Clinical trial NCT03497013: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tardive Dyskinesia
Keywords: transcranial Direct Current Stimulation
Randomized Controlled Trial
Schizophrenia
Tardive Dyskinesia
Abnormal Involuntary Movements Scale
Tardive Dyskinesia Rating Scale
Cognition
Lead sponsor: Suzhou Psychiatric Hospital
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Abnormal Involuntary Movements Scale
timeFrame: Change from baseline AIMS(items1-7) total scores at 3 weeks and 5 weeks and 7 weeks
Secondary outcomes:
measure: Tardive Dyskinesia Rating Scale
timeFrame: Change from baseline TDRS total scores at 3 weeks and 5 weeks and 7 weeks
measure: Safety and Tolerabilit
timeFrame: We assessed the side affects during and after tDCS.
measure: Scale for the Assessment of Negative Symptoms
timeFrame: Change from baseline SANS total scores at 5 weeks
measure: Positive and Negative symptom scale
timeFrame: Change from baseline PANSS total scores at 5 weeks
measure: Cambridge Neuropsychological Test Automatic Battery
timeFrame: Change from baseline cognitive function at 3 weeks and 5 weeks and 7 weeks
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Suzhou Psychiatric Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou
state: Jiangsu
Study officials:
affiliation: Suzhou Guangji Hospital
name: Guangzhong Yin, MD
role: STUDY_CHAIR
References: