The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effect of repetitive TMS in reduction of depressive symptoms in patients with bipolar disorder. In a randomized, single blind clinical trials, 30 patients with bipolar disorder in Atieh Neuroscience center will be assigned to receive bilateral TMS and unilateral TMS, daily; for 20 sessions. The depressive and anxiety symptoms and quality of life will be assessed before the treatment (pre test) during the treatment (10th session), and after the treatment (post test). QEEG apply before and after rTMS in all subjects.

Official Title
-----------------
The Comparison of Effectiveness of Bilateral rTMS Versus Unilateral TMS in Patients With Bipolar Depression: a Study Randomized and Single Blind

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Device: Transcranial Magnetic stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients male and female with the range of 18-65 years of age The diagnosis of Bipolar disorder according to DSM-IV-TR Completion of consent form Being under supervision of a psychiatrist, Having BDI>14 Being able to adhere to treatment schedule, Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks . Exclusion Criteria: The history of rTMS treatment for any reason Intracranial implant and other ferromagnetic materials close to the head Cardiac pacemaker Drug pumps The risk of seizure with any reasons High intracranial pressure The history of epilepsy or seizure in the first relatives Any metal in head Pregnancy Breastfeeding High risk of suicide 12 Having personality disorder in axis II

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bilateral repetitive transcranial magnetic stimulation<br>Bilateral protocol: Motor threshold 100% /LDLPFC/10Hz/5 second duration/10 second intertrain/ Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain/ | Device: Transcranial Magnetic stimulation<br> <br> * Other names: Magstim rapid 2;|
| Active Comparator: unilateral repetitive transcranial magnetic stimulation<br>Unilateral protocol: Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain | Device: Transcranial Magnetic stimulation<br> <br> * Other names: Magstim rapid 2;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression severity.Depression will be assessed using the Beck depression inventory | The BDI-II is measured depressive symptoms is administered before treatment, session 10, immediately after treatment. | Baseline to four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety severity .Anxiety will be assessed using the Beck Anxiety inventory. | The BAI is measured for anxiety and is administered before treatment, session 10, immediately after treatment. | Test Day 1, 10 & 20 | 
| Change in World Health Organization Quality of Life- BREF (WHOQOL-BREF) | The WHOQOL-BREF is administered for measuring of quality of life before treatment, session 10, immediately after treatment | Test Day 1, 10& 20 | 
| Change in QEEG and low resolution brain electromagnetic tomography (LORETA) | QEEG and LORETA is applying for assessment brain waves patterns | Before treatment, immediately after treatment |