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Trial record 40 of 3313 for:    schizophrenia

TDCS for Auditory Hallucinations in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01898299
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : April 2, 2018
Stanley Medical Research Institute
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief Summary:
The purpose of the present research is to test a potential new treatment for auditory verbal hallucinations in schizophrenia that uses transcranial Direct Current Stimulation (tDCS), a neurostimulation technique that passes an extremely weak electric current through the brain. During the treatment, two electrodes are positioned on the scalp above regions of the brain implicated in abnormal cortical activity associated with auditory verbal hallucinations in schizophrenia. Due to the directional flow of current, one electrode, termed "cathodal",inhibits cortical activity, and the other, termed "anodal", increases cortical activity. These electrodes will be placed such that cathodal stimulation is applied to an area associated with hyperactivity and anodal stimulation to an area associated with hypoactivity. One preliminary study has revealed that this form of neurostimulation can alleviate auditory verbal hallucination symptoms both immediately following five days of treatment and up to three months after the final treatment. The goal of this study is to replicate these effects and explore the mechanisms that may underpin them.

Condition or disease Intervention/treatment Phase
Schizophrenia Device: transcranial Direct Current Stimulation (tDCS) Device: Sham tDCS Not Applicable

Detailed Description:

90 patients with persistent auditory verbal hallucinations will be recruited to this study. Each individual will participate in behavioral assessments lasting up to 3 hours each and will then be randomized to receive a series of active vs. sham tDCS treatments. For active treatment, patients will have the inhibitory (cathodal) tDCS electrode placed over left auditory cortex relative to an anodal placed over frontal cortex on the right side. tDCS treatments will take place for 20 min per day for 5 consecutive days. For sham, procedures will be similar except that sham (inactive) tDCS treatment will be used. Assessment batteries will then be repeated following completion of treatment and at 1 and 3 mo following treatment. In addition, patients will be offered the possibility to participate in a concurrent magnetic resonance imaging (MRI) study aimed at evaluating the effects of tDCS on activation of auditory cortex during an auditory discrimination task as well as on other imaging parameters related to resting brain activity and metabolism. Patients who agree to participate in this MRI study will be scanned before and after active or sham tDCS. In addition, 5-15 schizophrenia patients will complete a week of High-density, e.g., "high-definition" tDCS (HD-tDCS) open label.

In addition to hallucinating patients, we will recruit up to 20 healthy controls and 20 non-hallucinating patients, who will have similar assessments to the patients, but will not receive tDCS.

Overall, the investigators hypothesize that tDCS treatment will lead to reduction in hallucinations, improvement in auditory function, and change in EEG and MRI measurements so that patients more closely resemble healthy volunteers and non-hallucinating patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: tDCS for Auditory Hallucinations in Schizophrenia
Actual Study Start Date : May 2013
Actual Primary Completion Date : December 14, 2017
Actual Study Completion Date : January 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation (tDCS) treatments will take place for 20 minutes per day for 5 consecutive days
Device: transcranial Direct Current Stimulation (tDCS)
A neurostimulation technique that passes an extremely weak electric current through the brain.
Other Name: BrainStim SYS

Sham Comparator: Sham tDCS
Sham tDCS(inactive)treatment (transcranial Direct Current Stimulation) will take place for 20 minutes per day for 5 consecutive days.
Device: Sham tDCS
Sham (inactive) tDCS treatment

Primary Outcome Measures :
  1. Severity of refractory auditory hallucinations [ Time Frame: Change from baseline in Auditory Hallucination Rating Scale after 5 day treatment ]
    Auditory hallucinations as determined by Auditory Hallucinations Rating Scale (AHRS)

Secondary Outcome Measures :
  1. Severity of negative schizophrenia symptoms [ Time Frame: Change from baseline in Positive and Negative Symptom Scale after 5 day treatment ]
    Negative schizophrenia symptoms will be measures using the Positive and Negative Symptom Scale (PANSS)

Other Outcome Measures:
  1. Auditory function [ Time Frame: Comparing baseline to after 5 days of treatment ]
    Optional outcome: Increased amplitude of the auditory steady-state response (ASSR) and N1 auditory event-related potential (ERP) component as well as increased corollary discharge modulation of the N1 auditory ERP produced when patients produce versus listen to speech and auditory word recognition task

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age between 18-55
  • Structured Clinical Interview for DSM Disorders (SCID) primary diagnosis of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-Version IV) schizophrenia or schizoaffective disorder
  • Persistent auditory verbal hallucinations
  • Right handed
  • Stable antipsychotic medication for > 4 weeks
  • Normal hearing
  • If female and not infertile, must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment, an interuterine device (IUD) which was implanted at least 2 months prior to screening, or "double-barrier" contraception
  • Willing/capacity to provide informed consent

Exclusion Criteria:

  • Substance dependence or abuse (excluding nicotine) in the past 90 days
  • Current significant laboratory abnormality
  • History of seizure, epilepsy in self or fist degree relatives, stroke, brain surgery, head injury with loss of consciousness > 1 hour or clear cognitive sequelae, intracranial metal implants, known structural brain lesion, devices that may be affected by transcranial Direct Current Stimulation (tDCS) (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
  • Frequent and persistent migraines
  • History of adverse reaction to neurostimulation or open skin wounds that would preclude safe placement of tDCS electrodes
  • Participation in study of investigational medication/device within 4 weeks
  • Current use of medications known to lower seizure threshold (lithium, serotonergic or tricyclic antidepressants)
  • If female, pregnant or breast feeding at the time of screening
  • For MRI study only: Claustrophobia or metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan, as determined according to the guidelines set forth in the following reference book: "Guide to MR procedures and metallic objects" Shellock, PhD, Lippincott-Raven press, NY 1998

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01898299

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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Nathan Kline Institute
Orangeburg, New York, United States, 10962
Sponsors and Collaborators
New York State Psychiatric Institute
Stanley Medical Research Institute
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Principal Investigator: Daniel C Javitt, MD Nathan Kline Institute, New York State Psychiatric Institute

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: New York State Psychiatric Institute Identifier: NCT01898299     History of Changes
Other Study ID Numbers: 6662
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Keywords provided by New York State Psychiatric Institute:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms