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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001545
First received: November 3, 1999
Last updated: July 12, 2006
Last verified: July 2006
  Purpose

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 Intervention Phase
Bipolar Disorder
Mood Disorder
Unipolar Depression
Device: Magstim Super Rapid Magnetic Stimulator
Device: Cadwell MES-10
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Evaluation of rTMS in the Treatment of Mood Disorders

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 91
Study Start Date: May 1996
Estimated Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA

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.

EXCLUSION CRITERIA

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001545

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

Publications:
ClinicalTrials.gov Identifier: NCT00001545     History of Changes
Other Study ID Numbers: 960086, 96-M-0086
Study First Received: November 3, 1999
Last Updated: July 12, 2006
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Disease
Mood Disorders
Behavioral Symptoms
Mental Disorders
Affective Disorders, Psychotic
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014