Bipolar Disorder
Conditions
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.
Interventions
DEVICETranscranial Magnetic stimulation
Sponsors
University of Tehran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Outpatients male and female with the range of 18-65 years of age 2. The diagnosis of Bipolar disorder according to DSM-IV-TR 3. Completion of consent form 4. Being under supervision of a psychiatrist, 5. Having BDI\>14 6. Being able to adhere to treatment schedule, 7. Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks .
Exclusion criteria
1. The history of rTMS treatment for any reason 2. Intracranial implant and other ferromagnetic materials close to the head 3. Cardiac pacemaker 4. Drug pumps 5. The risk of seizure with any reasons 6. High intracranial pressure 7. The history of epilepsy or seizure in the first relatives 8. Any metal in head 9. Pregnancy 10. Breastfeeding 11. High risk of suicide 12 Having personality disorder in axis II
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depression severity.Depression will be assessed using the Beck depression inventory | Baseline to four weeks | The BDI-II is measured depressive symptoms is administered before treatment, session 10, immediately after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety severity .Anxiety will be assessed using the Beck Anxiety inventory. | Test Day 1, 10 & 20 | The BAI is measured for anxiety and is administered before treatment, session 10, immediately after treatment. |
| Change in World Health Organization Quality of Life- BREF (WHOQOL-BREF) | Test Day 1, 10& 20 | The WHOQOL-BREF is administered for measuring of quality of life before treatment, session 10, immediately after treatment |
| Change in QEEG and low resolution brain electromagnetic tomography (LORETA) | Before treatment, immediately after treatment | QEEG and LORETA is applying for assessment brain waves patterns |
Countries
Iran
Outcome results
None listed