Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Schizophrenia, Schizoaffective Disorder, Auditory Hallucinations

Intervention / Treatment
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* Device: tDCS
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transcranial direct current stimulation (tDCS)<br>13 subjects total. 2mA stimulation for 20 minutes. | Device: tDCS<br> <br> |
| Sham Comparator: Sham stimulation<br>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. | Device: Sham stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, auditory hallucinations, transcranial stimulation, tDCS, tACS