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Home > Clinical Trials > A Prospective, Double-Blind, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the H-Coil deep Transcranial Magnetic Stimulation (dTMS) in Conjunction with Mood Stabilizers in Subjects with Bipolar Depression
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Clinical Trials

A Prospective, Double-Blind, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the H-Coil deep Transcranial Magnetic Stimulation (dTMS) in Conjunction with Mood Stabilizers in Subjects with Bipolar Depression

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A research study is being conducted at Duke University Medical Center to evaluate whether dTMS is safe and effective in treating bipolar depression in individuals who are currently taking mood stabilizers and previously have been treated unsuccessfully with antidepressant medications.

Deep transcranial magnetic stimulation (dTMS) is a type of repetitive transcranial magnetic stimulation (rTMS) that is capable of stimulating a larger area of the brain than conventional rTMS. The dTMS is delivered with specially designed coil called the H-Coil. This device is for experimental use only and is not FDA approved.

Study Requirements
This research study will involve adults ages 22-68 who have been diagnosed with Bipolar Disorder 1 and 2. In this multi-site study, research participants will be randomly assigned to receive treatment with dTMS or sham (placebo) given to the prefrontal cortex.
Research participants will receive five treatments per week for four weeks, followed by a taper phase consisting of 3 treatments in the fifth week and 1 treatment in the sixth week (total of 24 treatments). However, treatment will be discontinued if the participant shows no significant improvement after five weeks. Participants will return for two follow-up visits.

For more information, contact Lis Bernhardt at 919-681-0603.

For more information, contact Rosa Jou-Zhang at 919-681-6165.


(REF# Pro00034547)
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Updated: Dec. 5, 2012
Published: Dec. 5, 2012
URL: http://www.dukehealth.org/clinicaltrials/20121203120410440