TDCS for Auditory Hallucinations in Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01898299
First received: June 12, 2013
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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 (1-3). 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(4). The goal of this study is to replicate these effects and explore the mechanisms that may underpin them.


Condition Intervention
Schizophrenia
Device: transcranial Direct Current Stimulation (tDCS)
Device: Sham tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: tDCS for Auditory Hallucinations in Schizophrenia

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Severity of refractory auditory hallucinations [ Time Frame: Change from baseline in Auditory Hallucination Rating Scale after 5 day treatment ] [ Designated as safety issue: No ]
    Auditory hallucinations as determined by Auditory Hallucinations Rating Scale (AHRS)


Secondary Outcome Measures:
  • Severity of negative schizophrenia symptoms [ Time Frame: Change from baseline in Positive and Negative Symptom Scale after 5 day treatment ] [ Designated as safety issue: No ]
    Negative schizophrenia symptoms will be measures using the Positive and Negative Symptom Scale (PANSS)


Other Outcome Measures:
  • Auditory function [ Time Frame: Comparing baseline to after 5 days of treatment ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 45
Study Start Date: May 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

45 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 have the option to participate in electroencephalography (EEG) and 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. On some days (days 1 and 5), EEG may be collected during the tDCS stimulation. 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 to hallucinating patients, we will recruit up to 20 healthy controls and 20 non-hallucinating patients, who will have similar EEG assessments to the patients, but will not receive tDCS. These subjects will participate in only one EEG session, lasting a total of 3 hrs. Overall, the investigators hypothesize that tDCS treatment will lead to reduction in hallucinations, improvement in auditory function, and change in EEG so that patients more closely resemble healthy volunteers and non-hallucinating patients.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898299

Contacts
Contact: Daniel C Javitt, MD 845-398-6546 dcj2113@columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Joshua T Kantrowitz, MD    646-774-6738    kantrow@nyspi.columbia.edu   
Nathan Kline Institute Recruiting
Orangeburg, New York, United States, 10962
Sponsors and Collaborators
New York State Psychiatric Institute
Stanley Medical Research Institute
Investigators
Principal Investigator: Daniel C Javitt, MD Nathan Kline Institute, New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01898299     History of Changes
Other Study ID Numbers: 6662
Study First Received: June 12, 2013
Last Updated: January 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
Schizophrenia

Additional relevant MeSH terms:
Hallucinations
Schizophrenia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014