Clinical trial NCT03207048: A Study of Repetitive Transcranial Magnetic Stimulation in Bipolar Patients
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Cognitive Function and Prevent Relapses in Bipolar Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Relapse
Bipolar Disorder
Lead sponsor: Guangzhou Psychiatric Hospital
Sponsor class: OTHER_GOV
First posted: 2017-07-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Changes in the MATRICS Consensus Cognitive Battery
timeFrame: one weeks after the completion of the rTMS treatment)
Secondary outcomes:
measure: relapses of depressive and/or hypo/mania episode
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Brain hospital(Guangzhou Huiai Hospital)
state: Guangdong
Study officials:
affiliation: Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)
name: kangguang Lin, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin DM, McClintock SM, Forster JJ, Lo TY, Loo CK. Cognitive enhancing effects of rTMS administered to the prefrontal cortex in patients with depression: A systematic review and meta-analysis of individual task effects. Depress Anxiety. 2017 Nov;34(11):1029-1039. doi: 10.1002/da.22658. Epub 2017 May 24.
citation: Kedzior KK, Schuchinsky M, Gerkensmeier I, Loo C. Challenges in comparing the acute cognitive outcomes of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) vs. electroconvulsive therapy (ECT) in major depression: A systematic review. J Psychiatr Res. 2017 Aug;91:14-17. doi: 10.1016/j.jpsychires.2017.03.002. Epub 2017 Mar 2.