STimulation to Improve Auditory haLLucinations

Not Applicable

Completed

Conditions: Schizoaffective Disorder
Schizophrenia

Interventions: Device: tACS (alpha)
Device: tDCS

Registration Number: NCT02360228

Lead Sponsor: University of North Carolina, Chapel Hill

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tACS (alpha)	tACS (alpha)	20 participants: 10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily
tDCS	tDCS	20 participants: 2mA stimulation for 20 minutes twice daily
Sham stimulation	tACS (alpha)	20 participants: Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.

Primary Outcome Measures

Name	Time	Method
Proportional Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Score	Baseline, five days post baseline, 2 weeks post baseline, 5 weeks post baseline	The Auditory Hallucination Rating Scale (AHRS) measures the severity of auditory hallucinations in the past week. The scale assesses frequency, duration, location, loudness, belief of origin of voices, negative content, distress, disruption to life, and control over voices. All items are measured on a scale of 0 to 4, with a total possible score of 44. Higher scores indicate higher severity of auditory hallucinations. The investigators will compare the AHRS scores from immediately before the first stimulation and immediately after the last stimulation session as the investigator's primary outcomes measure.

Secondary Outcome Measures

Name	Time	Method
Change in Alpha Oscillations Measured With Electroencephalogram (EEG) Resting State From Baseline	Baseline, five days post baseline	The investigators will compare alpha oscillation power from resting state EEG recordings on the first and last day of stimulation. The investigators will also collect EEG recordings data at the one week and one month follow up visits. The investigators will use each of the four EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers.
Change in Positive and Negative Syndrome Scale (PANSS) Scores	baseline, five days post baseline, five weeks post baseline	The investigators will compare the PANSS total scores immediately before first stimulation session and immediately after last stimulation session as secondary outcome measures. Scores range from 30 to 210, with higher scores indicating more severe symptomology.
Change in Peak Frequency of Functional Connectivity From Baseline Measured With Electroencephalogram (EEG) Resting State	Baseline, five days post baseline	The investigators will compare peak frequency of functional connectivity from resting state EEG recordings on the first and last day of stimulation. The investigators will also collect EEG recordings data at the one week and one month follow up visits. The investigators will use each of the four EEG recordings as data to analyze the change in peak frequency of functional connectivity as a pilot study for derivation of EEG biomarkers.
Change in Brief Assessment of Cognition in Schizophrenia (BACS) Score	baseline, five days post baseline, five weeks post baseline	The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery of cognitive assessments assessing verbal memory and learning, working memory, motor function, verbal fluency, speed of processing, and executive function. Higher scores indicate better cognitive performance. The investigators will compare the BACS total scores immediately before first stimulation session and immediately after last stimulation session as secondary outcome measures. Verbal Memory: Score out of 75 Digit Sequencing: Score out of 28 Token Motor: Score out of 100 Fluency: No score limit Symbol Coding: Score out of 110 Tower of London: Score out of 22 Reported score is the mean of these 6 subtests. Healthy controls (Keefe et al., 2006) scored 45.6 as a comparison.