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

Tardive Dyskinesia Clinical Trial

Official title:

Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive dyskinesia_a Randomized, Double-blind, Sham-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497013
• Other study ID #: SS201752
• Secondary ID: Szzx201509SS2017
• Status: Completed
• Phase: N/A
• Start date: July 31, 2017
• Est. completion date: August 11, 2020

Study information

• Verified date: August 2022
• Source: Suzhou Psychiatric Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 11, 2020
• Est. primary completion date: August 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Schizophrenia
• Tardive Dyskinesia

Intervention

Device:
• 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).
• Sham tDCS
For sham stimulation, the device was set to turn off after 30 seconds(study model).

Locations

Country	Name	City	State
China	Suzhou	Suzhou	Jiangsu
China	Suzhou Psychiatric Hospital	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Psychiatric Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Change from baseline TDRS total scores at 3 weeks and 5 weeks and 7 weeks
Secondary	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.	We assessed the side affects during and after tDCS.
Secondary	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.	Change from baseline SANS total scores at 5 weeks
Secondary	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.	Change from baseline PANSS total scores at 5 weeks
Secondary	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.	Change from baseline cognitive function at 3 weeks and 5 weeks and 7 weeks