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

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ClinicalTrials.gov Identifier: NCT01378078
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : July 22, 2013
Sponsor:
Information provided by (Responsible Party):
Daniel Keeser, Ludwig-Maximilians - University of Munich

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Device: eldith DC-stimulator (neuroconn, Ilmenau, Germany) Device: eldith DC-stimulator (Neuroconn, Ilmenau, Germany) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia
Study Start Date : June 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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




Primary Outcome Measures :
  1. SANS reduction [ Time Frame: 4 weeks after baseline ]
    decrease by 30%


Secondary Outcome Measures :
  1. neuropsychological tests [ Time Frame: 4 weeks after baseline ]
    increase in SOPT by 30% increase in TMT by 30%



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • other psychiatric or neurologic diseases.

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): NCT01378078


Locations
Germany
Klinik fuer Psychiatrie
Munich, Germany, 80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Ulrich Palm, MD Ludwig Maximilian University Munich

Responsible Party: Daniel Keeser, Ph.D., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01378078     History of Changes
Other Study ID Numbers: 04/2011
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: July 22, 2013
Last Verified: July 2013

Keywords provided by Daniel Keeser, Ludwig-Maximilians - University of Munich:
schizophrenia
negative syndrome
PANSS

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders