Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia
Primary Purpose
Tardive Dyskinesia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Tardive Dyskinesia focused on measuring transcranial Direct Current Stimulation, Randomized Controlled Trial, Schizophrenia, Tardive Dyskinesia, Abnormal Involuntary Movements Scale, Tardive Dyskinesia Rating Scale, Cognition
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Suzhou Psychiatric Hospital
- Suzhou
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active tDCS
Sham tDCS
Arm 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).
For sham stimulation, the device was set to turn off after 30 seconds(study model).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Cambridge Neuropsychological Test Automatic Battery
Each patient was given a series of computerized tests from the Cambridge Neuropsychological Test Automated Battery. The language-independent tests and touch screen technology deliver rapid and non-invasive cognitive assessment. Executive and memory function were assessed with the following three tasks:The Pattern Recognition Memory (PRM), Intra/Extradimensional Set Shift (IED), and Spatial Working Memory.
Full Information
NCT ID
NCT03497013
First Posted
April 3, 2018
Last Updated
August 19, 2022
Sponsor
Suzhou Psychiatric Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03497013
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
August 11, 2020 (Actual)
Study Completion Date
August 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suzhou Psychiatric Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tardive Dyskinesia
Keywords
transcranial Direct Current Stimulation, Randomized Controlled Trial, Schizophrenia, Tardive Dyskinesia, Abnormal Involuntary Movements Scale, Tardive Dyskinesia Rating Scale, Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantOutcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS
Arm Type
Experimental
Arm 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).
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
For sham stimulation, the device was set to turn off after 30 seconds(study model).
Intervention Type
Device
Intervention Name(s)
Active tDCS
Intervention 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).
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
For sham stimulation, the device was set to turn off after 30 seconds(study model).
Primary Outcome Measure Information:
Title
Abnormal Involuntary Movements Scale
Description
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 Outcome Measure Information:
Title
Tardive Dyskinesia Rating Scale
Description
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
Title
Safety and Tolerabilit
Description
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.
Title
Scale for the Assessment of Negative Symptoms
Description
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
Title
Positive and Negative symptom scale
Description
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.
Time Frame
Change from baseline PANSS total scores at 5 weeks
Title
Cambridge Neuropsychological Test Automatic Battery
Description
Each patient was given a series of computerized tests from the Cambridge Neuropsychological Test Automated Battery. The language-independent tests and touch screen technology deliver rapid and non-invasive cognitive assessment. Executive and memory function were assessed with the following three tasks:The Pattern Recognition Memory (PRM), Intra/Extradimensional Set Shift (IED), and Spatial Working Memory.
Time Frame
Change from baseline cognitive function at 3 weeks and 5 weeks and 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guangzhong Yin, MD
Organizational Affiliation
Suzhou Guangji Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Suzhou Psychiatric Hospital
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215137
Country
China
Facility Name
Suzhou
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215237
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia
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