Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00007124 · ClinicalTrials.gov registry record
Ketogenic Diet in Lafora Disease
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 15
- Enrollment target
NCT00007124 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 15 participants.
The verdict
NCT00007124 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study Summary
This study will examine the effect of a restricted-carbohydrate diet (ketogenic diet) on Lafora disease-a severe neurological disease in which brain cells die because of abnormal accumulation of glucose (a type of sugar). Patients with Lafora disease have rapid neurological deterioration with myoclonus (brief muscle jerks), seizures and mental decline. At present there is no treatment to halt disease progression. Patients 10 years of age and older with relatively advanced Lafora disease may be eligible for this study. Participants will be admitted to the Clinical Center for the first 4 weeks of this 6-month study for baseline testing and to start the ketogenic diet. They will have a complete medical history and physical examination, plus a detailed neurological examination and blood and urine tests. Procedures include: * Magnetic resonance imaging (MRI) brain scans to provide information about brain chemistry * Lumbar puncture (spinal tap) to analyze chemicals in cerebrospinal fluid * Metabolic and endocrinological tests, including a glucose tolerance test, to evaluate the body's response to a large intake of oral glucose * Standard neuropsychological tests * Magnetic resonance spectroscopy of the brain and muscle * Electroencephalography (EEG) to measure brain wave activity * Electromyography (EMG) to measure muscle activity * Evoked potentials (SEP and VEP) to study brain responses to mild electric or visual stimulation. Transcranial magnetic stimulation (magnetic stimulation of the brain) may also be done to study the function of the brain cortex (outer nervous tissue of the brain) and the effects of treatment on brain excitability. The ketogenic diet will begin after the tests are completed. The diet provides mainly fats to fuel the body, plus the recommended amount of protein and minimum carbohydrate. Vitamin and mineral supplements are provided to meet daily requirements. After 2 weeks on the diet, the patient will be discharged from the hospital and seen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2000-12 |
| Est. Completion | 2002-11 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00007124
The ClinicalTrials.gov registry entry for NCT00007124 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00007124 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00007124 about?
NCT00007124 is a clinical study titled "Ketogenic Diet in Lafora Disease". This study will examine the effect of a restricted-carbohydrate diet (ketogenic diet) on Lafora disease-a severe neurological disease in which brain cells die because of abnormal accumulation of glucose (a type of sugar). Patients with Lafora disease have rapid neurological deterioration with myoclo...
What is the current status of trial NCT00007124?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2000-12. Estimated completion is 2002-11.
Who is sponsoring clinical trial NCT00007124?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.