Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

NCT ID: NCT01963676

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-10-31

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Auditory Hallucinations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

transcranial direct current stimulation (tDCS)

13 subjects total. 2mA stimulation for 20 minutes.

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

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.

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: DEVICE

Interventions

tDCS

Intervention Type: DEVICE

Sham stimulation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Flavio Frohlich, PhD

Assistant Professor, Departments of Psychiatry, Cell Biology and Physiology, and Biomedical Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flavio Frohlich, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina at Chapel Hill, Department of Psychiatry

Locations

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, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22581236 (View on PubMed)

Other Identifiers

13-2995

Identifier Type: -

Identifier Source: org_study_id