Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia
Clinical Trial to Assess Transcranial Current Stimulation as a Treatment for Medication Refractory Auditory Hallucinations in Schizophrenia
1 other identifier
interventional
26
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Jan 2014
Shorter than P25 for not_applicable schizophrenia
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2013
CompletedFirst Posted
Study publicly available on registry
October 16, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
February 22, 2016
CompletedFebruary 22, 2016
January 1, 2016
9 months
October 13, 2013
December 10, 2015
January 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5
Examining AHRS total score after 5 days of stimulation compared to baseline assessment total.
Baseline, Day 5
Secondary Outcomes (1)
Persistence of Decrease in AHRS Score Over Time
Day 5, One month
Study Arms (2)
transcranial direct current stimulation (tDCS)
EXPERIMENTAL13 subjects total. 2mA stimulation for 20 minutes.
Sham stimulation
SHAM COMPARATOR13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnostic and Statistical Manual IV (DSM-IV) diagnosis of schizophrenia, any subtype, or schizoaffective disorder, with refractory auditory hallucinations. Duration of illness \>1 year.
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of North Carolina at Chapel Hill, Outpatient STEP Clinic
Chapel Hill, North Carolina, 27599-7250, United States
University of North Carolina, Wake STEP Clinic
Raleigh, North Carolina, 27610, United States
Related Publications (1)
Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091.
PMID: 22581236BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Flavio Frohlich
- Organization
- UNC Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Flavio Frohlich, PhD
University of North Carolina at Chapel Hill, Department of Psychiatry
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Departments of Psychiatry, Cell Biology and Physiology, and Biomedical Engineering
Study Record Dates
First Submitted
October 13, 2013
First Posted
October 16, 2013
Study Start
January 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
February 22, 2016
Results First Posted
February 22, 2016
Record last verified: 2016-01