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

Schizophrenia Clinical Trial

Official title:

Dual-channel Transcranial Alternating Current Stimulations Targeting Negative Symptoms in Schizophrenia Patients: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04859504
• Other study ID #: 20191836
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Shanghai Mental Health Center
• Contact: Yingying Tang, PhD
• Phone: 86-21-34773230
• Email: yytang0522[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Negative Symptoms
• Schizophrenia

Intervention

Device:
• transcranial alternating current stimulation (NE Starstim)
dual-channel theta-tACS over right DLPFC and cerebellum simultaneously

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Zhengjiang Mental Health Center	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reductive ratio of PANSS-negative symptoms scores	differences of reductive ratio of PANSS-negative symptoms scores after between active and sham tACS	At 1 week and 3 weeks
Secondary	changes of PANSS total scores	changes of PANSS total scores before and after active or sham tACS	At 1 week and 3 weeks
Secondary	cognitive functioning changes using MCCB	changes of MCCB scores before and after active or sham tACS	At 1 week
Secondary	changes of P300 activity	changes of P300 activity at baseline and after 10-session tACS	At 1 week
Secondary	changes of MMN activity	changes of MMN activity at baseline and after 10-session tACS	At 1 week
Secondary	changes of power of resting-state EEG activity	changes of power of resting-state EEG activity at baseline, after 1-session tACS and after 10-session tACS	At 1 day and 1 week
Secondary	centroid value from fNIRS recording before and after active or sham tACS	centroid value from fNIRS recording before and after active or sham tACS	At 1 week
Secondary	Integral value from fNIRS recording before and after active or sham tACS	Intergral value from fNIRS recording before and after active or sham tACS	At 1 week