Clinical trial NCT04859504: Developing Dual-channel Transcranial Alternating Current Stimulations Targeting Negative Symptoms in Schizophrenia
Official title: Dual-channel Transcranial Alternating Current Stimulations Targeting Negative Symptoms in Schizophrenia Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Transcranial Alternating Current Stimulations
Negative Symptoms
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: reductive ratio of PANSS-negative symptoms scores
timeFrame: At 1 week and 3 weeks
Secondary outcomes:
measure: changes of PANSS total scores
timeFrame: At 1 week and 3 weeks
measure: cognitive functioning changes using MCCB
timeFrame: At 1 week and 3 weeks
measure: changes of P300 activity
timeFrame: At 1 week
measure: changes of MMN activity
timeFrame: At 1 week
measure: changes of power of resting-state EEG activity
timeFrame: At 1 day and 1 week
measure: centroid value from fNIRS recording before and after active or sham tACS
timeFrame: At 1 week
measure: Integral value from fNIRS recording before and after active or sham tACS
timeFrame: At 1 week
Other outcomes:
Locations:
city: Zhenjiang
country: China
facility: Zhengjiang Mental Health Center
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Yingying Tang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Mental Health Center
name: Jianhua Sheng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brady RO Jr, Gonsalvez I, Lee I, Ongur D, Seidman LJ, Schmahmann JD, Eack SM, Keshavan MS, Pascual-Leone A, Halko MA. Cerebellar-Prefrontal Network Connectivity and Negative Symptoms in Schizophrenia. Am J Psychiatry. 2019 Jul 1;176(7):512-520. doi: 10.1176/appi.ajp.2018.18040429. Epub 2019 Jan 30.
citation: Reinhart RMG, Nguyen JA. Working memory revived in older adults by synchronizing rhythmic brain circuits. Nat Neurosci. 2019 May;22(5):820-827. doi: 10.1038/s41593-019-0371-x. Epub 2019 Apr 8.
citation: Smith RC, Md WL, Wang Y, Jiang J, Wang J, Szabo V, Faull R, Jin H, Davis JM, Li C. Effects of transcranial direct current stimulation on cognition and symptoms in Chinese patients with schizophrenia✰. Psychiatry Res. 2020 Feb;284:112617. doi: 10.1016/j.psychres.2019.112617. Epub 2019 Nov 2.