STimulation to Improve Auditory haLLucinations (STILL 2)

University of North Carolina (UNC)

Status: Completed

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Device: tDCS; Device: tACS (alpha)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02360228

14-3285

1R21MH105574-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 3 patient groups

tACS (alpha)

Experimental group

Description:

20 participants: 10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily

Treatment:

Device: tACS (alpha)

tDCS

Experimental group

Description:

20 participants: 2mA stimulation for 20 minutes twice daily

Treatment:

Device: tDCS

Sham stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: tACS (alpha)