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

Primary Purpose

Mood Disorder, Bipolar Disorder, Major Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Mood Disorder focused on measuring Bipolar, Depression, TMS, repetitive Transcranial Magnetic Stimulation, treatment, Efficacy, Safety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Mind and Brain

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rTMS treatment

Arm Description

Active rTMS treatment. Transcranial magnetic stimulation using a device called MagStim

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression (HAM-D)
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

Inventory of Depressive Symptomatology
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.

Full Information

First Posted
June 4, 2008
Last Updated
October 20, 2017
Sponsor
University of California, Davis
Collaborators
National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT00699218
Brief Title
A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Bipolar Depression
Acronym
TMS-BD
Official Title
A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment of Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorder, Bipolar Disorder, Major Depression, Depression
Keywords
Bipolar, Depression, TMS, repetitive Transcranial Magnetic Stimulation, treatment, Efficacy, Safety

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS treatment
Arm Type
Experimental
Arm Description
Active rTMS treatment. Transcranial magnetic stimulation using a device called MagStim
Intervention Type
Device
Intervention Name(s)
Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.
Other Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
High frequency repetitive TMS given daily on weekdays for 3 weeks
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAM-D)
Description
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.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Inventory of Depressive Symptomatology
Description
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.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohua Xia, M.D., Ph.D.
Organizational Affiliation
Department of Psychiatry and Behavioral Sciences, UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Mind and Brain
City
Davis
State/Province
California
ZIP/Postal Code
95618
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ucdmc.ucdavis.edu/psychiatry/
Description
PI facilitation
URL
http://mindbrain.ucdavis.edu/
Description
Trial Location: Center for Mind and Brain
URL
http://tms-bd.blogspot.com/
Description
Dr. Xia's blog briefly introducing the trial

Learn more about this trial

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

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