tDCS & Auditory Hallucinations in Schizophrenia

November 1, 2016 updated by: Herzog Hospital

tDCS & Auditory Hallucinations in Schizophrenia (AVH-SZ)

The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral prefrontal cortex.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

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

  • Israel
      • Jerusalem, Israel, 9103702
        • Herzog Hospital

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 18-60
  • Primary diagnosis of Diagnostic and Statistical Manual, fifth edition, schizophrenia
  • Persistent auditory verbal hallucinations
  • Right handed
  • Under stable doses of antipsychotic medication for ≥4 weeks
  • Normal hearing by self-report and physical exam
  • Use of effective method of birth control for women of childbearing capacity
  • Capable to provide informed consent. For patients judged to be incapable to provide informed consent the legal guardian of the patient must agree to participation in the study and provide signed informed consent

Exclusion Criteria:

  • Current or past history of substance dependence or abuse (excluding nicotine)
  • Other current Axis I disorders
  • History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
  • Frequent and persistent migraines
  • History of adverse reaction to neurostimulation
  • Participation in study of investigational medication within 6 weeks
  • Pregnancy
  • Women who are breast-feeding
  • Current significant laboratory abnormality

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active tDCS
active tDCS
Device: Active tDCS
repetitive daily tDCS sessions for a period of one week
Sham Comparator: control
sham (placebo) tDCS condition
Device: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline in auditory hallucination rating scale
Time Frame: 1 week post-treatment
1 week post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
change in self-report quality of life scale from baseline
Time Frame: 1 week post treatment
1 week post treatment

Other Outcome Measures

Outcome Measure
Time Frame
change from baseline in auditory event related potentials (ERP)
Time Frame: change in auditory ERP from baseline at 1 week
change in auditory ERP from baseline at 1 week

Collaborators and Investigators

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

Sponsor

Herzog Hospital

Investigators

  • Principal Investigator: Oded Meiron, PhD, Sarah Herzog Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 28, 2014

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Meiron 2013-3

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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