Clinical trial NCT02360228: STimulation to Improve Auditory haLLucinations
Official title: Targeting Auditory Hallucinations With Alternating Current Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: tACS
tDCS
sham
auditory hallucinations
Schizophrenia
Schizoaffective Disorder
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-02-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Proportional Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Score
timeFrame: Baseline, five days post baseline, 2 weeks post baseline, 5 weeks post baseline
Secondary outcomes:
measure: Change in Alpha Oscillations Measured With Electroencephalogram (EEG) Resting State From Baseline
timeFrame: Baseline, five days post baseline
measure: Change in Positive and Negative Syndrome Scale (PANSS) Scores
timeFrame: baseline, five days post baseline, five weeks post baseline
measure: Change in Brief Assessment of Cognition in Schizophrenia (BACS) Score
timeFrame: baseline, five days post baseline, five weeks post baseline
measure: Change in Peak Frequency of Functional Connectivity From Baseline Measured With Electroencephalogram (EEG) Resting State
timeFrame: Baseline, five days post baseline
Other outcomes:
measure: Change in Electroencephalogram (EEG) Auditory Tasks: Oddball Task From Baseline
timeFrame: baseline, five days post baseline
measure: Change in Electroencephalogram (EEG) Auditory Tasks: Click Train Task From Baseline
timeFrame: baseline, five days post baseline
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina at Chapel Hill - Department of Psychiatry
name: Flavio Frohlich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.