Brain Imaging of rTMS Treatment for Depression

NCT01829165 | Completed Results

• 2 other identifiers: 21206P30MH089888-01
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Depression

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (3)

• fMRI/TMS Assessed Neural Network Connectivity

  Up to 3 months.

• Implicit Emotion Regulation

  Up to 3 months

• fMRI-assessed Resting Connectivity

  Up to 3 months.

Study Arms (2)

rTMS Treatment

EXPERIMENTAL

rTMS 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.

Device: rTMS Treatment

Sham Treatment

SHAM COMPARATOR

rTMS 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.

Device: Sham rTMS Treatment

Interventions

rTMS Treatment DEVICE

MRI-compatible TMS stimulator

Also known as: Magstim Stimulator, Magventure Stimulator

rTMS Treatment

Sham rTMS Treatment DEVICE

Sham Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• The Dana Foundation: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Amit Etkin, MD, PhD
• Organization: Stanford University

aetkin@stanford.edu

(650) 725-5736

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: April 11, 2013
• Study Start: September 1, 2012
• Primary Completion: January 20, 2017
• Study Completion: January 20, 2017
• Last Updated: April 10, 2018
• Results First Posted: April 10, 2018

Record last verified: 2018-03

Locations

US (1)