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Completed

NCT Number: NCT03497013

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

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).

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suzhou, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Sham tDCS

Device

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

Primary outcomes

  1. Abnormal Involuntary Movements Scale

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

    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 outcomes

  1. Tardive Dyskinesia Rating Scale

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

    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.

  2. Safety and Tolerabilit

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

    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.

  3. Scale for the Assessment of Negative Symptoms

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

    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.

  4. Positive and Negative symptom scale

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

    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.

  5. Cambridge Neuropsychological Test Automatic Battery

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

    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.

Sponsors and collaborators

Lead sponsor

Suzhou Psychiatric Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2018
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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