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

Sponsor
Dr WANG Shumei (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04086160
Collaborator
(none)
120
1
8
40.3
3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset
Actual Study Start Date :
Aug 22, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) [Within one week right before the 1st session of tDCS]

    normalized movement time (representing severity of parkinsonism). Unit: second/mm

  2. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) [Within one week right after the 8th (last) session of tDCS]

    normalized movement time (representing severity of parkinsonism). Unit: second/mm

  3. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) [Within one week right before the 1st session of tDCS]

    normalized number of movement units (representing severity of dyskinesia). Unit: units/mm

  4. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) [Within one week right after the 8th (last) session of tDCS]

    normalized number of movement units (representing severity of dyskinesia). Unit: units/mm

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hong Kong Polytechnic University Kowloon Hong Kong

Sponsors and Collaborators

  • Dr WANG Shumei

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr WANG Shumei, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT04086160
Other Study ID Numbers:
  • HSEARS20190518001
First Posted:
Sep 11, 2019
Last Update Posted:
Aug 13, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 13, 2021