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Completed

NCT Number: NCT04859504

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Negative Symptoms Schizophrenia Spectrum and Other Psychotic Disorders Transcranial Alternating Current Stimulations

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhengjiang Mental Health Center, Zhenjiang, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transcranial alternating current stimulation (NE Starstim)

Device

dual-channel theta-tACS over right DLPFC and cerebellum simultaneously

Primary outcomes

  1. reductive ratio of PANSS-negative symptoms scores

    Time frame: At 1 week and 3 weeks

    differences of reductive ratio of PANSS-negative symptoms scores after between active and sham tACS

Secondary outcomes

  1. changes of PANSS total scores

    Time frame: At 1 week and 3 weeks

    changes of PANSS total scores before and after active or sham tACS

  2. cognitive functioning changes using MCCB

    Time frame: At 1 week and 3 weeks

    changes of MCCB scores before and after active or sham tACS

  3. changes of P300 activity

    Time frame: At 1 week

    changes of P300 activity at baseline and after 10-session tACS

  4. changes of MMN activity

    Time frame: At 1 week

    changes of MMN activity at baseline and after 10-session tACS

  5. changes of power of resting-state EEG activity

    Time frame: 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

  6. centroid value from fNIRS recording before and after active or sham tACS

    Time frame: At 1 week

    centroid value from fNIRS recording before and after active or sham tACS

  7. Integral value from fNIRS recording before and after active or sham tACS

    Time frame: At 1 week

    Intergral value from fNIRS recording before and after active or sham tACS

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2021
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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