- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03497013
Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia
August 19, 2022 updated by: Xiang-Dong Du, Suzhou Psychiatric Hospital
Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive dyskinesia_a Randomized, Double-blind, Sham-controlled Trial
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jiangsu
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Suzhou, Jiangsu, China, 215137
- Suzhou Psychiatric Hospital
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Suzhou, Jiangsu, China, 215237
- Suzhou
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
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 Comparator: Sham tDCS
For sham stimulation, the device was set to turn off after 30 seconds(study model).
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For sham stimulation, the device was set to turn off after 30 seconds(study model).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abnormal Involuntary Movements Scale
Time Frame: Change from baseline AIMS(items1-7) total scores at 3 weeks and 5 weeks and 7 weeks
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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.
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Change from baseline AIMS(items1-7) total scores at 3 weeks and 5 weeks and 7 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tardive Dyskinesia Rating Scale
Time Frame: Change from baseline TDRS total scores at 3 weeks and 5 weeks and 7 weeks
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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.
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Change from baseline TDRS total scores at 3 weeks and 5 weeks and 7 weeks
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Safety and Tolerabilit
Time Frame: We assessed the side affects during and after tDCS.
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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.
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We assessed the side affects during and after tDCS.
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Scale for the Assessment of Negative Symptoms
Time Frame: Change from baseline SANS total scores at 5 weeks
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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.
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Change from baseline SANS total scores at 5 weeks
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Positive and Negative symptom scale
Time Frame: Change from baseline PANSS total scores at 5 weeks
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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.
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Change from baseline PANSS total scores at 5 weeks
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Cambridge Neuropsychological Test Automatic Battery
Time Frame: Change from baseline cognitive function at 3 weeks and 5 weeks and 7 weeks
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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.
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Change from baseline cognitive function at 3 weeks and 5 weeks and 7 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Guangzhong Yin, MD, Suzhou Guangji Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2017
Primary Completion (Actual)
August 11, 2020
Study Completion (Actual)
August 11, 2020
Study Registration Dates
First Submitted
April 3, 2018
First Submitted That Met QC Criteria
April 12, 2018
First Posted (Actual)
April 13, 2018
Study Record Updates
Last Update Posted (Actual)
August 24, 2022
Last Update Submitted That Met QC Criteria
August 19, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SS201752 (Other Grant/Funding Number: Scientific and Technological Program of Suzhou)
- Szzx201509 (Other Grant/Funding Number: Suzhou Key Medical Center for Psychiatric Diseases)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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