Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia
|First Received Date ICMJE||September 20, 2008|
|Last Updated Date||December 11, 2014|
|Start Date ICMJE||September 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||TDCS treatment is safe in childhood onset schizophrenia|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00757497 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Improvement in cognition and psychosis|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia|
|Official Title ICMJE||Safety of Transcranial Direct Current Brain Stimulation (TDCS) for Improvement of Psychotic Symptoms and Cognitive Functioning in Childhood Onset Schizophrenia (COS)|
This study will test whether transcranial direct current stimulation (TDCS) can be used safely in children with schizophrenia and if it can improve memory and attention span or auditory hallucinations in these children, at least temporarily. TDCS has temporarily improved memory and attention span in healthy adults and a similar method called TMS has relieved auditory hallucinations in adults with schizophrenia. For the TDCS procedure, the child sits in a chair and two soft sponge electrodes are placed on the child s forehead and held in place with a soft wrapping. One sponge electrode is placed on an arm. The electrodes are attached to a stimulator with a wire.
Children with schizophrenia who meet the following criteria may be eligible for this study:
Participants are randomly assigned to receive either real or sham TDCS on an inpatient or outpatient basis in 20-minute sessions daily, except weekends, for 10 days. For real TDCS, patients receive stimulation to the front of the brain. For sham stimulation, the children have electrodes placed on the forehead, but no actual stimulation is delivered. In addition to TDCS, patients have the following procedures:
Background: The majority (about 75%) of patients with childhood onset schizophrenia still have impairing cognitive and psychotic symptoms after drug treatment optimization. Recent studies with transcranial magnetic stimulation (TMS) indicate moderate efficacy in symptom reduction in adult patients with schizophrenia. Transcranial direct current stimulation (TDCS) may be a safe and effective additional treatment of residual symptoms of schizophrenia in medication stable patients. Recent research into adult-onset schizophrenia established both safety and efficacy in 20-minute daily DC polarization (TDSC).
Objective: To establish whether bilateral DC polarization (using TDCS) of either dorsolateral prefrontal cortex or superior temporal cortex is safe in patients with childhood onset schizophrenia and whether it is associated with improvement in cognitive performance or reduction in auditory hallucination (psychotic symptoms) respectively.
Study population: Up to 40 patients with schizophrenia, ages 10 and older will be recruited. All patients will be on optimized medications for at least 2 months prior to this study.
Design: The design has two concurrent study options; both double-blind sham controlled, with 10-day, 40-minute daily DC polarization. Patients will be selected for one of the two treatment options: 1. Bilateral Anodal DC polarization of prefrontal cortex or 2. Bilateral Cathodal DC polarization of superior temporal cortex. A small battery powered device (Phoresor II Auto Model PM850) approved by the FDA for iontophoretic transdermal drug delivery will be used to administer the DC current. Sham treatment will be electrode placement without current.
Outcome Measures: The primary outcome measure would be to determine whether TDCS treatment is safe in children and adults with schizophrenia, as assessed by vital signs monitoring, reporting/evaluation of adverse effects, clinical ratings and neurocognitive performance.
Secondary outcome measures: The secondary outcome measures would be improvement on 1) Hallucination Change Scale (HCS) and Auditory Hallucinations Rating Scale (AHRS) for auditory hallucinations; SAPS, SANS and BPRS scales for psychotic symptoms and 2) performance on the working memory (verbal and non verbal), attention/vigilance, and verbal learning sub tests for cognitive improvement.
Exploratory Measure: Effect of DC polarization on regional GM cortical thickness in DLPFC and STG regions.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Behavioral: Electrical Polarization
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||40|
|Estimated Completion Date||May 2015|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
COS patients (age 10 and above) recruited and followed under the current protocol 03-M-0035, where subjects have been stable (in the judgment of the investigator) on their medications for 2 months with or without PRN medications but continue to experience either:
In addition to the exclusion criteria under protocol 03-M-0035, the following will be exclusionary:
|Ages||10 Years and older|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00757497|
|Other Study ID Numbers ICMJE||080211, 08-M-0211|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP