N/A
N=27
Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia
Schizophrenia · Schizoaffective Disorder · Auditory Hallucinations
Bottom Line
View on ClinicalTrials.gov: NCT01963676 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5 — -6.38; -8.54 units on a scale — p=0.48
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tDCS (Device); Sham stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5 |
-6.38; -8.54 | 0.48 |
| SECONDARY Persistence of Decrease in AHRS Score Over Time |
-5.38; -4.77 | 0.86 |
Summary
Investigating the effect of non-invasive transcranial current stimulation on auditory hallucinations in patients with schizophrenia. Normal neuronal activity is perturbed in schizophrenia, so selective targeting of this abnormal activity could serve as a treatment for schizophrenia and alleviate symptoms caused by abnormal neuronal activity, such as auditory hallucinations.
Eligibility Criteria
Inclusion Criteria
- Diagnostic and Statistical Manual IV (DSM-IV) diagnosis of schizophrenia, any subtype, or schizoaffective disorder, with refractory auditory hallucinations. Duration of illness >1 year.
- 18-99 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 approximately 4 weeks or more.
- Capacity to understand all relevant risks and potential benefits of the study (informed consent) OR has a legal guardian who can complete consent forms on the patients behalf
- Right handed
Exclusion Criteria
- Subjects with a 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.
- History of significant head injury/trauma, as defined by loss of consciousness for more than 1 hour, or recurring seizures, or requiring later cognitive rehabilitation or causing cognitive sequelae.
- Prior brain surgery.
- Any brain devices/implants, including cochlear implants and aneurysm clips.
- Co-morbid neurological condition (i.e. seizure disorder, brain tumor).
- 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.
- Non English speakers.
- Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation
Data sourced from ClinicalTrials.gov (NCT01963676). 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.