Non-invasive Brain Stimulation for Auditory Verbal Hallucinations in Schizophrenia

August 13, 2016 updated by: Andres Neuhaus, MD, Charite University, Berlin, Germany

The Mechanism of Non-invasive Brain Stimulation for Therapy of Chronic Auditory Verbal Hallucinations in Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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
      • Berlin, Germany, 10117
        • Charite University Medicine
      • Berlin, Germany, 12203
        • Charite University Medicine

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: verum tDCS
left-hemispheric tDCS: anode placed midway between F3 and FP1, cathode placed midway between T3 and P3
Device: tDCS
active vs. sham tDCS left hemisphere
Other Names:
  • device: neuroConn tDCS PLUS device
Sham Comparator: sham tDCS
left-hemispheric sham tDCS: anode placed midway between F3 and FP1, cathode placed midway between T3 and P3
Device: tDCS
active vs. sham tDCS left hemisphere
Other Names:
  • device: neuroConn tDCS PLUS device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Auditory Hallucination Rating Scale score
Time Frame: baseline; 3 days after intervention; 3 months after intervention
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
baseline; 3 days after intervention; 3 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive And Negative Syndrome Scale
Time Frame: baseline; 3 days after intervention; 3 months after intervention
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
baseline; 3 days after intervention; 3 months after intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
N1 suppression during talking and listening
Time Frame: baseline; 3 days after intervention
N1 suppression during talking and listening will be assessed at baseline; change thereof at 3 days after intervention is further outcome measure
baseline; 3 days after intervention
Diffusion Tensor Imaging: Fractional anisotropy of longitudinal superior fascicle and arcuate fascicle
Time Frame: baseline; 3 days after intervention
Fractional anisotropy of longitudinal superior fascicle and arcuate fascicle will be assessed at baseline; change thereof 3 days after intervention is further outcome measure
baseline; 3 days after intervention
Default Mode Network connectivity
Time Frame: baseline; 3 days after intervention
Default Mode Network connectivity will be assessed at baseline; change thereof 3 days after intervention is further outcome measure
baseline; 3 days after intervention

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Robert Lindenberg, MD, Department of Neurology, Charité University Medicine Berlin
  • Principal Investigator: Andres H. Neuhaus, MD, Department of Psychiatry, Charité University Medicine Berlin

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

March 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 13, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4/123/12

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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