Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Cognitive Function and Prevent Relapses in Bipolar Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Changes in the MATRICS Consensus Cognitive Battery
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Kangguang Lin
Dr.
Guangzhou Psychiatric Hospital