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Completed

NCT Number: NCT01801787

Non-invasive Brain Stimulation for 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.

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Key information

Conditions

Auditory Verbal Hallucinations Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité University Medicine, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Device

active vs. sham tDCS left hemisphere

Other names: device: neuroConn tDCS PLUS device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 1, 2013
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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