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Schizophrenia | Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

Schizophrenia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Schizophrenia

Schizoaffective Disorder

Auditory Hallucinations

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:tDCS

Device:Sham stimulation

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

transcranial direct current stimulation (tDCS)13 subjects total. 2mA stimulation for 20 minutes.

Sham stimulation13 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.

Study Status

Completed

Start Date: January 2014

Completed Date: October 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5

Secondary Outcome: Persistence of Decrease in AHRS Score Over Time

Study sponsors, principal investigator, and references

Principal Investigator: Flavio Frohlich, PhD

Lead Sponsor: University of North Carolina, Chapel Hill

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01963676

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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