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

NCT03497013 | Completed DMC

• 2 other identifiers: SS201752Szzx201509
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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).

Conditions

Tardive Dyskinesia

Keywords

transcranial Direct Current Stimulation; Randomized Controlled Trial; Schizophrenia; Tardive Dyskinesia; Abnormal Involuntary Movements Scale; Tardive Dyskinesia Rating Scale; Cognition

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (5)

• 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.

• Scale for the Assessment of Negative Symptoms

  Change from baseline SANS total scores at 5 weeks

• Positive and Negative symptom scale

  Change from baseline PANSS total scores at 5 weeks

• Cambridge Neuropsychological Test Automatic Battery

  Change from baseline cognitive function at 3 weeks and 5 weeks and 7 weeks

Study Arms (2)

Active tDCS

EXPERIMENTAL

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).

Device: Active tDCS

Sham tDCS

SHAM COMPARATOR

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

Device: Sham tDCS

Interventions

Active tDCS 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).

Active tDCS

Sham tDCS DEVICE

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

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Psychiatric Hospital: lead

Study Sites (2)

Suzhou Psychiatric Hospital

Suzhou, Jiangsu, 215137, China

Location

Suzhou

Suzhou, Jiangsu, 215237, China

Location

Related Publications (1)

• Zhou Y, Xia X, Zhao X, Yang R, Wu Y, Liu J, Lyu X, Li Z, Zhang G, Du X. Efficacy and safety of Transcranial Direct Current Stimulation (tDCS) on cognitive function in chronic schizophrenia with Tardive Dyskinesia (TD): a randomized, double-blind, sham-controlled, clinical trial. BMC Psychiatry. 2023 Aug 24;23(1):623. doi: 10.1186/s12888-023-05112-0.

  PMID: 37620825 DERIVED

MeSH Terms

Conditions

Tardive Dyskinesia; Schizophrenia

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Guangzhong Yin, MD

  Suzhou Guangji Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 13, 2018
• Study Start: July 31, 2017
• Primary Completion: August 11, 2020
• Study Completion: August 11, 2020
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)