Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

January 25, 2016 updated by: Flavio Frohlich, PhD, University of North Carolina, Chapel Hill

Clinical Trial to Assess Transcranial Current Stimulation as a Treatment for Medication Refractory Auditory Hallucinations in Schizophrenia

Investigating the effect of non-invasive transcranial current stimulation on auditory hallucinations in patients with schizophrenia. Normal neuronal activity is perturbed in schizophrenia, so selective targeting of this abnormal activity could serve as a treatment for schizophrenia and alleviate symptoms caused by abnormal neuronal activity, such as auditory hallucinations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

AIM 1: To evaluate the effect of transcranial direct current stimulation (tDCS) (2mA for 20min on five consecutive days) on auditory hallucinations in schizophrenia patients using the change in ratings on the Auditory Hallucination Rating Scale (AHRS) by patients before and after stimulation. We hypothesize that tDCS will modulate the abnormal neuronal activity found in schizophrenic patients and thereby decrease their auditory hallucinations when measured after stimulation.

AIM 2: To evaluate the long term effects of tDCS by having patients give a rating on the AHRS after one month has passed since stimulation and comparing this value to their baseline score and their score immediately after stimulation. We hypothesize that there will remain a significant reduction in auditory hallucination score in participants who received tDCS at one month.

Study Type

Interventional

Enrollment (Actual)

26

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
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7250
        • University of North Carolina at Chapel Hill, Outpatient STEP Clinic
      • Raleigh, North Carolina, United States, 27610
        • University of North Carolina, Wake STEP Clinic

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnostic and Statistical Manual IV (DSM-IV) diagnosis of schizophrenia, any subtype, or schizoaffective disorder, with refractory auditory hallucinations. Duration of illness >1 year.
  • 18-99 years old.
  • Clinically stable for at least 12 weeks, i.e. not requiring hospitalization or a change in level of care .
  • On current antipsychotic doses for approximately 4 weeks or more.
  • Capacity to understand all relevant risks and potential benefits of the study (informed consent) OR has a legal guardian who can complete consent forms on the patients behalf
  • Right handed

Exclusion Criteria:

  • Subjects with a DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months.
  • History of significant head injury/trauma, as defined by loss of consciousness for more than 1 hour, or recurring seizures, or requiring later cognitive rehabilitation or causing cognitive sequelae.
  • Prior brain surgery.
  • Any brain devices/implants, including cochlear implants and aneurysm clips.
  • Co-morbid neurological condition (i.e. seizure disorder, brain tumor).
  • Medical or neurological illness (unstable cardiac disease AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation.
  • Non English speakers.
  • Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: transcranial direct current stimulation (tDCS)
13 subjects total. 2mA stimulation for 20 minutes.
Device: tDCS
SHAM_COMPARATOR: Sham stimulation
13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Device: Sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5
Time Frame: Baseline, Day 5
Examining AHRS total score after 5 days of stimulation compared to baseline assessment total.
Baseline, Day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence of Decrease in AHRS Score Over Time
Time Frame: Day 5, One month
We will re-assess patients one month after the completion of stimulation to evaluate whether their change from baseline to day 5 score on the AHRS persisted over time, namely 30 days.
Day 5, One month

Collaborators and Investigators

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

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Flavio Frohlich, PhD, University of North Carolina at Chapel Hill, Department of Psychiatry

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

January 1, 2014

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

October 13, 2013

First Submitted That Met QC Criteria

October 13, 2013

First Posted (ESTIMATE)

October 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-2995

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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