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High-Definition Transcranial Direct Current Stimulation as a Treatment of Negative Symptoms of Schizophrenia

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HD-tDCS
Sham HD-tDCS
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, HD-tDCS, negative symptoms

Eligibility Criteria

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

Inclusion Criteria:

  • patients with diagnostic schizophrenia by DSM-IV
  • patients at an age between 18-60 years of Han nationality
  • 1) baseline score equal or higher than 4 in at least two items in negative symptoms at PANSS; 2) or baseline score equal or higher than 3 points in at least 1/3 items (including apathy) for negative symptoms; and 3)No more than 2 items have a score higher than 3 points for positive symptoms at PANSS.
  • willing to participate in the experiment and take treatment

Exclusion Criteria:

  • other psychiatric diagnoses
  • criteria for bipolar disorder; dementia; other psychotic disturbs; substance-related disorders
  • schizophrenia caused by organic diseases
  • other mental disorders caused by drugs and alcohol
  • IQ<70
  • presence of serious suicidal behaviour
  • claustrophobic or pregnancy
  • metal implantation in vivo
  • specific tDCS limitations (such as anatomic problems and high sensitivity on current)

Sites / Locations

  • Shanghai Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

HD-tDCS group

Sham HD-tDCS group

Arm Description

This HD-tDCS group will be stimulated by active HD-tDCS.

This sham HD-tDCS group will have a sham stimulation with HD-tDCS.

Outcomes

Primary Outcome Measures

The Positive and Negative Syndrome Scale (PANSS)
a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale.
The Scale for the Assessment of Negative Symptoms (SANS)
a 24-items, 5-point rating scale; the 5 rating points represent increasing levels of psychopathology: 0= absent, 1= mild, 2= moderate, 3= severe, 4= extreme; of the 24 items, the first 6 items for Affective Flattening, 5 items for Alogia, 5 items for Avolition, 5 items for Anhedonia, and the remaining 3 items for Attention.
The Clinical Assessment Interview for Negative Symptoms (CAINS)
including CAINS and CAINS self-reported checklist

Secondary Outcome Measures

the Temporal Experience of Pleasure Scale (TEPS)
a self-reported questionnaire
the Emotional Expression Scale (EES)
a self-reported questionnaire
the Belief About Pleasure Scales (BAPS)
a self-reported questionnaire
the Emotional Regulation Questionnaire (ERQ)
a self-reported questionnaire
the Beck Depression Inventory (BDI)
a self-reported questionnaire
the Effort Expenditure for Rewards Task (EEfRT)
a computer test
the Belief Updating Task
a computer test
the Anticipatory and Consummatory Pleasure (ACP) task performances
a computer test

Full Information

First Posted
June 27, 2018
Last Updated
August 18, 2021
Sponsor
Shanghai Mental Health Center
Collaborators
Chinese Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03602716
Brief Title
High-Definition Transcranial Direct Current Stimulation as a Treatment of Negative Symptoms of Schizophrenia
Official Title
A Research on High-Definition Transcranial Direct Current Stimulation as a Treatment of Negative Symptoms in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Study was recruited slowly due to the imapct of some uncontrollable factors, such as COVID19.
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
September 26, 2020 (Actual)
Study Completion Date
September 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Chinese Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, investigators designed a double-blind randomized trial to prove a more reliable evidence to show how the treatment by using high-definition transcranial direct current stimulation (HD-tDCS) can relieve negative symptoms in patients with predominant negative symptoms of schizophrenia, especially on improving participants' anhedonia condition and social cognition, through stimulating the left dorsolateral prefrontal cortex (DLPFC). Participants will be divided into active and sham HD-tDCS groups equally.
Detailed Description
Schizophrenia is one of the most disabling psychiatric disorders that almost 1% worldwide population suffer from this devastating illness. The clinical expression of this illness has been categorized into different dimensions, though most of the patients are well treated with antipsychotic medication, the negative symptom is still one of the very refractory symptoms. Emerging evidence shows that transcranial direct current stimulation (tDCS) is a promising treatment for schizophrenia negative symptoms, however, findings are still controversial. HD-tDCS can provide a more stable and accurate direct current comparing with traditional tDCS, which gives a hope to treat negative symptoms in a more reliable way. An association between negative symptoms and grey matter reductions in the prefrontal cortex is found, moreover, even during rest, hypoactivity of the prefrontal cortex, particularly of the left dorsolateral, and of the anterior cingulate regions, has been linked to negative symptoms of schizophrenia. It has been observed that tDCS could relatively alleviate negative symptoms in patients with schizophrenia by stimulating the left DLPFC through an anodal electrode, which has been proved can also modulate brain functional connectivity and have clinical improvements. Half of the participants with a clinical presentation of predominant negative symptoms will be stimulated by active HD-tDCS and the rest will have a sham stimulation. HD-tDCS is going to be delivered at 1.5 mA intensity for 20 minutes once a day; sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at 1 (T2) and 3 (T3) months. A Soterix Medical 4x1 HD-tDCS will be used with the anode placed over the left DLPFC (F3), surrounded by four cathodal electrodes at F5, F1, FC3 and AF3, based on the 10/20 international EEG system. All the outcomes will be assessed at baseline (T0, before HD-tDCS sessions), one day after the 10th HD-tDCS sessions (T1), and also at T2 and T3. Both participants and investigators will be blind to this treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, HD-tDCS, negative symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HD-tDCS group
Arm Type
Experimental
Arm Description
This HD-tDCS group will be stimulated by active HD-tDCS.
Arm Title
Sham HD-tDCS group
Arm Type
Sham Comparator
Arm Description
This sham HD-tDCS group will have a sham stimulation with HD-tDCS.
Intervention Type
Device
Intervention Name(s)
HD-tDCS
Intervention Description
HD-tDCS is going to be delivered at 1.5 mA intensity for 20 minutes once a day (+15 s fade-in and fade-out); sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. HD-tDCS will be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system.
Intervention Type
Device
Intervention Name(s)
Sham HD-tDCS
Intervention Description
HD-tDCS is going to be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system; sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. This group will have a 20-min-sham stimulation.
Primary Outcome Measure Information:
Title
The Positive and Negative Syndrome Scale (PANSS)
Description
a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale.
Time Frame
Change from baseline through study completion and sustained effects at 1 and 3 months.
Title
The Scale for the Assessment of Negative Symptoms (SANS)
Description
a 24-items, 5-point rating scale; the 5 rating points represent increasing levels of psychopathology: 0= absent, 1= mild, 2= moderate, 3= severe, 4= extreme; of the 24 items, the first 6 items for Affective Flattening, 5 items for Alogia, 5 items for Avolition, 5 items for Anhedonia, and the remaining 3 items for Attention.
Time Frame
Change from baseline through study completion and sustained effects at 1 and 3 months.
Title
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Description
including CAINS and CAINS self-reported checklist
Time Frame
Change from baseline through study completion and sustained effects at 1 and 3 months.
Secondary Outcome Measure Information:
Title
the Temporal Experience of Pleasure Scale (TEPS)
Description
a self-reported questionnaire
Time Frame
Change from baseline through study completion and sustained effects at 1 and 3 months.
Title
the Emotional Expression Scale (EES)
Description
a self-reported questionnaire
Time Frame
Change from baseline through study completion and sustained effects at 1 and 3 months.
Title
the Belief About Pleasure Scales (BAPS)
Description
a self-reported questionnaire
Time Frame
Change from baseline through study completion and sustained effects at 1 and 3 months.
Title
the Emotional Regulation Questionnaire (ERQ)
Description
a self-reported questionnaire
Time Frame
Change from baseline through study completion and sustained effects at 1 and 3 months.
Title
the Beck Depression Inventory (BDI)
Description
a self-reported questionnaire
Time Frame
Change from baseline through study completion and sustained effects at 1 and 3 months.
Title
the Effort Expenditure for Rewards Task (EEfRT)
Description
a computer test
Time Frame
Change from baseline through study completion and sustained effects at 1 and 3 months.
Title
the Belief Updating Task
Description
a computer test
Time Frame
Change from baseline through study completion and sustained effects at 1 and 3 months.
Title
the Anticipatory and Consummatory Pleasure (ACP) task performances
Description
a computer test
Time Frame
Change from baseline through study completion and sustained effects at 1 and 3 months.

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: patients with diagnostic schizophrenia by DSM-IV patients at an age between 18-60 years of Han nationality 1) baseline score equal or higher than 4 in at least two items in negative symptoms at PANSS; 2) or baseline score equal or higher than 3 points in at least 1/3 items (including apathy) for negative symptoms; and 3)No more than 2 items have a score higher than 3 points for positive symptoms at PANSS. willing to participate in the experiment and take treatment Exclusion Criteria: other psychiatric diagnoses criteria for bipolar disorder; dementia; other psychotic disturbs; substance-related disorders schizophrenia caused by organic diseases other mental disorders caused by drugs and alcohol IQ<70 presence of serious suicidal behaviour claustrophobic or pregnancy metal implantation in vivo specific tDCS limitations (such as anatomic problems and high sensitivity on current)
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

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High-Definition Transcranial Direct Current Stimulation as a Treatment of Negative Symptoms of Schizophrenia

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