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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04859504
Other study ID # 20191836
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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