Transcranial Magnetic Stimulation in Bipolar Depression

Study Overview
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Brief Summary
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To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic Stimulation (rTMS) to determine if non-responders can become responders if treated on the other side of the hemisphere (rTMS)

Detailed Description
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Patients will be assigned to one of 3 treatment arms for 10 days of treatment with either left high frequency or right high frequency, or sham rTMS. After 10 days of treatment, and no improvement, another 10 days of treatment follows, this time with the coil placed on the other hemisphere. Subjects will be followed for 2 months respectively with unrestricted treatment provided by their regular physician. Mood stabilizers will be continued throughout this trial.

Official Title
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A Randomized, Sham Controlled, Crossover Trial of rTMS for Bipolar Depression

Conditions
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Bipolar Affective Disorder

Intervention / Treatment
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* Device: Transcranial Magnetic Stimulation (TMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bipolar Depression no physical health problems Exclusion Criteria: Metal in head/neck or skull History of Epilepsy Pregnancy Pacemaker

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 1, Phase l, True or Sham<br>this treatment will be True or Sham (placebo) on one side of the head, phase I | Device: Transcranial Magnetic Stimulation (TMS)<br>* Phase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days. Phase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l -<br>* Other names: VAS;|
| Active Comparator: 2, phase ll, Sham or True<br>This treatment will be Sham(placebo)or True on the other side of the head phase II. | Device: Transcranial Magnetic Stimulation (TMS)<br>* Phase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days. Phase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l -<br>* Other names: VAS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare antidepressant efficacy of right, left to sham |  | within 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if QEEG activity correlates with antidepressant response to rTMS |  | within 9 weeks | 
| To determine if non-responders can become responders if treating the opposite hemisphere |  | within 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Magnetic Stimulation, TMS