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

Primary Purpose

Bipolar Disorder, Mood Disorder, Unipolar Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Magstim Super Rapid Magnetic Stimulator
Cadwell MES-10
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Affective Disorders, Repetitive Transcranial Magnetic Stimulation, Mania, Bipolar Disorder, Depression, Unipolar Disorder, Unipolar Depression

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Mental Health (NIMH)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
July 12, 2006
Sponsor
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00001545
Brief Title
Evaluation of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Mood Disorders
Official Title
Evaluation of rTMS in the Treatment of Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
May 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Mood Disorder, Unipolar Depression
Keywords
Affective Disorders, Repetitive Transcranial Magnetic Stimulation, Mania, Bipolar Disorder, Depression, Unipolar Disorder, Unipolar Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
91 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Magstim Super Rapid Magnetic Stimulator
Intervention Type
Device
Intervention Name(s)
Cadwell MES-10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Institute of Mental Health (NIMH)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11137053
Citation
Speer AM, Kimbrell TA, Wassermann EM, D Repella J, Willis MW, Herscovitch P, Post RM. Opposite effects of high and low frequency rTMS on regional brain activity in depressed patients. Biol Psychiatry. 2000 Dec 15;48(12):1133-41. doi: 10.1016/s0006-3223(00)01065-9.
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Evaluation of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Mood Disorders

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