The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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bilateral repetitive transcranial magnetic stimulation

Bilateral protocol:

Motor threshold 100% /LDLPFC/10Hz/5 second duration/10 second intertrain/ Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain/

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic stimulation

Intervention Type DEVICE

unilateral repetitive transcranial magnetic stimulation

Unilateral protocol:

Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic stimulation

Intervention Type DEVICE

Interventions

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Transcranial Magnetic stimulation

Intervention Type DEVICE

Other Intervention Names

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Magstim rapid 2

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No