N/A
N=25
STimulation to Improve Auditory haLLucinations
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02360228 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Proportional Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Score — 0.85; 0.94; 0.91; 0.84 proportion to baseline — p=0.47
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tACS (alpha) (Device); tDCS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportional Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Score |
0.85; 0.94; 0.91; 0.84; 0.94; 0.92 | 0.47 |
| SECONDARY Change in Alpha Oscillations Measured With Electroencephalogram (EEG) Resting State From Baseline |
1.5; 0.3; 0.4 | — |
| SECONDARY Change in Positive and Negative Syndrome Scale (PANSS) Scores |
51.25; 54.71; 55.29; 51.13; 52.86; 51.57 | 0.37 |
| SECONDARY Change in Brief Assessment of Cognition in Schizophrenia (BACS) Score |
31.58; 42.05; 41.50; 29.81; 39.71; 40.83 | 0.11 |
| SECONDARY Change in Peak Frequency of Functional Connectivity From Baseline Measured With Electroencephalogram (EEG) Resting State |
10; 8; 11 | — |
Summary
Investigating the effects of non-invasive transcranial current stimulation as a treatment for auditory hallucinations in patients with schizophrenia.
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
Data sourced from ClinicalTrials.gov (NCT02360228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.