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Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Auditory Hallucinations

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sham stimulation
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, auditory hallucinations, transcranial stimulation, tDCS, tACS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina at Chapel Hill, Outpatient STEP Clinic
  • University of North Carolina, Wake STEP Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

transcranial direct current stimulation (tDCS)

Sham stimulation

Arm Description

13 subjects total. 2mA stimulation for 20 minutes.

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.

Outcomes

Primary Outcome Measures

Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5
Examining AHRS total score after 5 days of stimulation compared to baseline assessment total.

Secondary Outcome Measures

Persistence of Decrease in AHRS Score Over Time
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.

Full Information

First Posted
October 13, 2013
Last Updated
January 25, 2016
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01963676
Brief Title
Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia
Official Title
Clinical Trial to Assess Transcranial Current Stimulation as a Treatment for Medication Refractory Auditory Hallucinations in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Auditory Hallucinations
Keywords
schizophrenia, auditory hallucinations, transcranial stimulation, tDCS, tACS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transcranial direct current stimulation (tDCS)
Arm Type
Experimental
Arm Description
13 subjects total. 2mA stimulation for 20 minutes.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Primary Outcome Measure Information:
Title
Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5
Description
Examining AHRS total score after 5 days of stimulation compared to baseline assessment total.
Time Frame
Baseline, Day 5
Secondary Outcome Measure Information:
Title
Persistence of Decrease in AHRS Score Over Time
Description
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.
Time Frame
Day 5, One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavio Frohlich, PhD
Organizational Affiliation
University of North Carolina at Chapel Hill, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill, Outpatient STEP Clinic
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7250
Country
United States
Facility Name
University of North Carolina, Wake STEP Clinic
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22581236
Citation
Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091. Erratum In: Am J Psychiatry. 2012 Dec 1;169(12):1321.
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Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

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