Developing Dual-channel Transcranial Alternating Current Stimulations Targeting Negative Symptoms in Schizophrenia
- Conditions
- Transcranial Alternating Current StimulationsNegative SymptomsSchizophrenia
- Interventions
- Device: transcranial alternating current stimulation (NE Starstim)
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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
- Arm && Interventions
Group Intervention Description Sham tACS transcranial alternating current stimulation (NE Starstim) 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. Active tACS transcranial alternating current stimulation (NE Starstim) 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.
- 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