Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Seoul National University Hospital
With
Ybrain Inc.
Assessment:
Depression rating scale: HAM-D(Hamiltion Depresiion Rating Scale), HAM-A(Hamilton Anxiety Rating Scale) Maniac rating scale: YMRS(Young Mania rating scale) CGI-BP(Clinical Global Impression-Bipolar) Q-LES-Q-SF(Quality of Life Enjoyment and Satisfaction Short form) Q-LES-Q-Q(Quality of Life Enjoyment and Satisfaction Questionnaire) qEEG(Quantitative Electroencephalography)
Check compliance with mobile application(MINDD-CONNECT) connections.
Age
19–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Type I or Type II of bipolar disorder meets the current major depression diagnostic criteria in DSM-5
CGI Severity of lightness score ≥ 4 points
Taking mood stabilizers for at least four weeks before the day of screening
You may not be if
A history of clinically significant internal neurological disorders or head injury
mental retardation or cognitive impairment that will affect to make a consent form.
Patients at risk of suicide that may require hospitalization as determined by clinicians
A person who is determined to be excluded for using tDCS medical device for other reason (e.g. metal plate is inserted on head, etc.)
A person who is determined to have problems with scalp deformation, inflammatory response or brain wave and attachment of direct current because of other dermatological problem
A woman who disagree with medically allowed contraception\* until 24 weeks after the application of investigational device among woman subject who is possible to get pregnant
\* Medically allowed contraception: condom, oral contraception for at least 3 month, injection or insert contraception, Intrauterine Device, etc.
pregnant woman or lactating woman
A person who is not suitable for this clinical trial based on principal investigator's determination other than above reasons
Clareo Health | tDCS(Transcranial Direct Current Stimulation) Efficacy in Bipolar Depression : RCT Study
