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Completed

NCT Number: NCT03207048

A Study of Repetitive Transcranial Magnetic Stimulation 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.

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Key information

Conditions

Cognitive Impairment Bipolar Disorder Bipolar and Related Disorders Cognition Disorders Cognitive Dysfunction Disease Attributes Mental Disorders Mood Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Relapse

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou Brain hospital(Guangzhou Huiai Hospital)

Guangzhou, Guangdong, 510370, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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 repetitive transcranial magnetic stimulation

Device

Sham Transcranial Magnetic Stimulation

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Guangzhou Psychiatric Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2017
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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