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

Primary Purpose

Schizophrenia, Transcranial Alternating Current Stimulations, Negative Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcranial alternating current stimulation (NE Starstim)
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yingying TangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tACS

Sham tACS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

changes of PANSS total scores
changes of PANSS total scores before and after active or sham tACS
cognitive functioning changes using MCCB
changes of MCCB scores before and after active or sham tACS
changes of P300 activity
changes of P300 activity at baseline and after 10-session tACS
changes of MMN activity
changes of MMN activity at baseline and after 10-session tACS
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
centroid value from fNIRS recording before and after active or sham tACS
centroid value from fNIRS recording before and after active or sham tACS
Integral value from fNIRS recording before and after active or sham tACS
Intergral value from fNIRS recording before and after active or sham tACS

Full Information

First Posted
April 1, 2021
Last Updated
September 21, 2021
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT04859504
Brief Title
Developing Dual-channel Transcranial Alternating Current Stimulations Targeting Negative Symptoms in Schizophrenia
Official Title
Dual-channel Transcranial Alternating Current Stimulations Targeting Negative Symptoms in Schizophrenia Patients: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Transcranial Alternating Current Stimulations, Negative Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tACS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham tACS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
transcranial alternating current stimulation (NE Starstim)
Intervention Description
dual-channel theta-tACS over right DLPFC and cerebellum simultaneously
Primary Outcome Measure Information:
Title
reductive ratio of PANSS-negative symptoms scores
Description
differences of reductive ratio of PANSS-negative symptoms scores after between active and sham tACS
Time Frame
At 1 week and 3 weeks
Secondary Outcome Measure Information:
Title
changes of PANSS total scores
Description
changes of PANSS total scores before and after active or sham tACS
Time Frame
At 1 week and 3 weeks
Title
cognitive functioning changes using MCCB
Description
changes of MCCB scores before and after active or sham tACS
Time Frame
At 1 week
Title
changes of P300 activity
Description
changes of P300 activity at baseline and after 10-session tACS
Time Frame
At 1 week
Title
changes of MMN activity
Description
changes of MMN activity at baseline and after 10-session tACS
Time Frame
At 1 week
Title
changes of power of resting-state EEG activity
Description
changes of power of resting-state EEG activity at baseline, after 1-session tACS and after 10-session tACS
Time Frame
At 1 day and 1 week
Title
centroid value from fNIRS recording before and after active or sham tACS
Description
centroid value from fNIRS recording before and after active or sham tACS
Time Frame
At 1 week
Title
Integral value from fNIRS recording before and after active or sham tACS
Description
Intergral value from fNIRS recording before and after active or sham tACS
Time Frame
At 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingying Tang, PhD
Phone
86-21-34773230
Email
yytang0522@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Sheng, MD
Phone
86-21-34773459
Email
shengjianhua66@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingying Tang, PhD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianhua Sheng, PhD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yingying Tang
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingying Tang, PhD
Phone
86-21-34773230
Email
yytang0522@gmail.com
First Name & Middle Initial & Last Name & Degree
Jianhua Sheng, MD
Phone
86-21-34773759
Email
shengjianhua66@163.com
First Name & Middle Initial & Last Name & Degree
Yingying Tang, PhD
First Name & Middle Initial & Last Name & Degree
Jianhua Sheng, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We will decide IPD or not when the clinical trial is completed.
Citations:
PubMed Identifier
30696271
Citation
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.
Results Reference
background
PubMed Identifier
30962628
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.
Results Reference
background
PubMed Identifier
31806403
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.
Results Reference
background

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

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