The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression

April 3, 2014 updated by: reza kazemi, University of Tehran

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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/
Device: Transcranial Magnetic stimulation
Other Names:
  • Magstim rapid 2
Active Comparator: unilateral repetitive transcranial magnetic stimulation

Unilateral protocol:

Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain
Device: Transcranial Magnetic stimulation
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
Time Frame: Baseline to four weeks
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.
Time Frame: Test Day 1, 10 & 20
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)
Time Frame: Test Day 1, 10& 20
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)
Time Frame: Before treatment, immediately after treatment
QEEG and LORETA is applying for assessment brain waves patterns
Before treatment, immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tehran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Estimate)

April 7, 2014

Last Update Submitted That Met QC Criteria

April 3, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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