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

4 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment TMS for PTSD and high blood pressure?

Research indicates that repetitive transcranial magnetic stimulation (rTMS) can help reduce symptoms of post-traumatic stress disorder (PTSD) by targeting specific brain areas, and it has been shown to be safe and effective in treating depression, which often occurs alongside PTSD. ^{1 2 3 4 5}

Is Transcranial Magnetic Stimulation (TMS) safe for humans?

TMS is generally considered safe for humans, with the most common side effects being mild headaches and scalp pain, which can be treated with over-the-counter pain relievers. Seizures are a rare side effect, usually occurring in individuals with predisposing factors. Safety guidelines have been established and updated over the years to ensure its safe application. ^{4 6 7 8 9}

How is TMS treatment different from other treatments for PTSD and high blood pressure?

TMS (Transcranial Magnetic Stimulation) is unique because it uses magnetic fields to stimulate nerve cells in the brain, which is different from traditional drug treatments. It is non-invasive and has shown promise in treating PTSD by potentially increasing brain-derived neurotrophic factor, which supports brain health. ^{2 3 10 11 12}

What is the purpose of this trial?

In this randomized clinical trial, we will test the short and longer term effects of repetitive transcranial magnetic stimulation (TMS) on blood pressure among reproductive aged female participants with elevated symptoms of post-traumatic stress disorder and hypertension.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Network Mechanisms of Clinical Response to Transcranial Magnetic Stimulation in Posttraumatic Stress Disorder and Major Depressive Disorder. [2020]

2. United States 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. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation treatment for post-traumatic stress disorder]. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Prefrontal transcranial magnetic stimulation for depression in US military veterans - A naturalistic cohort study in the veterans health administration. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of Comorbid PTSD on Outcome of Repetitive Transcranial Magnetic Stimulation (TMS) for Veterans With Depression. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. [2021]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Bilateral sequential theta burst stimulation in depressed veterans with service related posttraumatic stress disorder: a feasibility study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Clinical Repetitive Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder, Generalized Anxiety Disorder, and Bipolar Disorder. [2019]

12. United States 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. [2015]