Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive dyskinesia_a Randomized, Double-blind, Sham-controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tardive Dyskinesia
- Sponsor
- Suzhou Psychiatric Hospital
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- Abnormal Involuntary Movements Scale
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Xiang-Dong Du
Associate Professor
Suzhou Psychiatric Hospital
Eligibility Criteria
Inclusion Criteria
- •Right-handed;
- •meeting the diagnosis of schizophrania;
- •had been receiving antipsychotic drugs for at least 12 months;
- •at least one AIMS item rated(moderate) or at least two AIMS items rated ≥2(mild);
- •All patients volunteered to participate in this study.
Exclusion Criteria
- •organic disorder that could cause movement disorders, mental retardation,and a history of substance dependence(except nicotine);
- •with serious physical illness(e.g.severe cardiovascular diseases);
- •with color blindness/weakness, stuttering, deafness.
Outcomes
Primary Outcomes
Abnormal Involuntary Movements Scale
Time Frame: Change from baseline AIMS(items1-7) total scores at 3 weeks and 5 weeks and 7 weeks
The primary outcome measure was the severity of TD symptoms, which was measured by the AIMS total score(the sum of items 1-7).The range for subscale scores(items1-7) is between 0-28 scores and the higher values represent a worse outcome.
Secondary Outcomes
- Positive and Negative symptom scale(Change from baseline PANSS total scores at 5 weeks)
- Scale for the Assessment of Negative Symptoms(Change from baseline SANS total scores at 5 weeks)
- Tardive Dyskinesia Rating Scale(Change from baseline TDRS total scores at 3 weeks and 5 weeks and 7 weeks)
- Safety and Tolerabilit(We assessed the side affects during and after tDCS.)
- Cambridge Neuropsychological Test Automatic Battery(Change from baseline cognitive function at 3 weeks and 5 weeks and 7 weeks)