Clinical trial NCT02764164: Transcranial Direct Current Stimulation (TDCS) for Auditory Hallucinations in Early Onset Schizophrenia (EOS)
Official title: Transcranial Direct Current Stimulation for Auditory Hallucinations in Early Onset Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: TDCS
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 1
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Youths diagnosed with early onset schizophrenia will demonstrate amelioration of auditory hallucinations after one week of twice daily treatment with transcranial direct current stimulation (tDCS).

Detailed description: Background: Early onset schizophrenia (EOS) involves positives symptoms such as psychotic behaviors, as well as negative symptoms such as disruptions to normal emotions and behaviors. Antipsychotics are the primary method of treatment in pediatric populations, but can produce unpleasant or dangerous side effects. Medication response is highly variable. Recent evidence demonstrates transcranial Direct Current Stimulation (tDCS) relieving auditory hallucinations (AH) associated with schizophrenia in adults, and to a lesser degree negative and cognitive symptomology. Such studies provide important scientific and technical knowledge that may be applied to pediatric populations.

Hypothesis: 1. Primary: Youths with EOS will demonstrate amelioration of AH after administration of tDCS. 2. TDCS will be well-tolerated in pediatric populations with minimal adverse side effects.

Eligibility criteria: Inclusion Criteria:

* Structured Clinical Interview for Diagnostic and Statistical Manual (DSM) Disorders (SCID) primary diagnosis of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-Version IV) schizophrenia or schizoaffective disorder
* Ages 8 to 25 years-old
* Persistent auditory hallucinations
* Full Scale intelligent quotient (IQ) greater than 60.
* Stable antipsychotic medication for \> 4 weeks
* If female and not infertile patient must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment or an interuterine device (IUD).
* Legal guardian has provided written informed consent and the subject has provided written informed assent when able. Expectation that a majority of subjects will be able to assent but the potential for the younger children and/or those that are of borderline intellectual functioning will not be able to assent.

Exclusion Criteria:

* History of alcohol, substance dependence or abuse in the past 90 days
* Open skin wounds that would preclude use of TDCS electrodes
* If female, pregnancy or breast feeding, as determined during eligibility pre-screen call
* Subjects exhibiting significant ongoing severe disruptive, aggressive, self-injurious, or sexually inappropriate behavior will not be eligible for enrollment.
* Presence of any medical condition that would make treatment with tDCS less safe. This includes any implanted metal device or any cardiac pacemaker. Subjects with a history of a seizure disorder are permitted if the subject has been seizure free for 6 months and is currently treated with an anticonvulsant that has been stable for 4 weeks.
* Presence of any other condition that would make the participants unable to comply with the requirements of the study for any reason. This may include an appreciable hearing or visual impairment.

Primary outcomes:
measure: Change in Severity of Auditory Hallucinations Measured by Auditory Hallucinations Rating Scale
timeFrame: Baseline to last observation: at baseline, following 5 days of TDCS, pre-specified every 3 months for up to 12 months, 2 week time point achieved
Secondary outcomes:
measure: Change in Schizophrenia Symptom Type as Measured by the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline to last observation: at baseline, following 5 days of TDCS, and pre-specified 1, 3, and 6 months, expected average of 3 months for us to 12 months, post-TDCS timepoint achieved
measure: Change in Disorder Severity as Measured by Clinical Global Impressions Severity Scales (CGI-S)
timeFrame: Baseline to last observation: at baseline, following 5 days of TDCS, pre-specified at 1, 3, and 6 months, expected average of 3 months for up to 12 months, post-TDCS time point achieved
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Ernest Pedapati
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.