RECRUITING

Neuromodulation of the Fear Extinction Circuit Using Temporally and Anatomically Specific TMS in Humans

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Neuromodulation of the Fear Extinction Circuit Using Temporally and Anatomically Specific TMS in Humans

Quick Facts

Study Start:2022-02-01

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05368987

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Willing and able to provide informed consent. * Inclusion Criteria for PTSD Subjects - Diagnosis of current PTSD *	* 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)

Inclusion Criteria

Exclusion Criteria

* Willing and able to provide informed consent.
* Inclusion Criteria for PTSD Subjects - Diagnosis of current PTSD
*

* 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)

Contacts and Locations

Study Contact

Mohammed Milad, PhD

CONTACT

339-222-2239

Mohammed.R.Milad@uth.tmc.edu

Isabel Moallem, PhD

CONTACT

B.Isabel.Moallem@uth.tmc.edu

Principal Investigator

Mohammed Milad, PhD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at Houston (UTHealth Houston)

Study Locations (Sites)

UTHealth Houston

Houston, Texas, 77054

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

Mohammed Milad, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at Houston (UTHealth Houston)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2022-02-01

Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

PTSD