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

NCT01623726 | Withdrawn Phase 2

• 1 other identifier: CAISM-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transcranial Direct Current Stimulation; Schizophrenia

Keywords

Transcranial Direct Current Stimulation; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Negative Symptoms Rates as assessed by the PAANS

  Comparison between follow u and baseline PAANS scores with emphasis in negative symptoms scores

  Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Positive and Negative Syndrome Scale (PAANS)

Secondary Outcomes (4)

• Mental Mini Exam

  Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive Screening assessment as performed by the Mental Mini Exam

• Moca rating Scale

  Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by MoCa Test

• Stroop Victoria

  Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by Stroop - Victoria version

• Neuropsychological Assessment

  Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - neuropsychologial assessment by trained researcher

Study Arms (2)

tDCS active

EXPERIMENTAL

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)

tDCS sham

PLACEBO COMPARATOR

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)

Interventions

Transcranial Direct Current Stimulation (tDCS) PROCEDURE

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.

tDCS active; tDCS sham

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Centro de Atenção Integrada à Saúde Mental

São Paulo, São Paulo, 01415001, Brazil

Location

Related Publications (16)

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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

• Andre R Brunoni, PhD

  Irmandade da Santa Casa de Misericórdia de São Paulo

  STUDY CHAIR

• Pedro Shiozawa, MD

  Irmandade da Santa Casa de Misericóridia de São Paulo

  PRINCIPAL INVESTIGATOR

• Quirino Jr Cordeiro, PhD

  Irmandade da Santa Casa de Misericórdia de São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 20, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2014
• Last Updated: December 16, 2013

Record last verified: 2013-12

Locations

BR (1)