Imaging Biomarkers for TMS Treatment of Depression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active rTMS

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.

Group Type ACTIVE_COMPARATOR

repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.

Sham rTMS

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.

Group Type SHAM_COMPARATOR

repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.

Interventions

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repetitive Transcranial Magnetic Stimulation (rTMS)

20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.

Intervention Type DEVICE

Other Intervention Names

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TMS NeuroStar Sham treatment

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No