ACTIVE_NOT_RECRUITING

Neural Circuit Biomarkers of Transcranial Magnetic Stimulation Study

Conditions

Depression treatment resistant depression

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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 is currently recruiting Veterans only. The objective of this observational study is to test whether neuroimaging biomarkers of repetitive transcranial magnetic stimulation (TMS) can be prospectively replicated in a large ecologically valid sample. We focus on cognitive network connectivity as a predictive biomarker of the clinical effect of TMS, and as a response biomarker of change with TMS. We address this objective through a pragmatic approach in which we recruit patients undergoing routine clinical care and program evaluation in a Veterans Administration multi-site clinical TMS program.

Official Title

Mechanistic Circuit Markers of Transcranial Magnetic Stimulation Outcomes in Pharmacoresistant Depression

Quick Facts

Study Start:2020-11-02

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04663841

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Ages 18 years and older * Meets Diagnostic and Statistical Manual edition 5 (DSM-5) criteria for Major Depressive Disorder (MDD) (as documented by the treating physician) * Meet study criteria for pharmacoresistance in accordance with the Clinical transcranial magnetic stimulation (TMS) Program (i.e. failed at least one antidepressant in the current episode) * Ability to obtain a motor threshold (MT) prior to the start of treatment * Stable medical conditions and ability to maintain stability on current medication regimen for the duration of treatment * Ability to participate in a daily treatment regimen * Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments	* History of seizure disorder * Structural or neurologic abnormalities present or in close proximity to the treatment site * History of brain surgery * Pacemaker or medical infusion device (unless magnetic resonance imaging compatible) * History of traumatic brain injury within 60 days of the start of treatment * Severe or uncontrolled alcohol or substance use disorders * Active withdrawal from alcohol or substances * Implanted device in the head * Metal in the head * Severe impediment to vision, hearing and/or hand movement, likely to interfere with ability to complete the assessments, or unable and/or unlikely to follow the study protocols * Lifetime history of bipolar I disorder * Inability to speak, read or understand English * Plans to move out of the area during the study period * Clinician and/or Investigator discretion for clinical safety or protocol adherence

Inclusion Criteria

Exclusion Criteria

* Ages 18 years and older
* Meets Diagnostic and Statistical Manual edition 5 (DSM-5) criteria for Major Depressive Disorder (MDD) (as documented by the treating physician)
* Meet study criteria for pharmacoresistance in accordance with the Clinical transcranial magnetic stimulation (TMS) Program (i.e. failed at least one antidepressant in the current episode)
* Ability to obtain a motor threshold (MT) prior to the start of treatment
* Stable medical conditions and ability to maintain stability on current medication regimen for the duration of treatment
* Ability to participate in a daily treatment regimen
* Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments

* History of seizure disorder
* Structural or neurologic abnormalities present or in close proximity to the treatment site
* History of brain surgery
* Pacemaker or medical infusion device (unless magnetic resonance imaging compatible)
* History of traumatic brain injury within 60 days of the start of treatment
* Severe or uncontrolled alcohol or substance use disorders
* Active withdrawal from alcohol or substances
* Implanted device in the head
* Metal in the head
* Severe impediment to vision, hearing and/or hand movement, likely to interfere with ability to complete the assessments, or unable and/or unlikely to follow the study protocols
* Lifetime history of bipolar I disorder
* Inability to speak, read or understand English
* Plans to move out of the area during the study period
* Clinician and/or Investigator discretion for clinical safety or protocol adherence

Contacts and Locations

Principal Investigator

Leanne Williams, PhD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford University Department of Psychiatry

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: Stanford University

Leanne Williams, PhD, PRINCIPAL_INVESTIGATOR, Stanford University

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 Date2020-11-02

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2020-11-02

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

treatment resistant depression

Additional Relevant MeSH Terms

Depression