Developing Dual-channel Transcranial Alternating Current Stimulations Targeting Negative Symptoms in Schizophrenia

Not Applicable

Completed

• Conditions: Transcranial Alternating Current Stimulations; Negative Symptoms; Schizophrenia

• Registration Number: NCT04859504
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

Negative symptoms are core symptoms in schizophrenia which play an important role in clinical outcomes and impede patients to return to society. Anti-psychotic medicines have shown limited effect in improving negative symptoms and cognitive functioning, whereas non-invasive neuromodulations, i.e. , transcranial alternating current stimulation (tACS), have shown promising potentials. Recently new evidence of brain structural and functional alterations has been provided by neuroimaging studies. Brady RO et al. found cerebellar-prefrontal network connectivity was related to negative symptoms in schizophrenia. It provides clues for developing a new tACS protocol targeting improving negative symptoms, in which dual-channel high-density alternating current stimulations were delivered over both the right dorsolateral prefrontal cortex and cerebellum simultaneously.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-26
• Status Verified: 2024-07
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Last Update Submitted: 2024-12-08
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• meet the DSM-V diagnostic criteria for schizophrenia;
• present with prominent negative symptoms with PANSS-negative scores >20, at least one score of PANSS N1-N7 >3, and reductive ratio of PANSS-negative in the past two weeks before recruitment <10%;
• stable usage and dosage of anti-psychotic medicines in the past two weeks and during the tACS intervention.
• age within 18-60;
• illness duration >1year;
• education at least 6 years;
• written consent of receiving tACS intervention.

Exclusion Criteria

• Meet any DSM-V diagnostic criteria of any other psychiatric disorders besides schizophrenia ;
• any history of alcohol or substance dependence in the past 3 months;
• any other major physical disease (i.e., Sensorimotor disorder, neurological disease);
• any metal implants or any other tACS contraindication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
reductive ratio of PANSS-negative symptoms scores	At 1 week and 3 weeks	differences of reductive ratio of PANSS-negative symptoms scores after between active and sham tACS

Secondary Outcome Measures

Name	Time	Method
changes of PANSS total scores	At 1 week and 3 weeks	changes of PANSS total scores before and after active or sham tACS
cognitive functioning changes using MCCB	At 1 week and 3 weeks	changes of MCCB scores before and after active or sham tACS
changes of P300 activity	At 1 week	changes of P300 activity at baseline and after 10-session tACS
changes of MMN activity	At 1 week	changes of MMN activity at baseline and after 10-session tACS
changes of power of resting-state EEG activity	At 1 day and 1 week	changes of power of resting-state EEG activity at baseline, after 1-session tACS and after 10-session tACS
centroid value from fNIRS recording before and after active or sham tACS	At 1 week	centroid value from fNIRS recording before and after active or sham tACS
Integral value from fNIRS recording before and after active or sham tACS	At 1 week	Intergral value from fNIRS recording before and after active or sham tACS

Trial Locations

Locations (2)

Zhengjiang Mental Health Center; 🇨🇳 Zhenjiang, Jiangsu, China

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China