N/A
Completed N=25
Targeting Auditory Hallucinations With Alternating Current Stimulation
Schizophrenia · Schizo Affective Disorder
Source: ClinicalTrials.gov NCT03221270 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Mean Auditory Hallucination Rating Scale (AHRS) Score — 25.00; 23.17; 23.40; 19.00 score on a scale — p=0.66
Summary
Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) as a treatment for auditory hallucinations in patients with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Auditory Hallucination Rating Scale (AHRS) Score |
25.00; 23.17; 23.40; 19.00; 25.13; 21.00 | 0.66 |
| SECONDARY Percentage of Signal Change in the Average Alpha Oscillation Power From Eyes-Open Resting State Electroencephalogram (EEG) |
1.64; 4.48; -11.64; 18.62; 31.35; 4.40 | — |
| SECONDARY Average Score on the Positive and Negative Syndrome Scales (PANSS) |
19.5; 16.8; 18.0; 19.0; 16.1; 18.2 | — |
| SECONDARY Brief Assessment Cognition in Schizophrenia (BACS) |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT03221270). 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. Informational only — not medical advice.