NCT01898299

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 23, 2020

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

5.2 years

First QC Date

June 12, 2013

Results QC Date

January 31, 2020

Last Update Submit

March 19, 2020

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Severity of Refractory Auditory Hallucinations

    Total score: Auditory hallucinations as determined by Auditory Hallucinations Rating Scale (AHRS). This is a seven item scale rating auditory hallucinations. Total score ranges from 1 to 41, with higher scores more severe.

    Auditory Hallucination Rating Scale score after one month

Study Arms (2)

Transcranial Direct Current Stimulation

EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS) treatments will take place for 20 minutes per day for 5 consecutive days

Device: transcranial Direct Current Stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

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

Device: Sham tDCS

Interventions

transcranial Direct Current Stimulation (tDCS)DEVICE

A neurostimulation technique that passes an extremely weak electric current through the brain.

Also known as: BrainStim SYS
Transcranial Direct Current Stimulation
Sham tDCSDEVICE

Sham (inactive) tDCS treatment

Sham tDCS

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Nathan Kline Institute

Orangeburg, New York, 10962, United States

Location

Related Publications (1)

  • Kantrowitz JT, Sehatpour P, Avissar M, Horga G, Gwak A, Hoptman MJ, Beggel O, Girgis RR, Vail B, Silipo G, Carlson M, Javitt DC. Significant improvement in treatment resistant auditory verbal hallucinations after 5 days of double-blind, randomized, sham controlled, fronto-temporal, transcranial direct current stimulation (tDCS): A replication/extension study. Brain Stimul. 2019 Jul-Aug;12(4):981-991. doi: 10.1016/j.brs.2019.03.003. Epub 2019 Mar 5.

    PMID: 30922713DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Results Point of Contact

Title
Joshua Kantrowitz
Organization
New York State Psychiatric Institute
jk3380@cumc.columbia.edu
6467746738

Study Officials

  • Daniel C Javitt, MD

    Nathan Kline Institute, New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychiatrist

Study Record Dates

First Submitted

June 12, 2013

First Posted

July 12, 2013

Study Start

May 1, 2013

Primary Completion

July 14, 2018

Study Completion

August 14, 2018

Last Updated

March 23, 2020

Results First Posted

March 23, 2020

Record last verified: 2020-03

Locations

US(2)