Clinical trial NCT01829165: Brain Imaging of rTMS Treatment for Depression
Official title: A Causal Neural Network-level Understanding of Depression and Its Treatment Through Concurrent TMS and fMRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Depression
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: The Dana Foundation
name: National Institute of Mental Health (NIMH)
First posted: 2013-04-11
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overarching goal of this research program is to elucidate causal and directional neural network- level abnormalities in depression, and how they are modulated by an individually-tailored, circuit-directed intervention. By using concurrent TMS and fMRI, the investigators can overcome a major limitation of neuroimaging - the inability to demonstrate causality. The investigators' findings will serve as a platform for future studies wherein TMS treatment can be directly guided by the investigators' ability to image and causally manipulate specific neural networks.

Aim 1: To examine causal interactions between two major brain networks in depression.

Aim 2: To examine the impact of antidepressant TMS on causal network abnormalities in depression.

Hypothesis 1: Depressed subjects will show blunted responses, compared to healthy controls, in two targeted and interacting networks, using concurrent transcranial magnetic stimulation (TMS) and functional magnetic resonance imaging (fMRI).

Hypothesis 2: Treatment of patients with high-frequency repetitive TMS (rTMS) will result in normalization of baseline network-level deficits, and be predicted by degree of baseline network abnormalities.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men and women, ages 18 to 50
* Depression assessed through phone screen
* Must comprehend English well to ensure adequate comprehension of the fMRI and TMS instructions, and of clinical scales
* Has failed \>1 previous adequate antidepressant medication trials
* Right-handed
* No current or history of neurological disorders
* No seizure disorder or risk of seizures

Exclusion Criteria:

* 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 rTMS treatment or prior treatment failure with rTMS
* Current electroconvulsive therapy (ECT) or prior treatment failure with ECT
* Currently pregnant or breastfeeding

Primary outcomes:
measure: Clinician Administered HAM-D
timeFrame: Baseline; Day 10; Day 20
Secondary outcomes:
Other outcomes:
measure: fMRI/TMS Assessed Neural Network Connectivity
timeFrame: Up to 3 months.
measure: Implicit Emotion Regulation
timeFrame: Up to 3 months
measure: fMRI-assessed Resting Connectivity
timeFrame: Up to 3 months.
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References: