A Study of Repetitive Transcranial Magnetic Stimulation in Bipolar Patients

Not Applicable

Completed

• Conditions: Bipolar Disorder; Relapse; Cognitive Impairment
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham repetitive transcranial magnetic stimulation

• Registration Number: NCT03207048
• Lead Sponsor: Guangzhou Psychiatric Hospital

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.

Study Timeline

• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-02
• Study Start: 2017-07-10
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active rTMS	Repetitive Transcranial Magnetic Stimulation	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).
Sham rTMS	Sham repetitive transcranial magnetic stimulation	Sham repetitive transcranial magnetic stimulation

Primary Outcome Measures

Name	Time	Method
Changes in the MATRICS Consensus Cognitive Battery	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 Outcome Measures

Name	Time	Method
relapses of depressive and/or hypo/mania episode	12 months	The number of patients who have depression and/or hyop/mania episodes over period of 12 months.

Trial Locations

Locations (1)

Guangzhou Brain hospital(Guangzhou Huiai Hospital); 🇨🇳 Guangzhou, Guangdong, China