Personalized TMS for Post-Traumatic Stress Disorder

Recruiting at 1 trial location

Overseen By Matthew Sherwood, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wave Neuroscience

Disqualifiers: Uncontrolled conditions, Pregnancy, Metal objects, Others

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

Compensation: Varies

Number of Visits: 16

Duration: 21-28 days

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new form of brain stimulation therapy called EEG-based Personalized Transcranial Magnetic Stimulation (eTMS) to assist individuals with Post-Traumatic Stress Disorder (PTSD). The aim is to determine if this treatment, which uses small magnetic pulses, can reduce PTSD symptoms in veterans and first responders such as firefighters and police officers. Participants will receive either the actual eTMS treatment or a placebo version to compare results. This trial may suit veterans or first responders who have experienced PTSD symptoms for at least six months. As an unphased trial, it offers participants the chance to contribute to pioneering research that could lead to new PTSD treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether 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 this eTMS treatment is safe for PTSD?

Research has shown that EEG-based Personalized Transcranial Magnetic Stimulation (eTMS) is generally safe for people with PTSD. In previous studies, participants tolerated eTMS well, and no major health issues were linked to the treatment. Some studies even suggest that eTMS can safely help reduce PTSD symptoms in military personnel.

In one safety study, 26 participants completed the treatment without serious problems, indicating that the treatment might be safe for most people. However, like any treatment, some individuals might experience mild side effects. Overall, the research so far indicates that eTMS is a promising and safe option for PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment because EEG-based Personalized Transcranial Magnetic Stimulation (eTMS) offers a tailored approach for treating Post-Traumatic Stress Disorder (PTSD). Unlike standard treatments such as cognitive behavioral therapy or medication like SSRIs, eTMS uses brain wave patterns to customize magnetic stimulation, potentially improving effectiveness. This personalized method targets specific brain areas related to PTSD, aiming for faster and more significant relief. Additionally, eTMS is non-invasive, which is a big plus compared to some other interventions.

What evidence suggests that this eTMS treatment is effective for PTSD?

This trial will compare EEG-based Personalized Transcranial Magnetic Stimulation (eTMS) with a sham treatment for Post-Traumatic Stress Disorder (PTSD). Studies have shown that Transcranial Magnetic Stimulation (TMS) can effectively treat PTSD by targeting a brain area involved in mood regulation. By stimulating this area, TMS may help reduce PTSD symptoms. Research indicates that personalized TMS, which uses a brain scan to tailor the treatment, could enhance these effects. Additionally, early findings suggest that TMS helps restore normal brain activity disrupted by PTSD. ^{1 2 4 5 6}

Who Is on the Research Team?

Bill Phillips, PhD

Principal Investigator

Wave Neuroscience, Inc.

Are You a Good Fit for This Trial?

This trial is for U.S. Military veterans or first responders aged 22-65 with PTSD diagnosed by DSM-5 criteria, symptoms lasting at least 6 months, and a certain score on the PCL-5 scale. It's not for those who've had ECT/rTMS, have uncontrolled health conditions, are pregnant without birth control use, have metal in their head, history of seizures or epilepsy (or family history), current involvement in other trials, or high risk of suicide/violence.

Inclusion Criteria

Willing and able to consent to participate in the study via signed Informed Consent

I have been diagnosed with PTSD by a professional.

I am between 22 and 65 years old.

Exclusion Criteria

I have undergone ECT or rTMS therapy.

I have a health condition that is not well-managed.

I am not pregnant and willing to use birth control during the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Approximately 10 months

EEG Recording

EEG recording to determine optimal treatment parameters for the eTMS system

1 day

1 visit (in-person)

Treatment

Participants receive 15 treatment days of EEG-based personalized TMS or sham TMS over a maximum of 28 days

21-28 days

15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EEG-based Personalized Transcranial Magnetic Stimulation (eTMS)

Trial Overview The study tests EEG-based personalized TMS against a sham treatment to manage PTSD symptoms. Participants undergo an initial EEG to tailor the eTMS system settings followed by fifteen sessions over three to four weeks where two treatments are given per office visit.

How Is the Trial Designed?

Group I: Active eTMS treatment Active Control 1 Intervention

15 treatment days of EEG-based personalized TMS over a maximum of 28 days. Two sessions per treatment day. Each session consists of TMS treatment at 80% Motor Threshold, pulse frequency between 8-13 Hz. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day.

Group II: Sham eTMS Treatment Placebo Group 1 Intervention

15 treatment days of sham EEG-based personalized TMS over a maximum of 28 days. Two sessions per treatment day. Each session consists of sham TMS treatment. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day.

Who Is Running the Clinical Trial?

Wave Neuroscience

Lead Sponsor

Trials

14

Recruited

1,000+

Published Research Related to This Trial

Transcranial magnetic stimulation (TMS) is a safe and potentially effective treatment for post-traumatic stress disorder (PTSD) and comorbid major depressive disorder (MDD), but the optimal stimulation techniques are still being researched.

In this study involving TMS treatment over multiple sessions, the individualized alpha frequency (IAF) remained stable and did not predict clinical outcomes, suggesting it may not be a useful marker for guiding TMS therapy in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Testing of Peak Alpha Frequency Stability During Repetitive Transcranial Magnetic Stimulation. Petrosino, NJ., Zandvakili, A., Carpenter, LL., 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]

In a study of 29 individuals with comorbid major depressive disorder (MDD) and posttraumatic stress disorder (PTSD), machine learning analysis of EEG coherence was able to predict clinical outcomes after TMS treatment, with a high area under the curve of 0.83 for MDD and 0.71 for PTSD.

The study demonstrated that EEG coherence could effectively differentiate between pre- and post-TMS treatment states, achieving an accuracy of around 75-78% across different brain wave frequencies, suggesting potential for EEG as a screening tool for TMS candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of machine learning in predicting clinical response to transcranial magnetic stimulation in comorbid posttraumatic stress disorder and major depression: A resting state electroencephalography study. Zandvakili, A., Philip, NS., Jones, SR., et al.[2021]

In a study of 20 drug-naive PTSD patients and 16 healthy controls, PTSD patients exhibited significant impairments in GABA(A)-ergic function, particularly in the right hemisphere, indicating a potential imbalance in neurotransmitter systems related to their symptoms.

The findings suggest that the altered cortical excitability in PTSD patients, characterized by increased glutamatergic activity and decreased GABA(A)-ergic function, could inform new treatment strategies using neuromodulation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dysfunctions of cortical excitability in drug-naïve posttraumatic stress disorder patients. Rossi, S., De Capua, A., Tavanti, M., et al.[2021]

In a study involving 24 PTSD patients, high-frequency repetitive transcranial magnetic stimulation (rTMS) at 10 Hz significantly improved core PTSD symptoms and alleviated anxiety over 10 daily sessions.

The results indicate that rTMS targeting the right dorsolateral prefrontal cortex is more effective than low-frequency or sham stimulation, suggesting its potential as a therapeutic intervention for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of the right dorsolateral prefrontal cortex in posttraumatic stress disorder: a double-blind, placebo-controlled study. Cohen, H., Kaplan, Z., Kotler, M., et al.[2022]

In a study of 20 male combat veterans with treatment-resistant PTSD, repetitive transcranial magnetic stimulation (rTMS) significantly reduced hyperarousal symptoms, suggesting its potential effectiveness for this specific symptom.

However, rTMS did not show significant improvements in overall PTSD symptoms or co-occurring depression and anxiety scores, indicating that while it may help with hyperarousal, further research is needed to understand its broader efficacy in PTSD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is transcranial magnetic stimulation effective in treatment-resistant combat related posttraumatic stress disorder? Oznur, T., Akarsu, S., Celik, C., et al.[2014]

This pilot study involving 8 veterans with PTSD shows that combining repetitive transcranial magnetic stimulation (rTMS) with prolonged exposure (PE) therapy is safe and feasible, with a dropout rate similar to traditional PE therapy.

While the overall improvement in PTSD symptoms was not statistically significant, veterans with comorbid major depression experienced notable benefits from rTMS, suggesting potential for enhanced treatment outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure Therapy and Simultaneous Repetitive Transcranial Magnetic Stimulation: A Controlled Pilot Trial for the Treatment of Posttraumatic Stress Disorder. Fryml, LD., Pelic, CG., Acierno, R., et al.[2020]

In a study involving 30 patients with PTSD, both left and right dorsolateral prefrontal cortex (DLPFC) stimulation using 20 Hz rTMS significantly reduced PTSD symptoms, with right DLPFC stimulation showing a larger effect.

The treatment was safe, with no cognitive worsening observed, and the benefits lasted for at least three months after the treatment, suggesting that rTMS could be an effective long-term intervention for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive brain stimulation with high-frequency and low-intensity repetitive transcranial magnetic stimulation treatment for posttraumatic stress disorder. Boggio, PS., Rocha, M., Oliveira, MO., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06081309

NCT06081309 | EEG Personalized Transcranial Magnetic ... The primary outcome for the Study will be the incidence, severity, relatedness, type, subsequent treatment/intervention required, and resolution status of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9193572/

Transcranial Magnetic Stimulation for Post-traumatic Stress ... Regardless of laterality, TMS application to the DLPFC seems to produce the most effective results in treatment of PTSD. Effectiveness of TMS therapy is ...

3. 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06081309?locStr=United%20States&country=United%20States&distance=50&cond=PTSD&intr=TMS&rank=10&tab=results

Study Results | EEG Personalized Transcranial Magnetic ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

5. ctv.veeva.com ctv.veeva.com/study/eeg-personalized-transcranial-magnetic-stimulation-etms-for-post-traumatic-stress-disorder

EEG Personalized Transcranial Magnetic Stimulation (eTMS ... eTMS-PTSD-001 is an open-label safety pilot study with a recruitment goal of 30 subjects, with 26 completers. The Study is intended to evaluate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11224515/

A retrospective chart review to assess the impact of alpha ... This data provides preliminary support for safe application of α-rTMS for symptom reduction in active-duty special operations military personnel.