What side effects are associated with this type of intervention?

Transcranial Magnetic Stimulation (TMS) is a non-invasive treatment for PTSD that has shown promise in modulating neural activity in fear circuits. Common side effects of TMS include mild headaches, scalp discomfort at the stimulation site, tingling, spasms or twitching of facial muscles, and lightheadedness. Serious side effects are rare but can include seizures, particularly in individuals with a history of epilepsy. Other treatments for PTSD, such as cognitive-behavioral therapy (CBT) and medications like SSRIs, have their own side effects, including nausea, insomnia, and increased anxiety for medications, and emotional distress during therapy sessions for CBT.

What prior FDA approvals exist?

The FDA has not specifically approved Transcranial Magnetic Stimulation (TMS) for the treatment of Post-Traumatic Stress Disorder (PTSD). However, TMS is being studied for its potential to modulate neural activity in fear circuits, which could benefit PTSD patients. Currently, the primary FDA-approved treatments for PTSD include selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help manage symptoms but do not directly involve neuromodulation techniques like TMS.

What other types of research exist?

Promising novel alternatives to TMS for PTSD treatment include transcutaneous supraorbital nerve stimulation and remote electrical neuromodulation. Both methods have shown efficacy in reducing pain intensity in migraine patients, which suggests potential for broader neuromodulation applications. Additionally, vagus nerve stimulation has been explored for its neuromodulatory effects, although more research is needed to confirm its benefits for PTSD.

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Neuromodulation

TMS for Post-Traumatic Stress Disorder

Q: What is the mechanism of action of this treatment?

Transcranial Magnetic Stimulation (TMS) is a noninvasive treatment that uses magnetic fields to stimulate specific areas of the brain, particularly those involved in fear and anxiety regulation, such as the prefrontal cortex and amygdala. This modulation of neural activity can help reduce symptoms of PTSD by enhancing fear extinction memory consolidation and improving emotional regulation. Understanding these mechanisms is important for PTSD patients as it highlights how TMS can directly target and potentially rectify the neural dysfunctions underlying their condition, offering a promising therapeutic option.

N/A

Recruiting

Led By Mohammed Milad, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of primary PTSD (as determined by SCID) for PTSD Subjects

18 - 70 years of age

Must not have

Currently taking medications that lower the seizure threshold. These include antipsychotics, high dose theophylline or stimulants such as methylphenidate. Patients taking bupropion must be on a stable dose (last 3 months) and take less than or equal to 300 mg/day

Use of psychotropic medication within 4 weeks prior to study (within 6 weeks for fluoxetine, or other long-lived compounds; within one year for neuroleptics)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up experimental day 3

Awards & highlights

No Placebo-Only Group

Summary

This trial uses TMS, a procedure that stimulates brain cells with magnetic fields, to help PTSD patients who struggle with reducing fear responses. The goal is to see if TMS can change brain activity to better manage fear. TMS has been primarily studied for major depression but is increasingly being explored for PTSD treatment.

Who is the study for?

This trial is for right-handed adults aged 18-70 with primary PTSD, without other major psychiatric disorders or significant neurological issues. Participants must not be on psychotropic medication recently, have no metal implants that affect MRI, and cannot be pregnant. Healthy controls matching in age, gender, education, and ethnicity are also included.

What is being tested?

The study tests how transcranial magnetic stimulation (TMS) affects fear extinction memory consolidation in PTSD patients. It involves preliminary screenings and experimental visits over four days at NYU Langone Health to optimize TMS parameters for the best therapeutic outcomes.

What are the potential side effects?

While the description doesn't list specific side effects of TMS, common ones include headache, scalp discomfort during stimulation, lightheadedness or seizures (rare). The procedure is non-invasive but may cause temporary changes in brain activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PTSD by a professional.

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on stable doses of medications like bupropion (<=300 mg/day) or others that may increase seizure risk.

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I haven't taken any psychiatric drugs recently.

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I have never had a seizure, significant head injury, or serious brain condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ experimental day 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~experimental day 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and experimental day 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood Oxygen Levels

Skin Conductance Response (SCR)

Secondary study objectives

Score on Childhood Trauma Questionnaire (CTQ)

Score on Intolerance of Uncertainty Scale (IUS-12) - Short Form

Score on Patient Health Questionnaire (PHQ-9)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PTSD groupExperimental Treatment1 Intervention

Participants will undergo a 3-day experimental paradigm. Before the experiment, participants will undergo a resting-state fMRI scan to determine the specific anatomical location of the TMS target for that particular individual (day 1). The resting-state scan will be about 10 minutes. Functional MRI scans will occur on days 1, 2, 3, and TMS on day 2. A blood draw will occur on experimental day 1 or, if needed due to scheduling, on any of the other experimental visits.

Group II: Healthy Control groupActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial magnetic stimulation (TMS)

2013

Completed Phase 4

~570

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcranial Magnetic Stimulation (TMS) is a noninvasive treatment that uses magnetic fields to stimulate specific areas of the brain, particularly those involved in fear and anxiety regulation, such as the prefrontal cortex and amygdala. This modulation of neural activity can help reduce symptoms of PTSD by enhancing fear extinction memory consolidation and improving emotional regulation. Understanding these mechanisms is important for PTSD patients as it highlights how TMS can directly target and potentially rectify the neural dysfunctions underlying their condition, offering a promising therapeutic option.

Transdiagnostic Symptom Subtypes to Predict Response to Therapeutic Transcranial Magnetic Stimulation in Major Depressive Disorder and Posttraumatic Stress Disorder.