Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00757497 |
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:
Condition | Intervention | Phase |
---|---|---|
Childhood Onset Psychotic Disorders Schizophrenia Psychosis Mental Disorders Mental Disorder Diagnosed in Childhood |
Behavioral: Electrical Polarization |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Safety of Transcranial Direct Current Brain Stimulation (TDCS) for Improvement of Psychotic Symptoms and Cognitive Functioning in Childhood Onset Schizophrenia (COS) |
Estimated Enrollment: | 40 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
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.
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 6 months prior to this study.
Design: The design has two concurrent study options; each double blind sham controlled, with 10-day, 20-min 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 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.
Ages Eligible for Study: | 10 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
COS patients (age 10 and older) recruited and followed under the current protocol 03-M-0035, where subjects have been stable on their medications for 6 months but continue to experience either:
EXCLUSION CRITERIA:
In addition to the exclusion criteria under protocol 03-M-0035, the following will be exclusionary:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 080211, 08-M-0211 |
Study First Received: | September 20, 2008 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00757497 History of Changes |
Health Authority: | United States: Federal Government |
Treatment Study Psychosis Electrical Stimulation Refractory |
Novel Childhood Onset Psychotic Disorders Schizophrenia Psychosis |
Schizophrenia Mental Disorders Mental Disorders Diagnosed in Childhood |
Psychotic Disorders Childhood-Onset Schizophrenia Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Pathologic Processes Disease Mental Disorders |
Mental Disorders Diagnosed in Childhood Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |