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

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

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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)