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

NCT01623726 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-12-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Andre R Brunoni, PhD · Irmandade da Santa Casa de Misericórdia de São Paulo

  • Pedro Shiozawa, MD · Irmandade da Santa Casa de Misericóridia de São Paulo

  • Quirino Jr Cordeiro, PhD · Irmandade da Santa Casa de Misericórdia de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-08-31
Completion
2014-08-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01623726 on ClinicalTrials.gov