Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia

July 19, 2013 updated by: Daniel Keeser, Ludwig-Maximilians - University of Munich
Transcranial direct current stimulation (tDCS) showed beneficial effects on cognition in healthy subjects and depressed patients. In this study, patients with treatment resistant negative syndrome in schizophrenia will be treated with direct current stimulation. fMRI measures will be performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80336
        • Klinik fuer Psychiatrie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • schizophrenic patients with a negative syndrome. PANSS > 40.

Exclusion Criteria:

  • other psychiatric or neurologic diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: sham
patients receive sham tDCS stimulation
Device: eldith DC-stimulator (neuroconn, Ilmenau, Germany)
daily tDCS treatment over left DLPFC, 20 min, 2 mA
Active Comparator: active
active transcranial direct current stimulation
Device: eldith DC-stimulator (Neuroconn, Ilmenau, Germany)
same as sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SANS reduction
Time Frame: 4 weeks after baseline
decrease by 30%
4 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neuropsychological tests
Time Frame: 4 weeks after baseline
increase in SOPT by 30% increase in TMT by 30%
4 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Investigators

  • Principal Investigator: Ulrich Palm, MD, Ludwig Maximilian University Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (Estimate)

June 22, 2011

Study Record Updates

Last Update Posted (Estimate)

July 22, 2013

Last Update Submitted That Met QC Criteria

July 19, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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