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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: schizophrenia- tDCS
  • Sham Comparator: schizophrenia- sham
  • Experimental: at risk- tDCS
  • Sham Comparator: at risk- sham
  • Experimental: healthy controls for schizophrenia- tDCS
  • Sham Comparator: healthy controls for schizophrenia- sham
  • Experimental: healthy controls for at risk- tDCS
  • Sham Comparator: healthy controls for at risk- sham

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dr WANG Shumei
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dr WANG Shumei, Assistant Professor – The Hong Kong Polytechnic University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.