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CompletedNCT03497013Updated Aug 24, 2022

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

An interventional study of Active tDCS and Sham tDCS in Tardive Dyskinesia, sponsored by Suzhou Psychiatric Hospital. Completed at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-24.

Sponsored by Suzhou Psychiatric Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2017, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Tardive Dyskinesia with a site in China — 3 open to participants now, 3 under way, none of them phase 3. Tardive Dyskinesia · China.

Started
2017
the only one that year
No phase
4 of 10
1 open now
Registered
4th of 10
by date
Lead sponsor
1 of 10
Suzhou Psychiatric Hospital

Among the 10 studies in Tardive Dyskinesia with a site in China, this one is the only one that started in 2017, is one of 4 with no phase, and was the 4th registered.

Tardive Dyskinesia

62 studies on the registry are indexed under Tardive Dyskinesia; 9 are open to participants now.

Browse Tardive Dyskinesia studies →

Open to participants now

3 of the 10 studies in Tardive Dyskinesia with a site in China are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 7 Tardive Dyskinesia studies recruiting now, 2 set no upper age limit and 4 stop at 75 or younger; none take children under 18; none take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study 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).

Read the 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.

03

Conditions studied

  • Tardive Dyskinesia

Keywords

  • transcranial Direct Current Stimulation
  • Randomized Controlled Trial
  • Schizophrenia
  • Tardive Dyskinesia
  • Abnormal Involuntary Movements Scale
  • Tardive Dyskinesia Rating Scale
  • Cognition
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • 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).

    Device: Active tDCS

  • Sham comparator
    Sham tDCS

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

    Device: Sham tDCS

Interventions

  • DeviceActive 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).

  • DeviceSham tDCS

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

06

What researchers measure

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.

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

Secondary outcomes

  1. 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.

    Time frame: Change from baseline TDRS total scores at 3 weeks and 5 weeks and 7 weeks

  2. 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.

    Time frame: We assessed the side affects during and after tDCS.

  3. 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.

    Time frame: Change from baseline SANS total scores at 5 weeks

  4. 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.

    Time frame: Change from baseline PANSS total scores at 5 weeks

  5. 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.

    Time frame: Change from baseline cognitive function at 3 weeks and 5 weeks and 7 weeks

07

Study locations

2 sites
  • Suzhou Psychiatric Hospital
    Suzhou, Jiangsu 215137, China
  • Suzhou
    Suzhou, Jiangsu 215237, China
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in Aug 2020, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 3, 2018
First posted
Apr 13, 2018
StartActual
Jul 31, 2017
Primary completionActual
Aug 11, 2020
CompletionActual
Aug 11, 2020
Last update
Aug 24, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03497013
Lead sponsor
Suzhou Psychiatric Hospital
Responsible party
Xiang-Dong Du (Associate Professor, Suzhou Psychiatric Hospital) — Principal investigator
First posted
Apr 13, 2018
Start date
Jul 31, 2017
Primary completion
Aug 11, 2020
Completion
Aug 11, 2020
Last update
Aug 24, 2022

Study contacts

Guangzhong Yin, MD
study chair · Suzhou Guangji Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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