Schizophrenia Clinical Trial
Official title:
Dual-channel Transcranial Alternating Current Stimulations Targeting Negative Symptoms in Schizophrenia Patients: A Randomized Clinical Trial
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Mental Health Center | Shanghai | Shanghai |
China | Zhengjiang Mental Health Center | Zhenjiang | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Shanghai Mental Health Center |
China,
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
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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