Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03602716
Recruitment Status : Enrolling by invitation
First Posted : July 27, 2018
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Chinese Academy of Sciences
Information provided by (Responsible Party):
Shanghai Mental Health Center

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Device: HD-tDCS Device: Sham HD-tDCS Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Research on High-Definition Transcranial Direct Current Stimulation as a Treatment of Negative Symptoms in Patients With Schizophrenia
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: HD-tDCS group
This HD-tDCS group will be stimulated by active HD-tDCS.
Device: HD-tDCS
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.

Sham Comparator: Sham HD-tDCS group
This sham HD-tDCS group will have a sham stimulation with HD-tDCS.
Device: Sham HD-tDCS
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 Measures :
  1. The Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Change from baseline through study completion and sustained effects at 1 and 3 months. ]
    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.

  2. The Scale for the Assessment of Negative Symptoms (SANS) [ Time Frame: Change from baseline through study completion and sustained effects at 1 and 3 months. ]
    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.

  3. The Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: Change from baseline through study completion and sustained effects at 1 and 3 months. ]
    including CAINS and CAINS self-reported checklist


Secondary Outcome Measures :
  1. the Temporal Experience of Pleasure Scale (TEPS) [ Time Frame: Change from baseline through study completion and sustained effects at 1 and 3 months. ]
    a self-reported questionnaire

  2. the Emotional Expression Scale (EES) [ Time Frame: Change from baseline through study completion and sustained effects at 1 and 3 months. ]
    a self-reported questionnaire

  3. the Belief About Pleasure Scales (BAPS) [ Time Frame: Change from baseline through study completion and sustained effects at 1 and 3 months. ]
    a self-reported questionnaire

  4. the Emotional Regulation Questionnaire (ERQ) [ Time Frame: Change from baseline through study completion and sustained effects at 1 and 3 months. ]
    a self-reported questionnaire

  5. the Beck Depression Inventory (BDI) [ Time Frame: Change from baseline through study completion and sustained effects at 1 and 3 months. ]
    a self-reported questionnaire

  6. the Effort Expenditure for Rewards Task (EEfRT) [ Time Frame: Change from baseline through study completion and sustained effects at 1 and 3 months. ]
    a computer test

  7. the Belief Updating Task [ Time Frame: Change from baseline through study completion and sustained effects at 1 and 3 months. ]
    a computer test

  8. the Anticipatory and Consummatory Pleasure (ACP) task performances [ Time Frame: Change from baseline through study completion and sustained effects at 1 and 3 months. ]
    a computer test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with diagnostic schizophrenia by DSM-V
  • patients at an age between 18-60 years of Han nationality
  • baseline score higher than 4 in at least three items or higher than 5 in at least two items for negative symptoms at PANSS; or baseline score higher than 3 points in at least 1/3 items (including apathy) for negative symptoms. No more than 2 items have a score higher than 3 points for positive symptoms at PANSS.
  • in items of negative symptoms, at least 1/3 of them get a score greater than 3 points especially the item of apathy. No more than two items have a higher score than 3 points for positive symptoms 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602716


Locations
Layout table for location information
China, Shanghai
Shanghai Mental Health Center
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Mental Health Center
Chinese Academy of Sciences

Layout table for additonal information
Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03602716     History of Changes
Other Study ID Numbers: 17411970000
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: April 2018

Layout table for additional information
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
Keywords provided by Shanghai Mental Health Center:
schizophrenia
HD-tDCS
negative symptoms
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders