Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963676
• Other study ID #: 13-2995
• Status: Completed
• Phase: N/A
• First received: October 13, 2013
• Last updated: January 25, 2016
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: January 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Auditory Hallucinations
• Hallucinations
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Device:
• tDCS

• Sham stimulation

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill, Outpatient STEP Clinic	Chapel Hill	North Carolina
United States	University of North Carolina, Wake STEP Clinic	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Day 5	No
Secondary	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.	Day 5, One month	No