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

Shanghai Mental Health Center

Status: Completed

Conditions: Transcranial Alternating Current Stimulations; Schizophrenia; Negative Symptoms

Treatments: Device: transcranial alternating current stimulation (NE Starstim)

Study type: Interventional

Funder types: Other

Identifiers

NCT04859504

20191836

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Active tACS

Active Comparator group

Description:

Active tACS will be applied twice daily for 5 days. In each session, dual-channel high-density theta(7Hz) tACS stimulations will be delivered over the right DLPFC (one anodal electrode at F4, between -1.2mA and 1.2 mA; two cathodal electrodes at AF4 and FC6, between -0.6mA and 0.6mA) and cerebellum (one anodal electrode at Oz, between -1 mA and 1mA; two cathodal electrodes at PO3 and PO4, between -0.5mA and 0.5mA) lasting 20 minutes.

Treatment:

Device: transcranial alternating current stimulation (NE Starstim)

Sham tACS

Sham Comparator group

Description:

Sham tACS will be also applied twice daily for 5 days.The parameters of tACS electrodes numbers, locations, and current duration are all the same with active tACS. But sham tACS begin with a fade in over 3s to the peak, followed immediately by no current stimulation for 20 minutes and a fade out of 3s.

Treatment:

Device: transcranial alternating current stimulation (NE Starstim)