Neural Circuit Biomarkers of Transcranial Magnetic Stimulation Study

NCT04663841 | Active Not Recruiting DMC

• 1 other identifier: 52695
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

treatment resistant depression

Outcome Measures

Primary Outcomes (9)

• Go-NoGo elicited neural circuit function

  Activation and connectivity assessed using functional magnetic resonance imaging during a GoNoGo task

  Baseline

• Go-NoGo elicited neural circuit function

  Activation and connectivity assessed using functional magnetic resonance imaging during a GoNoGo task

  Up to 2 weeks

• Go-NoGo elicited neural circuit function

  Activation and connectivity assessed using functional magnetic resonance imaging during a GoNoGo task

  Up to 8 weeks

• N-Back elicited neural circuit function

  Activation and connectivity assessed using functional magnetic resonance imaging during an N-Back task

  Baseline

• N-Back elicited neural circuit function

  Activation and connectivity assessed using functional magnetic resonance imaging during an N-Back task

  Up to 2 weeks

• N-Back elicited neural circuit function

  Activation and connectivity assessed using functional magnetic resonance imaging during an N-Back task

  Up to 8 weeks

• Resting state neural circuit function

  connectivity assessed using functional magnetic resonance imaging during a resting condition

  Baseline

• Resting state neural circuit function

  connectivity assessed using functional magnetic resonance imaging during a resting condition

  Up to 2 weeks

• Resting state neural circuit function

  connectivity assessed using functional magnetic resonance imaging during a resting condition

  Up to 8 weeks

Secondary Outcomes (21)

• Symbol Digit Coding Test

  Baseline

• Symbol Digit Coding Test

  Up to 2 weeks

• Symbol Digit Coding Test

  Up to 8 weeks

• Stroop Test

  Baseline

• Stroop Test

  Up to 2 weeks

Interventions

transcranial magnetic stimulation OTHER

transcranial magnetic stimulation is delivered as part of routine care and is not managed by this observational study

Also known as: TMS; repetitive transcranial magnetic stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans with pharmacoresistant major depressive disorder (MDD) participating in the VA Clinical TMS Program. Given the complex nature of the veteran sample, the primary diagnosis of MDD may be comorbid with other disorders, including post-traumatic stress disorder (PTSD).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• VA Palo Alto Health Care System: collaborator
• Florida State University: collaborator
• University of South Florida: collaborator
• Medical University of South Carolina: collaborator
• University of Minnesota: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator
• Brown University: collaborator
• Providence VA Medical Center: collaborator
• Dartmouth College: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• White River Junction VA Medical Center: collaborator

Study Sites (1)

Stanford University Department of Psychiatry

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Treatment-Resistant

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Leanne Williams, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 11, 2020
• Study Start: November 2, 2020
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)