Completed
A Causal Neural Network-level Understanding of Depression and Its Treatment Through Concurrent TMS and fMRI
What is being tested
rTMS Treatment
+ Sham rTMS Treatment
Device
Who is being recruted
Behavior+4
+ Mental Disorders
+ Behavioral Symptoms
From 18 to 50 Years
+12 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-Controlled
Interventional
Study Start: September 2012
Summary
Principal SponsorStanford University
Last updated: April 10, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.This study has a single primary outcome measure and other measures are exploratory. Previous versions of this study record incorrectly listed some exploratory outcome measures as secondary.
Principal SponsorStanford University
Last updated: April 10, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
85 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
BehaviorMental DisordersBehavioral SymptomsDepressive DisorderMood DisordersDepressionDepressive Disorder, Major
Criteria
7 inclusion criteria required to participate
Depression assessed through phone screen
Has failed > 1 previous adequate antidepressant medication trials
Men and women, ages 18 to 50
Must comprehend English well to ensure adequate comprehension of the fMRI and TMS instructions, and of clinical scales
Show More Criteria
5 exclusion criteria prevent from participating
Any contraindication to being scanned in the 3T scanners at the Lucas Center or CNI such as having a pacemaker or implanted device that has not been cleared for scanning at the Lucas Center or CNI
Any unstable medical condition, any significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc
Current electroconvulsive therapy (ECT) or prior treatment failure with ECT
Current rTMS treatment or prior treatment failure with rTMS
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalrTMS will be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS will be delivered using neuro-navigation based on participants' own fMRI images. Daily treatment regiments will last 36.5 minutes and rTMS will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS sessions for adverse events and/or side effects.
Group II
ShamrTMS will be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS will be delivered through sham stimulation electrodes. The rTMS coil will be positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments will last 36.5minutes and sham rTMS will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS sham sessions for adverse events and/or side effects.
Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center