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Neuromodulation

TMS for Post-Traumatic Stress Disorder

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

Summary

This trial will study how different parameters of transcranial magnetic stimulation (TMS) affect fear circuits in people with post-traumatic stress disorder (PTSD). 250 subjects will participate at NYU Langone Health.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Oxygen Levels
Skin Conductance Response (SCR)
Secondary outcome measures
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

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
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial magnetic stimulation (TMS)
2013
Completed Phase 4
~510

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.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,379 Previous Clinical Trials
847,868 Total Patients Enrolled
Mohammed Milad, MDPrincipal InvestigatorNYU Langone Health

Media Library

TMS (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05368987 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Healthy Control group, PTSD group
Post-Traumatic Stress Disorder Clinical Trial 2023: TMS Highlights & Side Effects. Trial Name: NCT05368987 — N/A
TMS (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05368987 — N/A
~118 spots leftby Sep 2026