search
Back to results

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

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Active tDCS
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring TDCS

Eligibility Criteria

8 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Active tDCS

Arm Description

Affected subjects receiving up to 2 milliamps (mA) active tDCS, open label

Outcomes

Primary Outcome Measures

Change in Severity of Auditory Hallucinations Measured by Auditory Hallucinations Rating Scale
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.

Secondary Outcome Measures

Change in Schizophrenia Symptom Type as Measured by the Positive and Negative Syndrome Scale (PANSS)
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)
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.

Full Information

First Posted
August 3, 2015
Last Updated
February 8, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
search

1. Study Identification

Unique Protocol Identification Number
NCT02764164
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
TDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Active tDCS
Arm Type
Experimental
Arm Description
Affected subjects receiving up to 2 milliamps (mA) active tDCS, open label
Intervention Type
Device
Intervention Name(s)
Intervention Active tDCS
Other Intervention Name(s)
tdcs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Severity of Auditory Hallucinations Measured by Auditory Hallucinations Rating Scale
Description
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.
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
Secondary Outcome Measure Information:
Title
Change in Schizophrenia Symptom Type as Measured by the Positive and Negative Syndrome Scale (PANSS)
Description
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.
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
Title
Change in Disorder Severity as Measured by Clinical Global Impressions Severity Scales (CGI-S)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernest Pedapati
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22581236
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. Erratum In: Am J Psychiatry. 2012 Dec 1;169(12):1321.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs