Brief Title
Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia
Official Title
Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive dyskinesia_a Randomized, Double-blind, Sham-controlled Trial
Brief Summary
The aim of the study was to evaluate the efficacy, safety, and cognitive function of
transcranial direct current stimulation (tDCS) in chronic schizophrenia patients with tardive
dyskinesia (TD).
Detailed Description
This study is a randomized, double-blind, sham-controlled clinical trial. 60 patients with TD
were randomly allocated to active (n=30) or sham tDCS groups (n=30). All patients received
2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions:
Monday to Friday once daily, every other week to do a group of treatment). Abnormal
Involuntary Movements Scale (AIMS), Tardive Dyskinesia Rating Scale (TDRS), Assessment of
Negative Symptoms(SANS), the Positive and Negative symptom scale(PANSS), and the Cambridge
Neuropsychological Test Automatic Battery (CANTAB) were assessed in patients. All evaluations
were scored at baseline, the end of 3rd weeks, 5th weeks, and 7th weeks. Side effects of tDCS
were assessed with an experimenter-administered open-ended questionnaire during the whole
experiment.
Study Type
Interventional
Primary Outcome
Abnormal Involuntary Movements Scale
Secondary Outcome
Tardive Dyskinesia Rating Scale
Condition
Tardive Dyskinesia
Intervention
Active tDCS
Study Arms / Comparison Groups
Active tDCS
Description: All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
60
Start Date
July 1, 2017
Completion Date
November 2018
Primary Completion Date
September 2018
Eligibility Criteria
Inclusion Criteria:
1. Right-handed;
2. meeting the diagnosis of schizophrania;
3. had been receiving antipsychotic drugs for at least 12 months;
4. at least one AIMS item rated(moderate) or at least two AIMS items rated ≥2(mild);
5. All patients volunteered to participate in this study.
Exclusion Criteria:
1. organic disorder that could cause movement disorders, mental retardation,and a history
of substance dependence(except nicotine);
2. with serious physical illness(e.g.severe cardiovascular diseases);
3. with color blindness/weakness, stuttering, deafness.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Guangzhong Yin, MD, 88615306213598, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03497013
Organization ID
SS201752
Secondary IDs
Szzx201509
Responsible Party
Principal Investigator
Study Sponsor
Suzhou Psychiatric Hospital
Study Sponsor
Guangzhong Yin, MD, Study Chair, Suzhou Guangji Hospital
Verification Date
July 2017