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A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Bipolar Depression (TMS-BD)

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: NCT00699218
Recruitment Status : Completed
First Posted : June 17, 2008
Results First Posted : July 23, 2018
Last Update Posted : July 23, 2018
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
This is a pilot project to study if repetitive Transcranial Magnetic Stimulation (rTMS) will benefit patients with bipolar depression safely. Based on published studies, this study hypothesizes that rTMS on the left dorsal prefrontal lobe will improve symptoms in some patients who have failed at least two medications.

Condition or disease Intervention/treatment Phase
Mood Disorder Bipolar Disorder Major Depression Depression Device: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K. Not Applicable

Detailed Description:
Candidate with bipolar depression will be screened after signing informed consent. Those who meet the selection criteria will be treated with daily rTMS for 3 weeks and be followed-up at 2 weeks. Participants will keep their ongoing medication unless a medication significantly increases the possibility of seizure. They must be on the same dose of antidepressant medication for least 4 weeks without improvement of symptoms before being recruited into the study. Mood and other observed mental status will be measured by standard psychological scales.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment of Bipolar Depression
Study Start Date : May 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: rTMS treatment
Active rTMS treatment. Transcranial magnetic stimulation using a device called MagStim
Device: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.
High frequency repetitive TMS given daily on weekdays for 3 weeks
Other Name: Repetitive Transcranial Magnetic Stimulation (rTMS)

Primary Outcome Measures :
  1. Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 5 weeks ]
    Scored Questionnaire 0-52, A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression. The higher score means more severe depression.

Secondary Outcome Measures :
  1. Inventory of Depressive Symptomatology [ Time Frame: 5 weeks ]
    Self reported depression scale range 0-84. Questionnaire administered at 1,2, and 3 weeks (end of treatment). We also did a 5 week follow-up. The higher scores indicate greater or more severe depression.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • bipolar I or II patients, currently in a depression episode
  • Patient must have failed at least 2 medication
  • Score of 21-item Hamilton Rating Scale for Depression (HAM-D)

Exclusion Criteria:

  • Rapid cycling bipolar or mixed episode of mood disorder by definition of current DSM criteria
  • Substantial risk of suicide during the screening period that requires inpatient care
  • Presence of psychosis
  • Dual diagnosis of other primary, currently clinically significant severe mental disorders
  • History of other significant neurological diseases, such as seizure disorder, stroke, brain tumors, abnormalities in the blood vessels in brain, dementia, Parkinson's disease, Huntington's chorea or multiple sclerosis
  • History of any medical event that may increase the risk of having seizure, such as head trauma with unconsciousness for more than 5 minutes or a family history of seizure
  • Significant medical complications that may deteriorate during the trial or have increased likelihood of danger consequences
  • Patients who are pregnant or intend to become pregnant during the study period
  • Any metallic prosthesis in head, neck or upper body (including cardiac pace maker) that cannot be safely removed during treatment
  • Current Vagus Nerve Stimulation (VNS) treatment or Electroconvulsive Therapy (ECT) treatment, or with history of failed ECT treatment
  • Patient's Motor Threshold for TMS cannot be detected
  • Significant side effects which are intolerable during the screening or any later stage of the trial
  • Started psychotherapy within the previous 8 weeks or foreseeable psychotherapy will be started or changed in 6 weeks

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): NCT00699218

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United States, California
Center for Mind and Brain
Davis, California, United States, 95618
Sponsors and Collaborators
University of California, Davis
National Alliance for Research on Schizophrenia and Depression
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Principal Investigator: Guohua Xia, M.D., Ph.D. Department of Psychiatry and Behavioral Sciences, UC Davis
Additional Information:
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Responsible Party: University of California, Davis Identifier: NCT00699218    
Other Study ID Numbers: 200715749
First Posted: June 17, 2008    Key Record Dates
Results First Posted: July 23, 2018
Last Update Posted: July 23, 2018
Last Verified: October 2017
Keywords provided by University of California, Davis:
repetitive Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Mood Disorders
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Bipolar and Related Disorders