Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2020-08-11

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Tardive Dyskinesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

This study is a randomized, double-blind, sham-controlled clinical trial.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). All evaluations were performed at baseline, the end of 3rd weeks, 5th weeks, and 7th weeks by 2 psychiatrists blinded to the treatment assigned. Inter-rater reliability was satisfactory(ka=0.86).

Study Groups

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Active tDCS

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).

Group Type EXPERIMENTAL

Active tDCS

Intervention Type DEVICE

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).

Sham tDCS

For sham stimulation, the device was set to turn off after 30 seconds(study model).

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

For sham stimulation, the device was set to turn off after 30 seconds(study model).

Interventions

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Active tDCS

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).

Intervention Type DEVICE

Sham tDCS

For sham stimulation, the device was set to turn off after 30 seconds(study model).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No