A Study of Repetitive Transcranial Magnetic Stimulation in Bipolar Patients

April 23, 2020 updated by: Kangguang Lin, Guangzhou Psychiatric Hospital

Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Cognitive Function and Prevent Relapses in Bipolar Patients

This study will investigate the effect of Repetitive transcranial magnetic stimulation (rTMS) on cognition and long-term clinical outcomes of bipolar patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cognitive deficits are core features of bipolar disorder. Preliminary evidence shows that repetitive transcranial magnetic stimulation (rTMS) might have positive effects in enhancing cognition and improving clinical symptoms in patients with depression. This study will investigate the effect of rTMS on cognition and long-term outcomes (12 month) of bipolar patients.

Study Type

Interventional

Enrollment (Actual)

42

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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510370
        • Guangzhou Brain hospital(Guangzhou Huiai Hospital)

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bipolar Type I or II subjects diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
  • Age 18-60 years
  • Rating on 24-items Hamilton Depression Rating Scale (HAMD)<18
  • Rating on the Young Mania Rating Scale (YMRS) < 12

Exclusion Criteria:

  • History of any DSM-IV Axis I diagnosis other than BD Type I or II
  • Implanted medication pump or cardiac pacemaker;
  • Have had prior brain surgery
  • Any metal in the head (except in mouth)
  • Any disease of increased Intracranial pressure
  • Suicide attempt
  • Pharmacotherapy
  • unstable medical conditions
  • in the process of changing and redrawing withdrawing psychoactive medications within the past 4 weeks (except for sleeping medications such as benzodiazepines)

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active rTMS
10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 15 mins each time, 5 times per week for up to 6 weeks (interrupt for 1-2 weeks after 10 times).
Device: Repetitive Transcranial Magnetic Stimulation
Daily left DLPFC, at 110% motor threshold, with a frequency of 10 Hz. Stimulation will be applied in 3-second trains with a 15-second inter-train interval, for 50 trains per session
Sham Comparator: Sham rTMS
Sham repetitive transcranial magnetic stimulation
Device: Sham repetitive transcranial magnetic stimulation
Sham Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the MATRICS Consensus Cognitive Battery
Time Frame: one weeks after the completion of the rTMS treatment)
Changes in neurocognitive and social function (measured by the The MATRICS Consensus Cognitive Battery) after 2 session of rTMS treatments (20 times)
one weeks after the completion of the rTMS treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relapses of depressive and/or hypo/mania episode
Time Frame: 12 months
The number of patients who have depression and/or hyop/mania episodes over period of 12 months.
12 months

Collaborators and Investigators

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

Sponsor

Guangzhou Psychiatric Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 10, 2017

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

June 30, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Guangzhou Psychiatric Hospital

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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