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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mood Disorder, Bipolar Disorder, Major Depression, Depression

Intervention / Treatment
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* Device: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS treatment<br>Active rTMS treatment. Transcranial magnetic stimulation using a device called MagStim | Device: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.<br>* High frequency repetitive TMS given daily on weekdays for 3 weeks<br>* Other names: Repetitive Transcranial Magnetic Stimulation (rTMS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar, Depression, TMS, repetitive Transcranial Magnetic Stimulation, treatment, Efficacy, Safety