Negative Symptoms, Schizophrenia, Transcranial Alternating Current Stimulations
Conditions
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.
Interventions
DEVICEtranscranial alternating current stimulation (NE Starstim)
dual-channel theta-tACS over right DLPFC and cerebellum simultaneously
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 PANSS total scores | At 1 week and 3 weeks | changes of PANSS total scores before and after active or sham 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 |
| 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 |
Countries
China
Outcome results
None listed