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CompletedNCT01801787Updated Aug 16, 2016

Non-invasive Brain Stimulation for Auditory Verbal Hallucinations in Schizophrenia

An interventional study of tDCS in Auditory Verbal Hallucinations and Schizophrenia, sponsored by Charite University, Berlin, Germany. Completed at 2 sites in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-08-16.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Auditory Verbal Hallucinations
  • Schizophrenia
03

In context

Hallucinations

135 studies on the registry are indexed under Hallucinations; 36 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 115 interventional studies indexed under Hallucinations.

Browse Hallucinations studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    verum tDCS

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

    Device: tDCS

  • Sham comparator
    sham tDCS

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

    Device: tDCS

Interventions

  • DevicetDCS

    active vs. sham tDCS left hemisphere

    Also known as: device: neuroConn tDCS PLUS device

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline; 3 days after intervention; 3 months after intervention

Secondary outcomes

  1. 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

    Time frame: baseline; 3 days after intervention; 3 months after intervention

Other outcomes

  1. N1 suppression during talking and listening

    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

  2. Diffusion Tensor Imaging: Fractional anisotropy of longitudinal superior fascicle and arcuate fascicle

    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

  3. Default Mode Network connectivity

    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

07

Study locations

2 sites
  • Charité University Medicine
    Berlin, 10117, Germany
  • Charité University Medicine
    Berlin, 12203, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2013, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2013
First posted
Mar 1, 2013
Start
Mar 2013
Primary completionActual
Dec 2015
CompletionActual
Dec 2015
Last update
Aug 16, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01801787
Responsible party
Andres Neuhaus, MD (M.D., Charite University, Berlin, Germany) — Principal investigator
First posted
Mar 1, 2013
Start date
Mar 2013
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Aug 16, 2016

Study contacts

Robert Lindenberg, MD
principal investigator · Department of Neurology, Charité University Medicine Berlin
Andres H. Neuhaus, MD
principal investigator · Department of Psychiatry, Charité University Medicine Berlin
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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