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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04086160
• Other study ID #: HSEARS20190518001
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: The Hong Kong Polytechnic University
• Contact: Shu-Mei Wang, PhD
• Phone: 852-27664197
• Email: shumei.wang[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Parkinsonian Disorders
• Parkinsonism
• Psychosis
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Hong Kong Polytechnic University	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Dr WANG Shumei

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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