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

D

Dr WANG Shumei

Status

Enrolling

Conditions

Psychosis
Schizophrenia
Parkinsonism
Dyskinesias

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04086160
HSEARS20190518001

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

12 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 8 patient groups

schizophrenia- tDCS
Experimental group
Treatment:
Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)
schizophrenia- sham
Sham Comparator group
Treatment:
Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)
at risk- tDCS
Experimental group
Treatment:
Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)
at risk- sham
Sham Comparator group
Treatment:
Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)
healthy controls for schizophrenia- tDCS
Experimental group
Treatment:
Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)
healthy controls for schizophrenia- sham
Sham Comparator group
Treatment:
Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)
healthy controls for at risk- tDCS
Experimental group
Treatment:
Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)
healthy controls for at risk- sham
Sham Comparator group
Treatment:
Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)

Trial contacts and locations

1

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Central trial contact

Shu-Mei Wang, PhD

Data sourced from clinicaltrials.gov

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