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

NCT00757497 | Terminated Phase 1

• 2 other identifiers: 08021108-M-0211
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Childhood Onset Psychotic Disorders; Schizophrenia; Psychosis; Mental Disorders

Keywords

Treatment Study; Psychosis; Electrical Stimulation; Refractory; Novel; Childhood Onset Psychotic Disorders; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• TDCS treatment is safe in childhood onset schizophrenia

Secondary Outcomes (1)

• Improvement in cognition and psychosis

Interventions

Electrical Polarization BEHAVIORAL

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).
• Significant auditory hallucinations as measured by SAPS (scores above 2) or BPRS (scores above 3).

You may not qualify if:

• Broken or abnormal skin in the area of the electrodes.
• Presence of metal in the cranial cavity.
• Holes in the skull from trauma or surgery.
• Positive pregnancy test.
• Presence of other psychiatric illness (e.g. severe anxiety, OCD etc) unless the patient has been on stable medication for the prior 2 months

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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. doi: 10.1111/j.1469-7610.1988.tb00738.x.

  PMID: 3215919 BACKGROUND

• Watkins JM, Asarnow RF, Tanguay PE. Symptom development in childhood onset schizophrenia. J Child Psychol Psychiatry. 1988 Nov;29(6):865-78. doi: 10.1111/j.1469-7610.1988.tb00759.x.

  PMID: 3235494 BACKGROUND

• Russell AT, Bott L, Sammons C. The phenomenology of schizophrenia occurring in childhood. J Am Acad Child Adolesc Psychiatry. 1989 May;28(3):399-407. doi: 10.1097/00004583-198905000-00017.

  PMID: 2738007 BACKGROUND

• Berman RA, Gotts SJ, McAdams HM, Greenstein D, Lalonde F, Clasen L, Watsky RE, Shora L, Ordonez AE, Raznahan A, Martin A, Gogtay N, Rapoport J. Disrupted sensorimotor and social-cognitive networks underlie symptoms in childhood-onset schizophrenia. Brain. 2016 Jan;139(Pt 1):276-91. doi: 10.1093/brain/awv306. Epub 2015 Oct 22.

  PMID: 26493637 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Nitin Gogtay, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 20, 2008
• First Posted: September 23, 2008
• Study Start: September 17, 2008
• Study Completion: August 18, 2015
• Last Updated: December 12, 2019

Record last verified: 2015-08-18

Locations

US (1)