Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia
NCT ID: NCT00757497
Last Updated: 2019-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
20 participants
INTERVENTIONAL
2008-09-17
2015-08-18
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Interventions
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Electrical Polarization
Eligibility Criteria
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Inclusion Criteria
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
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
10 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Principal Investigators
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Nitin Gogtay, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Mental Health (NIMH)
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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08-M-0211
Identifier Type: -
Identifier Source: secondary_id
080211
Identifier Type: -
Identifier Source: org_study_id