The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression

U

University of Tehran

Status

Completed

Conditions

Bipolar Disorder

Treatments

Device: Transcranial Magnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01932749
143

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

bilateral repetitive transcranial magnetic stimulation
Active Comparator group
Description:
Bilateral protocol: Motor threshold 100% /LDLPFC/10Hz/5 second duration/10 second intertrain/ Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain/
Treatment:
Device: Transcranial Magnetic stimulation
unilateral repetitive transcranial magnetic stimulation
Active Comparator group
Description:
Unilateral protocol: Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain
Treatment:
Device: Transcranial Magnetic stimulation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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