Imaging Biomarkers for TMS Treatment of Depression

University of Michigan

Status: Completed

Conditions: Depression

Treatments: Device: repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01900314

HUM00053677

1R21MH098174-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this research is to learn more about how rTMS works to reduce the symptoms of depression. This information can be used to improve the effectiveness of the treatment. The study will use functional magnetic resonance imaging (fMRI) to examine changes in brain function after treatment with rTMS. fMRI is a safe and painless technique that allows investigators to observe the brain "at work." The investigators will use fMRI to see what regions of the brain become active when you perform a concentration task and how that activation is changed after rTMS.

Enrollment: 40 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary diagnosis of major depressive disorder
• Male and female subjects, ages 22-65
• Have failed at least 1 antidepressant medication at adequate dose and duration
• On stable antidepressant medication regimen for at least 4 weeks prior to TMS therapy

Exclusion criteria

• Diagnosed with a psychotic, bipolar, obsessive-compulsive or post-traumatic stress disorder
• Active substance abuse, including alcohol
• Medical and/or neurological condition that could affect your brain function or risk of seizure, including a stroke, epilepsy, or a closed head injury;
• No presence of an implanted device like a pacemaker/neurostimulator or metal in the head or body;
• Pregnant or trying to get pregnant
• Failed to respond to an adequate course of electroconvulsive therapy (ECT)
• Previous treatment with TMS
• Current depressive episode longer than 5 years

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Active rTMS

Active Comparator group

Description:

20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second fMRI will be completed then 5 additional tapering treatments of rTMS over a 2 week period.

Treatment:

Device: repetitive Transcranial Magnetic Stimulation (rTMS)

Sham rTMS

Sham Comparator group

Description:

20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second fMRI scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.

Treatment:

Device: repetitive Transcranial Magnetic Stimulation (rTMS)