A Study of Repetitive Transcranial Magnetic Stimulation in Bipolar Patients

Study Overview
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Brief Summary
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This study will investigate the effect of Repetitive transcranial magnetic stimulation (rTMS) on cognition and long-term clinical outcomes of bipolar patients.

Detailed Description
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Cognitive deficits are core features of bipolar disorder. Preliminary evidence shows that repetitive transcranial magnetic stimulation (rTMS) might have positive effects in enhancing cognition and improving clinical symptoms in patients with depression. This study will investigate the effect of rTMS on cognition and long-term outcomes (12 month) of bipolar patients.

Official Title
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Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Cognitive Function and Prevent Relapses in Bipolar Patients

Conditions
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Cognitive Impairment, Relapse, Bipolar Disorder

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation
* Device: Sham repetitive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bipolar Type I or II subjects diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Age 18-60 years Rating on 24-items Hamilton Depression Rating Scale (HAMD)<18 Rating on the Young Mania Rating Scale (YMRS) < 12 Exclusion Criteria: History of any DSM-IV Axis I diagnosis other than BD Type I or II Implanted medication pump or cardiac pacemaker; Have had prior brain surgery Any metal in the head (except in mouth) Any disease of increased Intracranial pressure Suicide attempt Pharmacotherapy unstable medical conditions in the process of changing and redrawing withdrawing psychoactive medications within the past 4 weeks (except for sleeping medications such as benzodiazepines)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active rTMS<br>10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 15 mins each time, 5 times per week for up to 6 weeks (interrupt for 1-2 weeks after 10 times). | Device: Repetitive Transcranial Magnetic Stimulation<br>* Daily left DLPFC, at 110% motor threshold, with a frequency of 10 Hz. Stimulation will be applied in 3-second trains with a 15-second inter-train interval, for 50 trains per session<br>|
| Sham Comparator: Sham rTMS<br>Sham repetitive transcranial magnetic stimulation | Device: Sham repetitive transcranial magnetic stimulation<br>* Sham Transcranial Magnetic Stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the MATRICS Consensus Cognitive Battery | Changes in neurocognitive and social function (measured by the The MATRICS Consensus Cognitive Battery) after 2 session of rTMS treatments (20 times) | one weeks after the completion of the rTMS treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapses of depressive and/or hypo/mania episode | The number of patients who have depression and/or hyop/mania episodes over period of 12 months. | 12 months |