Back to resultsEffects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset
Primary Purpose
Schizophrenia, Psychosis, Parkinsonism
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Transcranial direct current stimulation device (Soterix Medical, New York, NY)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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.
Sites / Locations
- Hong Kong Polytechnic UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Sham Comparator
Experimental
Sham Comparator
Experimental
Sham Comparator
Experimental
Sham Comparator
Arm Label
schizophrenia- tDCS
schizophrenia- sham
at risk- tDCS
at risk- sham
healthy controls for schizophrenia- tDCS
healthy controls for schizophrenia- sham
healthy controls for at risk- tDCS
healthy controls for at risk- sham
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04086160
Brief Title
Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset
Official Title
Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr WANG Shumei
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychosis, Parkinsonism, Dyskinesias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
schizophrenia- tDCS
Arm Type
Experimental
Arm Title
schizophrenia- sham
Arm Type
Sham Comparator
Arm Title
at risk- tDCS
Arm Type
Experimental
Arm Title
at risk- sham
Arm Type
Sham Comparator
Arm Title
healthy controls for schizophrenia- tDCS
Arm Type
Experimental
Arm Title
healthy controls for schizophrenia- sham
Arm Type
Sham Comparator
Arm Title
healthy controls for at risk- tDCS
Arm Type
Experimental
Arm Title
healthy controls for at risk- sham
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation device (Soterix Medical, New York, NY)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Description
normalized movement time (representing severity of parkinsonism). Unit: second/mm
Time Frame
Within one week right before the 1st session of tDCS
Title
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Description
normalized movement time (representing severity of parkinsonism). Unit: second/mm
Time Frame
Within one week right after the 8th (last) session of tDCS
Title
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Description
normalized number of movement units (representing severity of dyskinesia). Unit: units/mm
Time Frame
Within one week right before the 1st session of tDCS
Title
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Description
normalized number of movement units (representing severity of dyskinesia). Unit: units/mm
Time Frame
Within one week right after the 8th (last) session of tDCS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Mei Wang, PhD
Phone
852-27664197
Email
shumei.wang@polyu.edu.hk
Facility Information:
Facility Name
Hong Kong Polytechnic University
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Mei Wang, PhD
Phone
852-27664197
Email
shumei.wang@polyu.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset
We'll reach out to this number within 24 hrs