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

Suzhou Psychiatric Hospital64 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tardive Dyskinesia

Interventions

Active tDCSDEVICE

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 tDCSDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (2)

Suzhou Psychiatric Hospital

Suzhou, Jiangsu, China

Suzhou

Suzhou, Jiangsu, China

Outcomes

Primary Outcomes

Abnormal Involuntary Movements Scale

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.

Time frame: Change from baseline AIMS(items1-7) total scores at 3 weeks and 5 weeks and 7 weeks

Secondary Outcomes

Tardive Dyskinesia Rating Scale

The severity of TD symptoms were also measured by the total TDRS score and the orofacial dyskinesia subscale scores, trunk and limb dyskinesia subscale scores. The range for TDRS total score is between 44-264 scores and the orofacial dyskinesia subscale scores are between16-96 scores , the trunk and limb dyskinesia subscale scores are between 24-144 scores.The higher values represent a worse outcome.

Time frame: Change from baseline TDRS total scores at 3 weeks and 5 weeks and 7 weeks

Safety and Tolerabilit

Side effects of tDCS were assessed with an experimenter-administered open-ended questionnaire during the whole experiment. The questionnaire contained rating scales regarding the presence and severity of headache, difficulties in concentrating, acute mood changes, visual perceptual changes and any discomforting sensation like pain, tingling, itching or burning under the electrodes.

Time frame: We assessed the side affects during and after tDCS.

Scale for the Assessment of Negative Symptoms

Negative symptoms were assessed with SANS. The range for SANS total scores is between 0-120 scores and the higher values represent a worse outcome.

Time frame: Change from baseline SANS total scores at 5 weeks

Positive and Negative symptom scale

Psychopathology was measured by the total PANSS score and the positive, negative, and general psychopathology subscale scores. The range for PANSS total score is between 30-210 scores and the positive subscale scores are between 7-49 scores and the negative subscale scores are between 7-49 scores and the general psychopathology total scores are between 16-112 scores.

Data from ClinicalTrials.gov

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