Expired Study
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Chapel Hill, North Carolina 27599


Purpose:

Investigating the effects of non-invasive transcranial current stimulation as a treatment for auditory hallucinations in patients with schizophrenia.


Study summary:

The investigator's primary objective is to conduct a pilot clinical trial to establish the feasibility and to collect first effectiveness data for the use of transcranial alternating current stimulation (tACS) to re-normalize pathological alpha oscillations in dorso-lateral prefrontal cortex (dl-PFC) of patients with schizophrenia or schizoaffective disorder by comparing Auditory Hallucination Rating Scale (AHRS) scores immediately before the first stimulation session and immediately after the last stimulation session. As a secondary objective the investigators will assess the differential clinical effects of sham, 10 Hz and 2 mA transcranial direct current stimulation (tDCS) on electroencephalogram (EEG) measures of alpha oscillations.


Criteria:

Inclusion Criteria: - DSM-IV diagnosis of schizophrenia, any subtype, or schizoaffective disorder, with refractory auditory hallucinations. Duration of illness >1 year - 18-70 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 at least 4 weeks - Stable auditory hallucinations as demonstrated by having less than or equal to 20% change in AHRS scores across a 2 week interval during the screening period. - Capacity to understand all relevant risks and potential benefits of the study and to provide written informed consent, OR has a legal guardian who can provide informed consent on the patient's behalf with the patient providing written assent to participate. Exclusion Criteria: - DSM-IV diagnosis of alcohol of 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 - 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 - History of traumatic brain injury that required subsequent cognitive rehabilitation, or caused cognitive sequelae - Prior brain surgery - Any brain devices/implants, including cochlear implants and aneurysm clips - Co-morbid neurological condition (e.g. seizure disorder, brain tumor) - Non English speakers - Female participants who are pregnant, nursing, or unwilling to use an adequate method of contraception during study participation for those of childbearing potential - Positive urine test for cannabis, cocaine, amphetamine, barbiturates, benzodiazepines, opiates


NCT ID:

NCT02360228


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Chapel Hill, North Carolina 27599
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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