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Transcranial Direct Current Stimulation (TDCS) for Auditory Hallucinations in Early Onset Schizophrenia (EOS)

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ClinicalTrials.gov Identifier: NCT02764164
Recruitment Status : Terminated (Lack of funding)
First Posted : May 6, 2016
Results First Posted : October 20, 2020
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE August 3, 2015
First Posted Date  ICMJE May 6, 2016
Results First Submitted Date  ICMJE August 28, 2020
Results First Posted Date  ICMJE October 20, 2020
Last Update Posted Date March 5, 2021
Study Start Date  ICMJE January 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
Change in Severity of Auditory Hallucinations Measured by Auditory Hallucinations Rating Scale [ Time Frame: 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 ]
The primary efficacy assessment is the mean change from baseline to the last observed post-baseline visit in total score on the Auditory Hallucination Rating Scale (AHRS). Minimum score is 2, maximum score is 41, higher score indicates more severe symptoms.
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
Change in Severity of auditory hallucinations measured by Auditory Hallucinations Rating Scale [ Time Frame: Baseline to last observation: at baseline, following 5 days of TDCS, and at 1, 3, and 6 months expected average of every 3 months for up to 12 months ]
The primary efficacy assessment is the mean change from baseline to the last observed post-baseline visit, expected average of every 3 months (with last observation carried forward) in total score on the Auditory Hallucination Rating Scale (AHRS).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • Change in Schizophrenia Symptom Type as Measured by the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 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 ]
    The primary secondary outcome measure will be the change in severity of other symptoms of schizophrenia, assessed using the Positive and Negative Syndrome Scale (PANSS) from baseline to last observation, expected average of every 3 months. The PANSS can be computed as a dimensional scale including positive, negative, depression, disorganization, and grandiosity/excitement. Both the positive and negative scales have minimum scores of 7 and maximum scores of 49. The general scale has a minimum score of 16 and a maximum score of 112. Total score minimum is 30 and total score maximum is 210. Higher scores indicate more severe symptoms.
  • Change in Disorder Severity as Measured by Clinical Global Impressions Severity Scales (CGI-S) [ Time Frame: 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 ]
    Mean change from baseline to the last observed post-baseline visit Clinical Global Impression (CGI-S) severity scales. The minimum score on the CGI-S is 1 and the maximum score is 7. A higher score indicates more severe illness.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
  • Change in Schizophrenia symptom type as measured by the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline to last observation: at baseline, following 5 days of TDCS, and at 1, 3, and 6 months, expected average of 3 months for us to 12 months ]
    The primary secondary outcome measure will be the change in severity of other symptoms of schizophrenia, assessed using the Positive and Negative Syndrome Scale (PANSS) from baseline to last observation, expected average of every 3 months. The PANSS can be computed as a dimensional scale including positive, negative, depression, disorganization, and grandiosity/excitement.
  • Disorder severity as measured by Clinical Global Impressions improvement and severity scales (CGI) [ Time Frame: Baseline to last observation: at baseline, following 5 days of TDCS, and at 1, 3, and 6 months, expected average of 3 months for up to 12 months ]
    Clinical Global Impression (CGI) severity scales at each time point.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: May 4, 2016)
Change in Quality of life as measured by the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQLESQ) [ Time Frame: Baseline to last observation: At baseline, following 5 days of TDCS, and at 1, 3, and 6 monthsExpected average of every 3 months for up to 12 months ]
As an exploratory measure, quality of life will be assessed using the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQLESQ) will be conducted at baseline, following 5 days of TDCS, and at 1, 3, and 6 months
 
Descriptive Information
Brief Title  ICMJE Transcranial Direct Current Stimulation (TDCS) for Auditory Hallucinations in Early Onset Schizophrenia (EOS)
Official Title  ICMJE Transcranial Direct Current Stimulation for Auditory Hallucinations in Early Onset Schizophrenia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Device: Intervention Active tDCS
Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered directly to the brain area of interest via small electrodes. Placed over the temporoparietal junction to suppress auditory hallucinations.
Other Name: tdcs
Study Arms  ICMJE Experimental: Intervention Active tDCS
Affected subjects receiving up to 2 milliamps (mA) active tDCS, open label
Intervention: Device: Intervention Active tDCS
Publications * 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. Erratum in: Am J Psychiatry. 2012 Dec 1;169(12):1321.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 2, 2016)
1
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2016)
30
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02764164
Other Study ID Numbers  ICMJE 2014-6134
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ernest Pedapati Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP