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

NCT04086160 | Unknown

• 1 other identifier: HSEARS20190518001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Psychosis; Parkinsonism; Dyskinesias

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (8)

schizophrenia- tDCS

EXPERIMENTAL

Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)

schizophrenia- sham

SHAM COMPARATOR

Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)

at risk- tDCS

EXPERIMENTAL

Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)

at risk- sham

SHAM COMPARATOR

Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)

healthy controls for schizophrenia- tDCS

EXPERIMENTAL

Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)

healthy controls for schizophrenia- sham

SHAM COMPARATOR

Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)

healthy controls for at risk- tDCS

EXPERIMENTAL

Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)

healthy controls for at risk- sham

SHAM COMPARATOR

Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)

Interventions

Transcranial direct current stimulation device (Soterix Medical, New York, NY) DEVICE

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.

at risk- sham; at risk- tDCS; healthy controls for at risk- sham; healthy controls for at risk- tDCS; healthy controls for schizophrenia- sham; healthy controls for schizophrenia- tDCS; schizophrenia- sham; schizophrenia- tDCS

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Dr WANG Shumei: lead

Study Sites (1)

Hong Kong Polytechnic University

Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Parkinsonian Disorders; Dyskinesias

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shu-Mei Wang, PhD

CONTACT

852-27664197; shumei.wang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2019
• First Posted: September 11, 2019
• Study Start: August 22, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)