NCT02227563TerminatedNot Applicable
tDCS & Auditory Hallucinations in Schizophrenia (AVH-SZ)
Herzog Hospital2 sites in 1 country3 target enrollmentStarted: March 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- change from baseline in auditory hallucination rating scale
Study Overview
Brief Summary
The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral prefrontal cortex.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ages 18-60
- •Primary diagnosis of Diagnostic and Statistical Manual, fifth edition, schizophrenia
- •Persistent auditory verbal hallucinations
- •Right handed
- •Under stable doses of antipsychotic medication for ≥4 weeks
- •Normal hearing by self-report and physical exam
- •Use of effective method of birth control for women of childbearing capacity
- •Capable to provide informed consent. For patients judged to be incapable to provide informed consent the legal guardian of the patient must agree to participation in the study and provide signed informed consent
Exclusion Criteria
- •Current or past history of substance dependence or abuse (excluding nicotine)
- •Other current Axis I disorders
- •History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- •Frequent and persistent migraines
- •History of adverse reaction to neurostimulation
- •Participation in study of investigational medication within 6 weeks
- •Pregnancy
- •Women who are breast-feeding
- •Current significant laboratory abnormality
Outcomes
Primary Outcomes
change from baseline in auditory hallucination rating scale
Time Frame: 1 week post-treatment
Secondary Outcomes
- change in self-report quality of life scale from baseline(1 week post treatment)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
TDCS for Auditory Hallucinations in SchizophreniaSchizophreniaNCT01898299New York State Psychiatric Institute89
Completed
Not Applicable
Remediation of Auditory Recognition in Schizophrenia With tDCSSchizophreniaSchizoaffective DisorderNCT02869334New York State Psychiatric Institute20
Terminated
Not Applicable
Transcranial Direct Current Stimulation (TDCS) for Auditory Hallucinations in Early Onset Schizophrenia (EOS)SchizophreniaNCT02764164Children's Hospital Medical Center, Cincinnati1
Completed
Phase 3
Schizophrenia TreAtment With electRic Transcranial StimulationSchizophreniaNCT02535676University of Sao Paulo100
Recruiting
Not Applicable
Effects of Brain Stimulation on Cognition, Oscillations and GABA Levels in SchizophreniaSchizophreniaNCT04267003University of California, Davis160