Evaluation of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Mood Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001545
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : July 13, 2006
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:
This study is designed to evaluate repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for depression. In rTMS, a rapidly changing magnetic field passes through your scalp and skull and generates a small electrical pulses in your brain. rTMS at lower intensities has helped some people with depression but we do not know what the results will be in your case using higher intensities, or whether you will be randomized to 3 weeks of high frequency (20 cycles er second), low frequency (1 cycle per second), or inactive (sham)rTMS. You will be assigned to receive one of these types of rTMS over the left front art of your brain five times per week for the three weeks. Each rTMS treatment session should take between 20-30 minutes of actual stimulation, but weekly ratings, memory testing, and blood sampling may require several hours per week. We will also ask you to have brain imaging procedures to see if these will predict response to high vs. low frequency rTMS. If you are randomized to the 3 weeks of sham rTMS, you will have the opportunity to receive one of the active stimulation frequencies for an additional 3 weeks. Responders to any phase will be offered an additional month of rTMS prior to study termination and recommendations of alternative treatments.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Mood Disorder Unipolar Depression Device: Magstim Super Rapid Magnetic Stimulator Device: Cadwell MES-10 Phase 2

Detailed Description:
Repetitive transcranial magnetic stimulation (rTMS) is a new technique for activating the brain noninvasively through the scalp and skull. It has proven effective in producing localized effects on brain function and has opened many areas of human brain function to direct investigation. Preliminary data also suggest potential therapeutic applications in neuropsychiatric illness. We plan to further investigate the possible therapeutic use of rTMS in depression under conditions of high frequency (20 Hz), low (1Hz) frequency, and sham and to also examine possible cognitive or endocrine effects. Among the priorities of this protocol will be to further evaluate the risks of the technique.

Study Type : Interventional  (Clinical Trial)
Enrollment : 91 participants
Primary Purpose: Treatment
Official Title: Evaluation of rTMS in the Treatment of Mood Disorders
Study Start Date : May 1996
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

All patients will receive a psychiatric and physical examination by a qualified physician.

Patients will be from 18 to 90 years of age and must give informed consent.

Unipolar patients must be medication free to participate. Patients with bipolar disorder depression may be medication-free or on any combination (including monotherapy) of lithium, carbamazepine, and valproate. Inpatient monitoring will be provided when medically indicated.


Reasons for exclusion will be the presence of cardiac pacemakers, medication pumps, cochlear implants or metal objects in the head or eyes that could be dangerous if heated or moved by the magnetic pulses.

General contraindications to rTMS or a current diagnosis of alcohol or substance abuse.

Subjects having serious medical illnesses or meeting current psychoactive substance dependence will be excluded from entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001545

United States, Maryland
National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Mental Health (NIMH)

Publications: Identifier: NCT00001545     History of Changes
Other Study ID Numbers: 960086
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: July 13, 2006
Last Verified: July 2006

Keywords provided by National Institutes of Health Clinical Center (CC):
Affective Disorders
Repetitive Transcranial Magnetic Stimulation
Bipolar Disorder
Unipolar Disorder
Unipolar Depression

Additional relevant MeSH terms:
Bipolar Disorder
Mood Disorders
Depressive Disorder
Pathologic Processes
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders