Transcranial Direct Current Stimulation for Hallucinations in First-Episode Schizophrenia

March 9, 2018 updated by: Deepak Sarpal, Northwell Health
The purpose of this study is to test the efficacy of transcranial direct current stimulation (tDCS) for the treatment of auditory hallucinations in patients currently on risperidone treatment who are experiencing recent onset psychosis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study looks to investigate whether patients with recent onset psychosis may benefit from tDCS treatment. The main hypothesis to be tested in this study is that treatment with risperidone supplemented with tDCS will yield a decrease in auditory hallucinations and negative symptoms; and improve working memory and attention.

To test this hypothesis the investigators will enroll 30 patients with recent-onset psychosis into a 16-week long randomized double blind controlled study of risperidone treatment supplemented with tDCS versus risperidone plus sham tDCS. Patients who present for treatment of a first psychotic episode with a schizophrenia spectrum diagnosis and who are eligible to undergo or are already on treatment with risperidone, will be randomized to either tDCS or sham tDCS twice a day for five consecutive days. Neuropsychological testing, Magnetic Resonance Imaging (MRI) and electroencephalogram (EEG) will be conducted at baseline, week 1 (after completion of tDCS or sham tDCS intervention) and week 16. Clinical interviews to assess symptoms and medical assessments for side effects will be done at baseline, weekly for the first four weeks and then every two weeks until study completion. The primary outcome measure will be the Auditory Hallucinations Rating Scale (AHRS) score.

Specific aims are:

To determine the efficacy of tDCS for auditory hallucinations in patients with first episode schizophrenia. The investigators hypothesize that risperidone plus tDCS is associated with a faster and more robust decrease in auditory hallucinations compared to risperidone plus sham tDCS.

To test the efficacy of tDCS in cognitive and negative symptoms in patients with first episode schizophrenia. The investigators hypothesize that tDCS improves working memory, attention/vigilance and decreases negative symptoms.

To examine the neuronal basis of tDCS effects in ameliorating auditory hallucinations in schizophrenia by conducting event-related potential (ERP) and resting state EEG. The investigators hypothesize that the Delta N-100 amplitude is associated with improvement of auditory hallucinations after tDCS treatment.

To determine the effects of tDCS on brain structure and function by conducting structural MRI, diffusion tensor imaging (DTI) and functional magnetic resonance imaging (fMRI).

Study Type

Interventional

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

  • United States
    • New York
      • Glen Oaks, New York, United States, 11004
        • Zucker-Hillside 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

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. current Diagnostic and Statistical Manual-IV (DSM-IV) -defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, psychosis NOS as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First et al, 1994).
  2. does not meet DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder with psychotic features.
  3. current positive symptoms rated ≥4 (moderate) on one or more of these BPRS (Woerner et al., 1988) items: conceptual disorganization, grandiosity, hallucinatory behavior, unusual thought content
  4. current positive symptoms rated ≥4 (moderate) on one or more of these BPRS (Woerner et al., 1988) items: conceptual disorganization, grandiosity or unusual thought content and is in the first episode of the illness as defined by having taken antipsychotic medications for a cumulative lifetime period of 4 weeks or less,
  5. age 15 to 40.
  6. competent and willing to sign informed consent.
  7. for women, negative pregnancy test and agreement to use a medically accepted birth control method.

Exclusion Criteria:

  1. serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain.
  2. any medical condition which requires treatment with a medication with psychotropic effects.
  3. significant risk of suicidal or homicidal behavior;
  4. cognitive or language limitations, or any other factor that would preclude subjects providing informed consent.
  5. medical contraindications to treatment with risperidone (e.g. neuroleptic malignant syndrome with prior risperidone exposure).
  6. lack of response to a prior adequate trial of risperidone.
  7. requires treatment with an antidepressant or mood stabilizing medication.
  8. presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system.
  9. damaged skin at the site of stimulation (i.e. skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.).

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
Active Comparator: Active comparator: tDCS & Risperidone
In the active arm, active tDCS will be applied using a Soterix Medical 1x1 line tDCS Model 1300 low-intensity stimulator at a current of 2 milliampere (mA) for 20 minutes, twice a day for five consecutive days, for a total of 10 sessions.
Drug: Risperidone
The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Device: tDCS
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which sub-threshold transcranial electric current (in the range of 0.4-2 mA) is applied via two conductive saline soaked electrodes placed on the scalp using a Soterix Medical 1x1 line tDCS Model 1300 low-intensity stimulator.
Sham Comparator: Sham comparator: tDCS & Risperidone
In the sham arm, active tDCS will be applied using a Soterix Medical 1x1 line tDCS Model 1300 low-intensity stimulator at a current of 2mA for 1 minute, twice a day for five consecutive days, for a total of 10 sessions.
Drug: Risperidone
The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Device: tDCS
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which sub-threshold transcranial electric current (in the range of 0.4-2 mA) is applied via two conductive saline soaked electrodes placed on the scalp using a Soterix Medical 1x1 line tDCS Model 1300 low-intensity stimulator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auditory hallucinations
Time Frame: 16 Weeks
A decrease in verbal auditory hallucinations based on the Auditory Hallucinations Ratings Scale (AHRS).
16 Weeks

Collaborators and Investigators

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

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Deepak Sarpal, M.D., Northwell Health

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

February 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 22, 2016

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 15-0701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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