Back to resultsTranscranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
eldith DC-stimulator (neuroconn, Ilmenau, Germany)
eldith DC-stimulator (Neuroconn, Ilmenau, Germany)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, negative syndrome, PANSS
Eligibility Criteria
Inclusion Criteria:
- schizophrenic patients with a negative syndrome. PANSS > 40.
Exclusion Criteria:
- other psychiatric or neurologic diseases.
Sites / Locations
- Klinik fuer Psychiatrie
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
sham
active
Arm Description
patients receive sham tDCS stimulation
active transcranial direct current stimulation
Outcomes
Primary Outcome Measures
SANS reduction
decrease by 30%
Secondary Outcome Measures
neuropsychological tests
increase in SOPT by 30% increase in TMT by 30%
Full Information
NCT ID
NCT01378078
First Posted
June 16, 2011
Last Updated
July 19, 2013
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT01378078
Brief Title
Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia
Official Title
Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, negative syndrome, PANSS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sham
Arm Type
Sham Comparator
Arm Description
patients receive sham tDCS stimulation
Arm Title
active
Arm Type
Active Comparator
Arm Description
active transcranial direct current stimulation
Intervention Type
Device
Intervention Name(s)
eldith DC-stimulator (neuroconn, Ilmenau, Germany)
Intervention Description
daily tDCS treatment over left DLPFC, 20 min, 2 mA
Intervention Type
Device
Intervention Name(s)
eldith DC-stimulator (Neuroconn, Ilmenau, Germany)
Intervention Description
same as sham stimulation
Primary Outcome Measure Information:
Title
SANS reduction
Description
decrease by 30%
Time Frame
4 weeks after baseline
Secondary Outcome Measure Information:
Title
neuropsychological tests
Description
increase in SOPT by 30% increase in TMT by 30%
Time Frame
4 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
schizophrenic patients with a negative syndrome. PANSS > 40.
Exclusion Criteria:
other psychiatric or neurologic diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Palm, MD
Organizational Affiliation
Ludwig Maximilian University Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik fuer Psychiatrie
City
Munich
ZIP/Postal Code
80336
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia
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