Effects of RAS in SZ

Shu-Mei Wang

Status: Not yet enrolling

Conditions: Schizophrenia and Schizoaffective Disorder

Treatments: Behavioral: Upper-limb movement training; Behavioral: RAS incorporated in upper-limb movement training

Study type: Interventional

Funder types: Other

Identifiers

NCT07086040

RAS in SZ

Details and patient eligibility

About

The two main groups of medicated patients with schizophrenia (SZ) are those receiving second-generation antipsychotics and those receiving first-generation antipsychotics. The purpose of this research project is to target each patient group to examine effects of rhythmic auditory stimulation (RAS) on upper-limb movements in medicated SZ patients in a 6-month follow-up period.

The main questions of this project are:

1. Does RAS reduce severity of upper-limb bradykinesia (slow movements) and dyskinesia (repetitive and involuntary movements) after intervention, at 3-month follow-up and 6-month follow-up in SZ patients receiving second-generation antipsychotics? and
2. Does RAS reduce severity of upper-limb bradykinesia and dyskinesia after intervention, at 3-month follow-up and 6-month follow-up in SZ patients receiving first-generation antipsychotics?

Researchers will compare upper-limb movement training with the aid of RAS to upper-limb movement training without the aid of RAS to see if RAS works to improve upper-limb movements in SZ patients. Participants will:

1. Undergo an interview and movement tests and fill out questionnaires before and after the movement training program and at 3-month follow-up and 6-month follow-up; and
2. Receive movement training for 40 minutes per session for a total of 21 sessions.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

[For SZ patients]

Inclusion Criteria:

• A diagnosis of schizophrenia or schizoaffective disorder
• Between 18 to 60 years old
• Keeping the same antipsychotics and the same dosage at least 4 weeks right before joining the study
• A Edinburgh Handedness Inventory score of > 60
• A Montreal Cognitive Assessment score of ≥ 24

Exclusion Criteria:

• Substance abuse or drug abuse
• Neurological diseases or medical conditions that affect upper-limb movements and hearing
• Other psychiatric diagnoses in addition to a diagnosis of schizophrenia or schizoaffective disorder

[For healthy participants]

Inclusion Criteria:

• Between 18 to 60 years old
• A Edinburgh Handedness Inventory score of > 60
• A Montreal Cognitive Assessment score of ≥ 24

Exclusion Criteria:

• Substance abuse or drug abuse
• Neurological diseases or medical conditions that affect upper-limb movements and hearing
• Psychiatric diagnoses
• Taking psychotropic medications
• Presence of first-degree relatives or siblings with diagnoses of psychiatric diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 4 patient groups

SZ patients receiving second-generation antipsychotics + RAS

Experimental group

Description:

SZ patients receiving second-generation antipsychotics: Provision of upper-limb movement training with the aid of RAS

Treatment:

Behavioral: RAS incorporated in upper-limb movement training

SZ patients receiving second-generation antipsychotics + no RAS

Active Comparator group

Description:

SZ patients receiving second-generation antipsychotics: Provision of upper-limb movement training without the aid of RAS

Treatment:

Behavioral: Upper-limb movement training

SZ patients receiving first-generation antipsychotics + RAS

Experimental group

Description:

SZ patients receiving first-generation antipsychotics: Provision of upper-limb movement training with the aid of RAS

Treatment:

Behavioral: RAS incorporated in upper-limb movement training

SZ patients receiving first-generation antipsychotics + no RAS

Active Comparator group

Description:

SZ patients receiving first-generation antipsychotics: Provision of upper-limb movement training without the aid of RAS

Treatment:

Behavioral: Upper-limb movement training