A Study of Repetitive Transcranial Magnetic Stimulation in Bipolar Patients

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207048
• Other study ID #: Guangzhou Psychiatric Hospital
• Status: Completed
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2020
• Source: Guangzhou Psychiatric Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bipolar Disorder
• Cognitive Dysfunction
• Cognitive Impairment
• Recurrence
• Relapse

Intervention

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 repetitive transcranial magnetic stimulation
Sham Transcranial Magnetic Stimulation

Locations

Country	Name	City	State
China	Guangzhou Brain hospital(Guangzhou Huiai Hospital)	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Psychiatric Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the MATRICS Consensus Cognitive Battery	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	relapses of depressive and/or hypo/mania episode	The number of patients who have depression and/or hyop/mania episodes over period of 12 months.	12 months