Brain Imaging of rTMS Treatment for Depression

NCT ID: NCT01829165

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2017-01-20

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.

Conditions

Major Depressive Disorder; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

rTMS Treatment

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.

Group Type: EXPERIMENTAL

rTMS Treatment

Intervention Type: DEVICE

MRI-compatible TMS stimulator

Sham Treatment

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.

Group Type: SHAM_COMPARATOR

Sham rTMS Treatment

Intervention Type: DEVICE

Interventions

rTMS Treatment

MRI-compatible TMS stimulator

Intervention Type: DEVICE

Sham rTMS Treatment

Intervention Type: DEVICE

Other Intervention Names

Magstim Stimulator; Magventure Stimulator

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Dana Foundation

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Amit Etkin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P30MH089888-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21206

Identifier Type: -

Identifier Source: org_study_id