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Clinical Trials/NCT03207048
NCT03207048
Completed
Not Applicable

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

Guangzhou Psychiatric Hospital1 site in 1 country42 target enrollmentJuly 10, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
Guangzhou Psychiatric Hospital
Enrollment
42
Locations
1
Primary Endpoint
Changes in the MATRICS Consensus Cognitive Battery
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 10, 2017
End Date
December 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Guangzhou Psychiatric Hospital
Responsible Party
Principal Investigator
Principal Investigator

Kangguang Lin

Dr.

Guangzhou Psychiatric Hospital

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • relapses of depressive and/or hypo/mania episode(12 months)

Study Sites (1)

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