were associated with symptom relief, suggesting that these connectivity changes may serve as biomarkers for treatment response in patients with these disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Network Mechanisms of Clinical Response to Transcranial Magnetic Stimulation in Posttraumatic Stress Disorder and Major Depressive Disorder. Philip, NS., Barredo, J., van 't Wout-Frank, M., et al.[2020]

Repetitive transcranial magnetic stimulation (rTMS) is a safe treatment option for depression and shows potential for alleviating symptoms of post-traumatic stress disorder (PTSD), particularly when applied to the right dorsolateral prefrontal cortex.

High-frequency rTMS appears to be more effective than low-frequency rTMS in treating PTSD symptoms, possibly by increasing levels of brain-derived neurotrophic factor, which supports brain health and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation treatment for post-traumatic stress disorder]. Jensen, BS., Ashkanian, M.[2018]

Transcranial Magnetic Stimulation (TMS) shows promise as a treatment for PTSD, particularly with high-frequency stimulation of the left dorsolateral prefrontal cortex, which has been found to be more effective than low-frequency stimulation in improving PTSD symptoms.

TMS is generally safe, with headaches being the most common side effect, while serious side effects like seizures are rare and usually linked to pre-existing conditions; however, more extensive research with larger sample sizes is needed to confirm its efficacy for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder. Edinoff, AN., Hegefeld, TL., Petersen, M., et al.[2022]

Bilateral sequential theta-burst stimulation (bsTBS) was well tolerated in a small study of 8 military veterans with treatment-resistant depression (TRD) and comorbid PTSD, showing promising remission rates of 25% and response rates of 38% for depression scores.

The study suggests that bsTBS may be a viable therapeutic option for patients with TRD and PTSD, indicating the need for larger studies to further evaluate its efficacy compared to other rTMS treatment paradigms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral sequential theta burst stimulation in depressed veterans with service related posttraumatic stress disorder: a feasibility study. Vaithianathan, T., Blair, M., Soares, V., et al.[2022]

In a study of 770 veterans with major depressive disorder (MDD), TMS treatment led to significant reductions in both MDD and PTSD symptoms, with a response rate of 41.4% and remission rate of 20% for MDD after receiving an adequate dose of 30 sessions.

The treatment was found to be safe, with side effects aligning with the known safety profile of TMS, and 65.3% of veterans with comorbid PTSD experienced clinically meaningful symptom reductions, indicating TMS's effectiveness in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prefrontal transcranial magnetic stimulation for depression in US military veterans - A naturalistic cohort study in the veterans health administration. Madore, MR., Kozel, FA., Williams, LM., et al.[2023]

Transcranial magnetic stimulation (TMS) has a very low seizure risk, with only 0.08 seizures reported per 1,000 sessions, and less than 0.02 seizures per 1,000 sessions when guidelines are followed for individuals without known risk factors.

The study found that exceeding safety guidelines increases the risk of seizures, and seizures are more likely to occur during the first few TMS sessions, suggesting that TMS is generally safe when administered properly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. Lerner, AJ., Wassermann, EM., Tamir, DI.[2021]

In a rat model of PTSD, high-frequency repetitive transcranial magnetic stimulation (rTMS) effectively prevented anxiety-like behaviors and impaired sensorimotor gating that typically follow stress exposure.

The study suggests that rTMS could be a promising non-pharmacologic treatment for preventing PTSD symptoms, as it mitigated stress-induced increases in cortisol levels and anxiety-related behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation ameliorates anxiety-like behavior and impaired sensorimotor gating in a rat model of post-traumatic stress disorder. Wang, HN., Bai, YH., Chen, YC., et al.[2022]

In a study of 63 obese individuals undergoing a 5-week rTMS treatment for weight control, the treatment showed a reassuring safety profile with no unexpected adverse events reported up to one year after treatment.

The most common side effects were moderate headaches (40.4%) and local pain/discomfort (19.2%), particularly more frequent in the high-frequency rTMS group, but overall, rTMS was well tolerated in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. Ferrulli, A., Massarini, S., Macrì, C., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39092744/

Repetitive transcranial magnetic stimulation for post- ... Our review suggests that active rTMS probably makes little to no difference to PTSD severity immediately following treatment compared to sham stimulation.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016503272100327X

Transcranial magnetic stimulation as a treatment for ... Transcranial magnetic stimulation (TMS) has shown positive outcomes for people with PTSD, using different treatment protocols. This meta- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02981381

Synchronized Transcranial Magnetic Stimulation for PTSD Preliminary data has shown that sTMS can effectively reduce depressive symptoms in MDD. Additionally, the investigators' preliminary examination of IAF in ...

4. nature.com nature.com/articles/s41398-020-0851-5

Non-invasive brain stimulation for posttraumatic stress ... One review and one meta-analysis indicated promising effects of rTMS on PTSD symptom reductions. However, the results remain preliminary, as ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.701348/full

Transcranial Magnetic Stimulation for Post-traumatic Stress ... In current studies, high-frequency stimulation has been shown to be more effective in PTSD rating scales posttreatment than low-frequency stimulation. The most ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05512143

NCT05512143 | TMS for PTSD and Blood Pressure Repetitive transcranial magnetic stimulation (TMS) is a safe, non-invasive, promising novel approach to treat PTSD and reduce risk for CVD. TMS dramatically ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11443297/

Advances in Repetitive Transcranial Magnetic Stimulation for ... Repetitive Transcranial Magnetic Stimulation (rTMS) is a safe and effective technique for treating PTSD, with advantages such as high compliance, low cost, and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11295260/

Repetitive transcranial magnetic stimulation for post‐traumatic ... We included randomized controlled trials (RCTs) assessing the therapeutic efficacy and safety of repetitive transcranial magnetic stimulation (rTMS) for post‐ ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023061510

Personalized repetitive transcranial magnetic stimulation ... Emerging data suggest that post-traumatic stress disorder (PTSD) arises from disrupted brain default mode network (DMN) activity manifested by dysregulated ...

10. hsrd.research.va.gov hsrd.research.va.gov/publications/management_briefs/default.cfm?ManagementBriefsMenu=eBrief-no180&eBriefTitle=Evidence+Brief%3A+Transcranial+Magnetic+Stimulation+%28TMS%29+for+Chronic+Pain%2C+PTSD%2C+TBI%2C+Opioid+Addiction%2C+and+Sexual+Trauma++

Transcranial Magnetic Stimulation (TMS) for Chronic Pain ... rTMS therapy may reduce symptoms in people with chronic pain, post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), and opiate addiction.