Childhood Onset Psychotic Disorders | Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia
Childhood Onset Psychotic Disorders research study
What is the primary objective of this study?
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.
Who is eligible to participate?
- INCLUSION CRITERIA: 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: 1. Cognitive difficulties as evidenced by information from parents and teachers, clinical interview, and performance (below average based on published norms for each test) on neurocognitive tests (WMS-III Spatial Span (nonverbal) and WMS-III Letter-Number Sequencing (verbal) attention/vigilance (CPT-IP), and verbal learning (HVLT-R), all sub tests of the NIMH MATRICS battery). 2. Significant auditory hallucinations as measured by SAPS (scores above 2) or BPRS (scores above 3). EXCLUSION CRITERIA: In addition to the exclusion criteria under protocol 03-M-0035, the following will be exclusionary: 1. Broken or abnormal skin in the area of the electrodes. 2. Presence of metal in the cranial cavity. 3. Holes in the skull from trauma or surgery. 4. Positive pregnancy test. 5. Presence of other psychiatric illness (e.g. severe anxiety, OCD etc) unless the patient has been on stable medication for the prior 2 months
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Childhood Onset Psychotic Disorders
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: September 17, 2008
Completed Date: August 18, 2015
Phase: Phase 1
Primary Outcome: TDCS treatment is safe in childhood onset schizophrenia
Secondary Outcome: Improvement in cognition and psychosis
Study sponsors, principal investigator, and references
Principal Investigator: Nitin Gogtay, M.D.
Lead Sponsor: National Institute of Mental Health (NIMH)
Asarnow JR, Ben-Meir S. Children with schizophrenia spectrum and depressive disorders: a comparative study of premorbid adjustment, onset pattern and severity of impairment. J Child Psychol Psychiatry. 1988 Jul;29(4):477-88.