Brain Imaging of rTMS Treatment for Depression

Depression Clinical Trial

Official title:

A Causal Neural Network-level Understanding of Depression and Its Treatment Through Concurrent TMS and fMRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829165
• Other study ID #: 21206
• Secondary ID: P30MH089888-01
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: March 10, 2018
• Start date: September 2012
• Est. completion date: January 20, 2017

Study information

• Verified date: March 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 20, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• rTMS Treatment
MRI-compatible TMS stimulator
• Sham rTMS Treatment

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH), The Dana Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	fMRI/TMS Assessed Neural Network Connectivity	From pre- to post-treatment, improvement will be based on enhanced functional connectivity.	Up to 3 months.
Other	Implicit Emotion Regulation	Implicit emotion regulation assessed through emotion conflict task performed during functional imaging. Performance based on reaction time and recruitment of emotion regulation regions during the task.	Up to 3 months
Other	fMRI-assessed Resting Connectivity	From pre- to post-treatment of patients with high-frequency repetitive TMS (rTMS) improvement shall be measured by normalization of baseline network-level deficits.	Up to 3 months.
Primary	Clinician Administered HAM-D	The Hamilton Depression Rating Scale (HAM-D) is a 24-item clinician-administered assessment utilized as a way of determining a patient's level of depression before, during, and after treatment. It takes approximately 15-20 minutes to complete the interview and score the results. Subscale scores are 0-2 (10 questions), 0-3 (2 questions), and 0-4 (12 questions). Subscales are totaled for an overall score (range 0 -76). For the overall score and all subscales, lower scores correspond to fewer symptoms, and higher scores correspond more symptoms.	Baseline; Day 10; Day 20

External Links

•   About our lab
•   Study Description