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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up experimental day 3
Awards & highlights

Study 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.

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

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,476 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to participants who have attained the age of sixty or above?

"This clinical trial is seeking to enroll patients aged 18 and older, yet younger than 70."

Answered by AI

What are the prerequisites for joining this medical trial?

"This examination is recruiting 250 people aged 18 to 70 with post-traumatic stress disorder, who are right handed, healthy controls and lack a current/past history of Axis I psychiatric disorders. Additionally, they must demonstrate the ability to furnish informed consent whilst balancing for age, gender, education level and self-identified ethnicity."

Answered by AI

What is the purpose of this research experiment?

"The primary efficacy variable assessed over the Experimental Day 3 time frame is Blood Oxygen Levels. Supplementary metrics include the Score on State-Trait Anxiety Inventory (STAI) - Form Y1, Patient Health Questionnaire (PHQ-9), and Childhood Trauma Questionnaire (CTQ). STAI has a total score range of 20 to 80, with "no or low anxiety" classified as 20 to 37 points. PHQ-9's total score ranges from 0 to 27; scores between 5 and 9 indicate mild depression while 15 to 19 point towards moderately severe depression. Finally, CTQ consists of 28 items graded 1 through 5"

Answered by AI

How many individuals have volunteered to take part in this clinical research project?

"Affirmative. According to information found on clinicaltrials.gov, this research project is actively seeking out individuals for participation. The trial was first listed on February 1st 2022 and the latest update occurred on May 5th 2022; 250 patients need to be recruited from one medical centre."

Answered by AI

Is recruitment still ongoing for this clinical experiment?

"Affirmative. According to information found on clinicaltrials.gov, this medical trial commenced its recruitment process on the 1st of February 2022 and has been revised most recently on May 5th. The research is enrolling 250 participants at a single location."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
New York
How old are they?
18 - 65
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I would love to get some relief from PTSD. Even if it’s small.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Neuromodulation of the Fear Extinction Circuit Using Temporally and Anatomically Specific TMS in Humans
2022. "Neuromodulation of the Fear Extinction Circuit Using Temporally and Anatomically Specific TMS in Humans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05368987.
All > Ptsd New York
~132 spots leftby Sep 2026
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