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临床试验/NCT00757497
NCT00757497终止1 期

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

National Institute of Mental Health (NIMH)2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年9月17日最近更新:
适应症

试验速览

阶段
1 期
状态
终止
入组人数
20
试验地点
2
主要终点
TDCS treatment is safe in childhood onset schizophrenia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

TDCS treatment is safe in childhood onset schizophrenia

次要结局

  • Improvement in cognition and psychosis

研究者

研究点 (2)

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