Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset

The purposes of this research are to investigate (1) if schizophrenia patients and at-risk individuals present bradykinesia and dyskinesia and (2) if tDCS improves motor performance in schizophrenia patients and at-risk individuals. The first hypothesis is that both schizophrenia patients and at-risk individuals show bradykinesia and dyskinesia, and the motor symptoms are more severe in the former than the latter. The second hypothesis is that tDCS improves motor performance in schizophrenia patients and at-risk cases.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Dyskinesias; Parkinsonism; Psychosis
• Intervention / Treatment: Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • Recruiting
    • Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria for schizophrenia patients:

• a diagnosis of schizophrenia without other psychiatric diseases
• having stable psychotic symptoms
• a score of 22 or above in Hong Kong version Montreal Cognitive Assessment
• having no neurological diseases and no medical conditions that affect motor performance

No Exclusion Criteria.

Inclusion Criteria for at-risk individuals:

• a score of nine or above in the Chinese version of the 16-item Prodromal Questionnaire (CPQ-16)
• a score of 22 or above in Hong Kong version Montreal Cognitive Assessment
• having no diagnosis of psychiatric diseases
• having no neurological diseases and no medical conditions that affect motor performance

No Exclusion Criteria.

Inclusion Criteria for healthy controls:

• a score less than nine in CPQ-16
• a score of 22 or above in Hong Kong version Montreal Cognitive Assessment
• having no diagnosis of psychiatric diseases
• having no neurological diseases and no medical conditions that affect motor performance.

No Exclusion Criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: schizophrenia- tDCS	Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY); Transcranial direct current stimulation (tDCS) is a non-invasive intervention, which applies low-amplitude direct electric currents to the brain through scalp electrodes. The real (2mA) or sham tDCS intervention will be given for a total of eight sessions in four weeks with 20 minutes per session.
Sham Comparator: schizophrenia- sham	Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY); Transcranial direct current stimulation (tDCS) is a non-invasive intervention, which applies low-amplitude direct electric currents to the brain through scalp electrodes. The real (2mA) or sham tDCS intervention will be given for a total of eight sessions in four weeks with 20 minutes per session.
Experimental: at risk- tDCS	Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY); Transcranial direct current stimulation (tDCS) is a non-invasive intervention, which applies low-amplitude direct electric currents to the brain through scalp electrodes. The real (2mA) or sham tDCS intervention will be given for a total of eight sessions in four weeks with 20 minutes per session.
Sham Comparator: at risk- sham	Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY); Transcranial direct current stimulation (tDCS) is a non-invasive intervention, which applies low-amplitude direct electric currents to the brain through scalp electrodes. The real (2mA) or sham tDCS intervention will be given for a total of eight sessions in four weeks with 20 minutes per session.
Experimental: healthy controls for schizophrenia- tDCS	Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY); Transcranial direct current stimulation (tDCS) is a non-invasive intervention, which applies low-amplitude direct electric currents to the brain through scalp electrodes. The real (2mA) or sham tDCS intervention will be given for a total of eight sessions in four weeks with 20 minutes per session.
Sham Comparator: healthy controls for schizophrenia- sham	Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY); Transcranial direct current stimulation (tDCS) is a non-invasive intervention, which applies low-amplitude direct electric currents to the brain through scalp electrodes. The real (2mA) or sham tDCS intervention will be given for a total of eight sessions in four weeks with 20 minutes per session.
Experimental: healthy controls for at risk- tDCS	Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY); Transcranial direct current stimulation (tDCS) is a non-invasive intervention, which applies low-amplitude direct electric currents to the brain through scalp electrodes. The real (2mA) or sham tDCS intervention will be given for a total of eight sessions in four weeks with 20 minutes per session.
Sham Comparator: healthy controls for at risk- sham	Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY); Transcranial direct current stimulation (tDCS) is a non-invasive intervention, which applies low-amplitude direct electric currents to the brain through scalp electrodes. The real (2mA) or sham tDCS intervention will be given for a total of eight sessions in four weeks with 20 minutes per session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)	normalized movement time (representing severity of parkinsonism). Unit: second/mm	Within one week right before the 1st session of tDCS
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)	normalized movement time (representing severity of parkinsonism). Unit: second/mm	Within one week right after the 8th (last) session of tDCS
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)	normalized number of movement units (representing severity of dyskinesia). Unit: units/mm	Within one week right before the 1st session of tDCS
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)	normalized number of movement units (representing severity of dyskinesia). Unit: units/mm	Within one week right after the 8th (last) session of tDCS

Collaborators and Investigators

• Sponsor: Dr WANG Shumei

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 27, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Basal Ganglia Diseases; Movement Disorders; Schizophrenia; Dyskinesias; Parkinsonian Disorders
• Other Study ID Numbers: HSEARS20190518001

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
• product manufactured in and exported from the U.S.: Yes