Clinical Trial: Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Safety of Transcranial Direct Current Brain Stimulation (TDCS) for Improvement of Psychotic Symptoms and Cognitive Functioning in Childhood Onset Schizophrenia (COS)

Brief Summary:

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 electroenc

    Detailed Summary:

    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
    Sponsor: National Institute of Mental Health (NIMH)

    Current Primary Outcome: TDCS treatment is safe in childhood onset schizophrenia

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Improvement in cognition and psychosis

    Original Secondary Outcome: Same as current

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: September 20, 2008
    Date Started: September 17, 2008
    Date Completion:
    Last Updated: April 19, 2017
    Last Verified: August 18, 2015