Purpose

This study aims to explore the mechanisms of how transcranial magnetic stimulation (TMS) impacts fear circuits. The overarching objectives are to understand how varying TMS parameters affect targeted brain regions in order to optimize its impact on enhancing fear extinction memory consolidation in a population with known fear extinction deficiencies: post-traumatic stress disorder (PTSD). 250 subjects will take part in this research study across NYU Langone Health. The study will include preliminary screenings, baseline visits, and experimental visits across four days

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 18 - 70 years of age - Right-handed (Edinburgh Inventory - Oldfield 1971) - To be balanced for age, gender, and years of education, as well as self-identified race/ethnicity. - Inclusion Criteria: PTSD Subjects - Diagnosis of primary PTSD (as determined by SCID) - Inclusion Criteria: Healthy Controls (HC) - SCID diagnosis consistent with no current or past history of Axis I psychiatric disorders. - Willing and able to provide informed consent

Exclusion Criteria

  • Current alcohol or substance use disorder (within the past 6 months) - Lifetime history of seizure or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion) or other significant neurologic disease - Lifetime history of psychosis, bipolar disorder, tic disorder, or eating disorder is excluded. Past and current unipolar mood disorders without psychosis and anxiety disorders will be allowed so long as they are not primary and not associated with psychosis. - 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). - Pregnancy (to be ruled out by urine ß-HCG). - Metallic implants or devices contraindicating magnetic resonance imaging. - 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. - Implanted devices in subject's head (shunts, cochlear implants); metal in subject's head (other than dental implants).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PTSD group
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.
  • Device: Transcranial magnetic stimulation (TMS)
    Research subjects will undergo non-invasive TMS, with a frequency of 20Hz and intensity of 120% of their resting motor threshold (rMT) at varying time points and locations.
Active Comparator
Healthy Control group
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
  • Device: Transcranial magnetic stimulation (TMS)
    Research subjects will undergo non-invasive TMS, with a frequency of 20Hz and intensity of 120% of their resting motor threshold (rMT) at varying time points and locations.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Mohammed Milad, MD
646-754-7406
mohammed.milad@nyulangone.org

Detailed Description

The experiments proposed are aimed to understand how timing and location of transcranial magnetic stimulation (TMS) in humans will impact their ability to reduce conditioned fear responses and impact the activation of their brain regions involved in fear regulation. The researchers will use a novel TMS approach to vary timing and location of its delivery so that the researchers can characterize and establish best time and location to obtain optimal impact on fear inhibition, and then test these parameters in PTSD patients and see if such can rescue extinction deficits in PTSD. The anticipated impact is to enhance our understanding of the neural mechanisms of associated with TMS use and explore potential novel approaches for advancing PTSD treatment.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.