Recruiting

TMS

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05368987

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Transcranial magnetic stimulation (TMS)

Fear Conditioning and Extinction Paradigm

Study Details

Brief summary:

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 UTHealth Houston. The study will include preliminary screenings, baseline visits, and experimental visits across four days

Conditions

PTSD

Study ID

NCT05368987

Start date

Feb 1, 2022

Status verified date

Apr, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Willing and able to provide informed consent.
  • Inclusion Criteria for PTSD Subjects - Diagnosis of current PTSD
  • Inclusion Criteria: Healthy Controls (HC) - no current psychiatric disorders ("Axis I" disorders)

Exclusion Criteria:

  • Lifetime history of seizure or significant head trauma or other significant neurologic disease (e.g., tic disorder)
  • History of serious/significant psychiatric diagnoses ("Axis I" diagnoses)
  • Current significant suicidal ideation, plan or intent or suicidal behavior in past 6 months based on CSSRS and clinical judgment or Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily
  • Use of neuroleptics within one year prior to study
  • Current substance use
  • Pregnancy (to be ruled out by urine β-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).
  • High risk of adverse emotional or behavioral reaction, and/or an inability to understand study procedures or the informed consent process
  • Additional exclusion criteria for Healthy controls (HC) group: Current psychiatric diagnosis ("Axis I" diagnosis)

Study Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Fear Conditioning and Extinction Paradigm, plus Transcranial Magnetic Stimulation (TMS)

Participants will undergo a 3-day experimental paradigm. On day 1, participants will undergo a resting-state and structural scans in the fMRI scanner. The data from this scan will be used to determine the specific location of the TMS target for each participant. And participants will be aversively conditioned to two cues in the fMRI scanner. Task based and resting-state scans will occur on this day.

On day 2, subjects will undergo extinction training outside of the scanner where one of the conditioned cues will be paired with TMS in a temporally and anatomically specific manner. A resting-state scan will occur before and after inside the scanner.

On day 3, conditioned cues will be presented during the extinction recall phase of the study. This phase will be conducted in the fMRI scanner. Task-based and resting-state scans will occur on this day.

Interventions

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.

Fear Conditioning and Extinction Paradigm

Participants will undergo a 3-day experimental paradigm. On day 1, participants will undergo a resting-state and structural scans in the fMRI scanner. The data from this scan will be used to determine the specific location of the TMS target for each participant. And participants will be aversively conditioned to two cues in the fMRI scanner. Task based and resting-state scans will occur on this day.

On day 2, subjects will undergo extinction training outside of the scanner where one of the conditioned cues will be paired with TMS in a temporally and anatomically specific manner. A resting-state scan will occur before and after inside the scanner.

On day 3, conditioned cues will be presented during the extinction recall phase of the study. This phase will be conducted in the fMRI scanner. Task-based and resting-state scans will occur on this day.

Primary outcome measure

  • Skin Conductance Response (SCR) [ Time Frame: Experimental Day 1 ]
  • Skin Conductance Response (SCR) [ Time Frame: Experimental Day 3 ]
  • Functional MRI (fMRI) blood-oxygen-level-dependent (BOLD) responses [ Time Frame: Experimental Day 1 ]
  • Functional MRI (fMRI) blood-oxygen-level-dependent (BOLD) responses [ Time Frame: Experimental Day 3 ]

Central Contacts and Locations

Central contacts

Mohammed Milad, PhD

713-486-2754Mohammed.R.Milad@uth.tmc.edu

Locations

UTHealth Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

Mohammed R. Milad, MD

Mohammed.R.Milad@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-05-05.