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NCT00757497 · ClinicalTrials.gov registry record · Phase 1
Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia
A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Terminated
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00757497 is a Phase 1 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 20 participants.
The verdict
NCT00757497, a Phase 1 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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 do
Interventions
- BEHAVIORAL Electrical Polarization
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-09-17 |
| Est. Completion | 2015-08-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00757497
The ClinicalTrials.gov registry entry for NCT00757497 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Electrical Polarization is the first listed.
NCT00757497 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00757497 about?
NCT00757497 is a clinical study titled "Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia". 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...
What is the current status of trial NCT00757497?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2008-09-17. Estimated completion is 2015-08-18.
What interventions are being tested in trial NCT00757497?
The interventions under investigation include: Electrical Polarization (BEHAVIORAL).
Who is sponsoring clinical trial NCT00757497?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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