Transcranial Direct Current Stimulation (tDCS) as Therapeutical Strategy for Negative Symptoms in Schizophrenia

This study has been withdrawn prior to enrollment.
(To be submitted for grant application)
Sponsor:
Information provided by (Responsible Party):
Andre Brunoni, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01623726
First received: June 8, 2012
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

The current research is aimed at using Transcranial Direct Current Stimulation (tDCS) as complementary therapeutic tool in the treatment of schizophrenia. Patients will be randomized into two groups (tDCS-active x tDCS-sham) accordingly to detailed protocol. Main outcome will be measured by specific clinical rating scales based on the assessment of negative symptoms. A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes shall include collateral effects evaluation, anxiety and depressive scales as well as clinical monitoring.


Condition Intervention Phase
Transcranial Direct Current Stimulation
Schizophrenia
Procedure: Transcranial Direct Current Stimulation (tDCS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) as Therapeutical Strategy for Negative Symptoms in Schizophrenia: a Double-blind Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Negative Symptoms Rates as assessed by the PAANS [ Time Frame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Positive and Negative Syndrome Scale (PAANS) ] [ Designated as safety issue: No ]
    Comparison between follow u and baseline PAANS scores with emphasis in negative symptoms scores


Secondary Outcome Measures:
  • Mental Mini Exam [ Time Frame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive Screening assessment as performed by the Mental Mini Exam ] [ Designated as safety issue: No ]
    cognitive evaluation as assessed by the Mental Mini Exam

  • Moca rating Scale [ Time Frame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by MoCa Test ] [ Designated as safety issue: No ]
    comparison between follow up and baseline scores in Cognitive evaluation as assessed by MoCa Test

  • Stroop Victoria [ Time Frame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by Stroop - Victoria version ] [ Designated as safety issue: No ]
    comparison between follow up and baseline scores in atention and inhibitory control as assessed by Stroop Victoria

  • Neuropsychological Assessment [ Time Frame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - neuropsychologial assessment by trained researcher ] [ Designated as safety issue: No ]
    comparison between follow up and baseline scores in neuropschological evaluations performed by specialist using SuperLab tool


Enrollment: 0
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tDCS active
Active tDCS as foreseen in research protocol: daily sessions for 10 days with 2mA intensity stimulation during 20 minutes.
Procedure: Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation. Daily sessions with a total of 10 days intervention. Each intervention will take place with a 2mA intensity during 20 minutes. The current will be delivered by "Chattanooga Iontophoresis Dual Channel Delivery Device", that stands for a 2-channels tDCS device in which previous dosage can be set as default to maintain frequently used treatment parameters. Main features include (a) Beeping alerts if electrode fault for open current or high impedance, low battery, treatment completion or power left on; (b)automatic 30 second current ramp up and down during power on/off keeps patient comfortable; (c) Current can be set in 0.1 mA increments between 0.5 mA and 4 mA.
Placebo Comparator: tDCS sham
Sham tDCS : as foreseen in research protocol: sham stimulation with initial stimulation followed by turning off the device during the same time of intervention as to guarantee blinding
Procedure: Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation. Daily sessions with a total of 10 days intervention. Each intervention will take place with a 2mA intensity during 20 minutes. The current will be delivered by "Chattanooga Iontophoresis Dual Channel Delivery Device", that stands for a 2-channels tDCS device in which previous dosage can be set as default to maintain frequently used treatment parameters. Main features include (a) Beeping alerts if electrode fault for open current or high impedance, low battery, treatment completion or power left on; (b)automatic 30 second current ramp up and down during power on/off keeps patient comfortable; (c) Current can be set in 0.1 mA increments between 0.5 mA and 4 mA.

Detailed Description:

Overview

The present study is a double-blind randomized clinical trial in which patients should be allocated from a General Psychiatry Service into two groups (tDCS-active x tDCS-sham). Subjects who fulfilled eligibility criteria will undergo ten days of consecutive stimulation (active or sham) and will return after two to four weeks for final clinical assessment. Patients who shown no response in rating scales and that were allocated to sham intervention group will be able to choose whether or not they want to undergo the active intervention at follow up (partial cross-over)

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with age between 18-59 years
  • diagnostic of Schizophrenia or Schizoaffective Disorder as stated by DSM-IV and confirmed by SCID (Structured Clinical Interview for DSMIV), to be tested by a psychiatrist
  • baseline score higher than 20 for negative symptoms at PAAN
  • patients able to read and understand Portuguese.

Exclusion Criteria:

  • other psychiatric diagnosis
  • criteria for bipolar disorder; dementia; other psychotic disturbs; substance related disorders
  • presence of other severe neurological or clinical diseases
  • presence of suicidal behavior (planning or attempt in the previous 4 weeks)
  • pregnancy
  • incapacity of coping with the informed consent
  • specific tDCS limitations (such as anatomic problems)

Regarding medication: all patients should have stable dosology of medications for at least 6 weeks

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623726

Locations
Brazil
Centro de Atenção Integrada à Saúde Mental
São Paulo, SP, Brazil, 01415001
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: Andre R Brunoni, PhD Irmandade da Santa Casa de Misericórdia de São Paulo
Principal Investigator: Pedro Shiozawa, MD Irmandade da Santa Casa de Misericóridia de São Paulo
Study Director: Quirino Jr Cordeiro, PhD Irmandade da Santa Casa de Misericórdia de São Paulo
  More Information

Publications:

Responsible Party: Andre Brunoni, Prof. Dr., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01623726     History of Changes
Other Study ID Numbers: CAISM-001
Study First Received: June 8, 2012
Last Updated: December 13, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Transcranial Direct Current Stimulation
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014