Bipolar Disorder, Cognitive Impairment, Relapse
Conditions
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.
Interventions
DEVICERepetitive 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
DEVICESham repetitive transcranial magnetic stimulation
Sham Transcranial Magnetic Stimulation
Sponsors
Guangzhou Psychiatric Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed