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Non-invasive Brain Stimulation for Auditory Verbal Hallucinations in Schizophrenia

Primary Purpose

Auditory Verbal Hallucinations, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
tDCS
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Auditory Verbal Hallucinations

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of schizophrenia
  • chronic auditory verbal hallucinations
  • right-handed

Exclusion Criteria:

  • drug abuse other than nicotine
  • severe cognitive deficits
  • severe medical conditions
  • severe neurological disorders
  • severe microangiopathy
  • history of electroconvulsive therapy
  • pregnancy or lactation

Sites / Locations

  • Charité University Medicine
  • Charité University Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

verum tDCS

sham tDCS

Arm Description

left-hemispheric tDCS: anode placed midway between F3 and FP1, cathode placed midway between T3 and P3

left-hemispheric sham tDCS: anode placed midway between F3 and FP1, cathode placed midway between T3 and P3

Outcomes

Primary Outcome Measures

Change of Auditory Hallucination Rating Scale score
Auditory Hallucination Rating Scale score will be assessed at baseline; changes thereof at 3 days after intervention and 3 months after intervention are primary outcome measures

Secondary Outcome Measures

Positive And Negative Syndrome Scale
Positive And Negative Syndrome Scale score will be assessed at baseline; changes thereof at 3 days after intervention and 3 months after intervention are secondary outcome measures

Full Information

First Posted
February 26, 2013
Last Updated
August 13, 2016
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01801787
Brief Title
Non-invasive Brain Stimulation for Auditory Verbal Hallucinations in Schizophrenia
Official Title
The Mechanism of Non-invasive Brain Stimulation for Therapy of Chronic Auditory Verbal Hallucinations in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

5. Study Description

Brief Summary
The current study investigates the basic principles that underlie the efficacy of transcranial direct current stimulation for chronic auditory verbal hallucinations in schizophrenia in a multimodal design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Verbal Hallucinations, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
verum tDCS
Arm Type
Experimental
Arm Description
left-hemispheric tDCS: anode placed midway between F3 and FP1, cathode placed midway between T3 and P3
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
left-hemispheric sham tDCS: anode placed midway between F3 and FP1, cathode placed midway between T3 and P3
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
device: neuroConn tDCS PLUS device
Intervention Description
active vs. sham tDCS left hemisphere
Primary Outcome Measure Information:
Title
Change of Auditory Hallucination Rating Scale score
Description
Auditory Hallucination Rating Scale score will be assessed at baseline; changes thereof at 3 days after intervention and 3 months after intervention are primary outcome measures
Time Frame
baseline; 3 days after intervention; 3 months after intervention
Secondary Outcome Measure Information:
Title
Positive And Negative Syndrome Scale
Description
Positive And Negative Syndrome Scale score will be assessed at baseline; changes thereof at 3 days after intervention and 3 months after intervention are secondary outcome measures
Time Frame
baseline; 3 days after intervention; 3 months after intervention
Other Pre-specified Outcome Measures:
Title
N1 suppression during talking and listening
Description
N1 suppression during talking and listening will be assessed at baseline; change thereof at 3 days after intervention is further outcome measure
Time Frame
baseline; 3 days after intervention
Title
Diffusion Tensor Imaging: Fractional anisotropy of longitudinal superior fascicle and arcuate fascicle
Description
Fractional anisotropy of longitudinal superior fascicle and arcuate fascicle will be assessed at baseline; change thereof 3 days after intervention is further outcome measure
Time Frame
baseline; 3 days after intervention
Title
Default Mode Network connectivity
Description
Default Mode Network connectivity will be assessed at baseline; change thereof 3 days after intervention is further outcome measure
Time Frame
baseline; 3 days after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of schizophrenia chronic auditory verbal hallucinations right-handed Exclusion Criteria: drug abuse other than nicotine severe cognitive deficits severe medical conditions severe neurological disorders severe microangiopathy history of electroconvulsive therapy pregnancy or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Lindenberg, MD
Organizational Affiliation
Department of Neurology, Charité University Medicine Berlin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andres H. Neuhaus, MD
Organizational Affiliation
Department of Psychiatry, Charité University Medicine Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité University Medicine
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité University Medicine
City
Berlin
ZIP/Postal Code
12203
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Non-invasive Brain Stimulation for Auditory Verbal Hallucinations in Schizophrenia

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