- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04663841
Neural Circuit Biomarkers of Transcranial Magnetic Stimulation Study
Mechanistic Circuit Markers of Transcranial Magnetic Stimulation Outcomes in Pharmacoresistant Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although repetitive transcranial magnetic stimulation (TMS) is becoming a gold standard treatment for pharmacoresistant depression, we lack neural target biomarkers for identifying who is most likely to respond to TMS and why. To address this gap in knowledge this observational study evaluates neural targets defined by activation and functional connectivity of the dorsolateral prefrontal cortex-anchored cognitive control circuit, regions of the default mode network and attention circuit, and interactions with the subgenual anterior cingulate.
The study evaluates whether these targets and interactions between them change in a dose-dependent manner, whether changes in these neural targets correspond to changes in cognitive behavioral performance, and whether baseline and early change in neural target and cognitive behavioral performance predict subsequent symptom severity, suicidality, and quality of life outcomes.
This study is designed as a pragmatic, mechanistic observational trial partnering with the National Clinical TMS Program of the Veteran's Health Administration.
All veterans will receive a clinical course of TMS as part of their routine care. Those who agree to enrollment in the observational study will be assessed at 'baseline' prior to commencement of their TMS treatment, 'first week' after initiation of TMS (targeting five sessions) and 'post-treatment' at the completion of TMS (targeting 30 sessions).
Veterans will be assessed using functional magnetic resonance imaging (fMRI), a cognitive behavioral performance battery, and established questionnaires.
To our knowledge, our study will be the first pragmatic, mechanistic observational trial to use fMRI imaging and cognitive-behavioral performance as biomarkers of TMS treatment response in pharmacoresistant MDD.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Leanne Williams, PhD
- Phone Number: 650-723-3579
- Email: leawillliams@stanford.edu
Study Contact Backup
- Name: Laura Hack, MD, PhD
- Phone Number: 650-655-9434
- Email: lhack@stanford.edu
Study Locations
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California
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Stanford, California, United States, 94305
- Recruiting
- Stanford University Department of Psychiatry
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Principal Investigator:
- Leanne M Williams, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Go-NoGo elicited neural circuit function
Time Frame: Baseline
|
Activation and connectivity assessed using functional magnetic resonance imaging during a GoNoGo task
|
Baseline
|
Go-NoGo elicited neural circuit function
Time Frame: Up to 2 weeks
|
Activation and connectivity assessed using functional magnetic resonance imaging during a GoNoGo task
|
Up to 2 weeks
|
Go-NoGo elicited neural circuit function
Time Frame: Up to 8 weeks
|
Activation and connectivity assessed using functional magnetic resonance imaging during a GoNoGo task
|
Up to 8 weeks
|
N-Back elicited neural circuit function
Time Frame: Baseline
|
Activation and connectivity assessed using functional magnetic resonance imaging during an N-Back task
|
Baseline
|
N-Back elicited neural circuit function
Time Frame: Up to 2 weeks
|
Activation and connectivity assessed using functional magnetic resonance imaging during an N-Back task
|
Up to 2 weeks
|
N-Back elicited neural circuit function
Time Frame: Up to 8 weeks
|
Activation and connectivity assessed using functional magnetic resonance imaging during an N-Back task
|
Up to 8 weeks
|
Resting state neural circuit function
Time Frame: Baseline
|
connectivity assessed using functional magnetic resonance imaging during a resting condition
|
Baseline
|
Resting state neural circuit function
Time Frame: Up to 2 weeks
|
connectivity assessed using functional magnetic resonance imaging during a resting condition
|
Up to 2 weeks
|
Resting state neural circuit function
Time Frame: Up to 8 weeks
|
connectivity assessed using functional magnetic resonance imaging during a resting condition
|
Up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symbol Digit Coding Test
Time Frame: Baseline
|
Cognitive-Behavioral Performance accuracy on the Symbol Digit Coding Test
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Baseline
|
Symbol Digit Coding Test
Time Frame: Up to 2 weeks
|
Cognitive-Behavioral Performance accuracy on the Symbol Digit Coding Test
|
Up to 2 weeks
|
Symbol Digit Coding Test
Time Frame: Up to 8 weeks
|
Cognitive-Behavioral Performance accuracy on the Symbol Digit Coding Test
|
Up to 8 weeks
|
Stroop Test
Time Frame: Baseline
|
Cognitive-Behavioral Performance accuracy and reaction time on the Stroop Test
|
Baseline
|
Stroop Test
Time Frame: Up to 2 weeks
|
Cognitive-Behavioral Performance accuracy and reaction time on the Stroop Test
|
Up to 2 weeks
|
Stroop Test
Time Frame: Up to 8 weeks
|
Cognitive-Behavioral Performance accuracy and reaction time on the Stroop Test
|
Up to 8 weeks
|
Shifting Attention Test
Time Frame: Baseline
|
Cognitive-Behavioral Performance accuracy and reaction time on the Shifting Attention Test
|
Baseline
|
Shifting Attention Test
Time Frame: Up to 2 weeks
|
Cognitive-Behavioral Performance accuracy and reaction time on the Shifting Attention Test
|
Up to 2 weeks
|
Shifting Attention Test
Time Frame: Up to 8 weeks
|
Cognitive-Behavioral Performance accuracy and reaction time on the Shifting Attention Test
|
Up to 8 weeks
|
Continuous Performance Test
Time Frame: Baseline
|
Cognitive-Behavioral Performance accuracy and reaction time on the Continuous Performance Test platform
|
Baseline
|
Continuous Performance Test
Time Frame: Up to 2 weeks
|
Cognitive-Behavioral Performance accuracy and reaction time on the Continuous Performance Test platform
|
Up to 2 weeks
|
Continuous Performance Test
Time Frame: Up to 8 weeks
|
Cognitive-Behavioral Performance accuracy and reaction time on the Continuous Performance Test platform
|
Up to 8 weeks
|
Depressive Symptoms
Time Frame: Baseline
|
Clinical outcome assessed using the Quick Inventory of Depressive Symptoms (QIDS)- Self Report Form.
The total score ranges from 0 to 27 with higher scores indicating greater severity.
|
Baseline
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Depressive Symptoms
Time Frame: Up to 2 weeks
|
Clinical outcome assessed using the Quick Inventory of Depressive Symptoms (QIDS)- Self Report Form.
The total score ranges from 0 to 27 with higher scores indicating greater severity.
|
Up to 2 weeks
|
Depressive Symptoms
Time Frame: Up to 8 weeks
|
Clinical outcome assessed using the Quick Inventory of Depressive Symptoms (QIDS)- Self Report Form.
The total score ranges from 0 to 27 with higher scores indicating greater severity.
|
Up to 8 weeks
|
Daily function related to quality of life
Time Frame: Baseline
|
Clinical outcome assessed using the Veterans' RAND 36-item Health Survey (VR-36).
All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
|
Baseline
|
Daily function related to quality of life
Time Frame: Up to 2 weeks
|
Clinical outcome assessed using the Veterans' RAND 36-item Health Survey (VR-36).
All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
|
Up to 2 weeks
|
Daily function related to quality of life
Time Frame: Up to 8 weeks
|
Clinical outcome assessed using the Veterans' RAND 36-item Health Survey (VR-36).
All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
|
Up to 8 weeks
|
Suicidal ideation
Time Frame: Baseline
|
Columbia-Suicide Severity Rating Scale (C-SSRS).
The total score ranges from 2 to 25, with a higher number indicating more intense ideation and greater risk.
|
Baseline
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Suicidal ideation
Time Frame: Up to 2 weeks
|
Columbia-Suicide Severity Rating Scale (C-SSRS).
The total score ranges from 2 to 25, with a higher number indicating more intense ideation and greater risk.
|
Up to 2 weeks
|
Suicidal ideation
Time Frame: Up to 8 weeks
|
Columbia-Suicide Severity Rating Scale (C-SSRS).
The total score ranges from 2 to 25, with a higher number indicating more intense ideation and greater risk.
|
Up to 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leanne Williams, PhD, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 52695
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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