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

NCT04859504 | Completed DMC

• 1 other identifier: 20191836
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia; Transcranial Alternating Current Stimulations; Negative Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• changes of PANSS total scores

  At 1 week and 3 weeks

• cognitive functioning changes using MCCB

  At 1 week and 3 weeks

• changes of P300 activity

  At 1 week

• changes of MMN activity

  At 1 week

• changes of power of resting-state EEG activity

  At 1 day and 1 week

Study Arms (2)

Active tACS

ACTIVE COMPARATOR

Active tACS will be applied twice daily for 5 days. In each session, dual-channel high-density theta(7Hz) tACS stimulations will be delivered over the right DLPFC (one anodal electrode at F4, between -1.2mA and 1.2 mA; two cathodal electrodes at AF4 and FC6, between -0.6mA and 0.6mA) and cerebellum (one anodal electrode at Oz, between -1 mA and 1mA; two cathodal electrodes at PO3 and PO4, between -0.5mA and 0.5mA) lasting 20 minutes.

Device: transcranial alternating current stimulation (NE Starstim)

Sham tACS

SHAM COMPARATOR

Sham tACS will be also applied twice daily for 5 days.The parameters of tACS electrodes numbers, locations, and current duration are all the same with active tACS. But sham tACS begin with a fade in over 3s to the peak, followed immediately by no current stimulation for 20 minutes and a fade out of 3s.

Device: transcranial alternating current stimulation (NE Starstim)

Interventions

transcranial alternating current stimulation (NE Starstim) DEVICE

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

Active tACS; Sham tACS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (2)

Zhengjiang Mental Health Center

Zhenjiang, Jiangsu, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Related 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.

  PMID: 30696271 BACKGROUND

• 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.

  PMID: 30962628 BACKGROUND

• 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.

  PMID: 31806403 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Yingying Tang, PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

• Jianhua Sheng, PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 26, 2021
• Study Start: April 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-07

Locations

CN (2)