Clinical trial NCT03221270: Targeting Auditory Hallucinations With Alternating Current Stimulation
Official title: Targeting Auditory Hallucinations With Alternating Current Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizo Affective Disorder
Keywords: tACS
Sham
Auditory Hallucinations
Schizophrenia
Schizo Affective Disorder
EEG
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-07-18
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: FACTORIAL
Intervention model description: Participants will initially be randomized to either sham or 10 Hz tACS for the 5 consecutive days of stimulation. Participants will then be re-randomized to either sham or 10 Hz tACS for the 8 weeks of maintenance stimulation.
Primary purpose: TREATMENT

Brief summary: Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) as a treatment for auditory hallucinations in patients with schizophrenia.

Detailed description: The investigator's primary objective is to provide further evidence for the effectiveness of transcranial alternating current stimulation (tACS) to treat auditory hallucinations and to collect preliminary data on whether maintenance stimulation sessions can prolong the duration of stimulation-induced clinical benefits. The investigators will be looking into effects of tACS to re-normalize pathological alpha oscillations in the dorso-lateral prefrontal cortex (dl-PFC) of patients with schizophrenia or schizo-affective disorder by comparing Auditory Hallucination Rating Scale (AHRS) scores immediately before the first stimulation session, immediately after the last stimulation session, and at the end of the 8 weeks of maintenance sessions. As a secondary objective, the investigators will assess the differential clinical effects of active sham and 10Hz tACS on electroencephalogram (EEG) measures of alpha oscillations. The investigators will also be using source localization techniques in EEG analysis, based on individual locations of the scalp electrodes and anatomical structures with the use of structural magnetic resonance imaging (sMRI).

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia, any subtype, or schizoaffective disorder with refractory hallucinations. Duration of illness \>1 year
* 18 - 70 years old
* Clinical stable for at least 12 weeks i.e. not requiring any hospitalization or a change in level of care
* On current antipsychotic doses for at least 4 weeks
* Experience at least 3 auditory hallucinations per week
* 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 the informed consent on the patient's behalf with the patient providing written assent to participate

Exclusion Criteria:

* 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
* Positive urine test of cannabis, cocaine, amphetamine, barbiturates, opiates
* Current treatment (within 4 weeks) with psychotropic agents including benzodiazepines that are taken on a daily basis (limit prn use to greater than 48 hours before participating in a study session)
* 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
* A difference of greater than 20% in AHRS scores between screening visits
* 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 appropriate birth control measures during study participation
* Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participants' full compliance with or completion of the study

Primary outcomes:
measure: Mean Auditory Hallucination Rating Scale (AHRS) Score
timeFrame: Baseline, immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation.
Secondary outcomes:
measure: Percentage of Signal Change in the Average Alpha Oscillation Power From Eyes-Open Resting State Electroencephalogram (EEG)
timeFrame: Change from baseline to immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation.
measure: Average Score on the Positive and Negative Syndrome Scales (PANSS)
timeFrame: Baseline, immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation.
measure: Brief Assessment Cognition in Schizophrenia (BACS)
timeFrame: Baseline, immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation.
Other outcomes:
measure: Electroencephalogram (EEG) Auditory Task
timeFrame: Change across time from baseline measurement to final maintenance stimulation
measure: Auditory Hallucination Rating Scale (AHRS)
timeFrame: Change from Baseline AHRS at final maintenance stimulation session.
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Change from Baseline PANSS at final maintenance stimulation session.
measure: Brief Assessment Cognition in Schizophrenia (BACS)
timeFrame: Change from Baseline BACS at final maintenance stimulation session.
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.
citation: Frohlich F, Burrello TN, Mellin JM, Cordle AL, Lustenberger CM, Gilmore JH, Jarskog LF. Exploratory study of once-daily transcranial direct current stimulation (tDCS) as a treatment for auditory hallucinations in schizophrenia. Eur Psychiatry. 2016 Mar;33:54-60. doi: 10.1016/j.eurpsy.2015.11.005. Epub 2016 Feb 8.