Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00757497|
Recruitment Status : Terminated
First Posted : September 23, 2008
Last Update Posted : June 26, 2018
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:
- Are 10 yrs or older age.
- Are participating in NIH protocol 03-M-0035.
- Are on a stable medication regimen for at least 6 months.
- Have problems with memory and attention span or have auditory hallucinations.
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:
- Checks of blood pressure, pulse and breathing rate before, during and right after each stimulation and again 8 hours later.
- Electrocardiogram (EKG) and electroencephalogram (EEG) before starting stimulation and after completing the 10 days of TDCS.
- Interviews and examinations to check for side effects of TDCS.
- Pen-and-paper or computer tests of learning, attention and memory.
- At the end of the 10 sessions, children who were in the sham TDCS group are offered the same number of sessions of active TDCS.
- Follow-up telephone call 1 month after the end of stimulation to see how the child is doing.
- 1- to 2-day outpatient visit 6 months after the stimulation. This visit includes interviews with the parent and the child, rating of the child s psychiatric symptoms, and pen-and-paper or computer tests of thinking, attention and memory.
|Condition or disease||Intervention/treatment||Phase|
|Childhood Onset Psychotic Disorders Schizophrenia Psychosis Mental Disorders||Behavioral: Electrical Polarization||Phase 1|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Safety of Transcranial Direct Current Brain Stimulation (TDCS) for Improvement of Psychotic Symptoms and Cognitive Functioning in Childhood Onset Schizophrenia (COS)|
|Study Start Date :||September 17, 2008|
|Actual Study Completion Date :||August 18, 2015|
- TDCS treatment is safe in childhood onset schizophrenia
- Improvement in cognition and psychosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757497
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Nitin Gogtay, M.D.||National Institute of Mental Health (NIMH)|