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

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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