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NCT00344877 · ClinicalTrials.gov registry record
Electrical Brain Stimulation to Reduce Epileptic Seizures
A clinical trial of Temporal Lobe Epilepsy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 56
- Enrollment target
- 1
- Study location
NCT00344877: Completed study of Temporal Lobe Epilepsy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT00344877 is a study of Temporal Lobe Epilepsy that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 56 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00344877, a study of Temporal Lobe Epilepsy, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
OBJECTIVES: About 15% of patients suffering from focal epilepsy are refractory to available pharmacological treatments. Until now, the only hope for such patients has been the development of new pharmaceutical treatments or epilepsy surgery. In case of inoperability, different types of invasive brain stimulation such as vagus nerve stimulation or deep brain stimulation or non-invasive repetitive TMS have been evaluated to determine their anticonvulsive potential. For rTMS, weak and short lasting seizure reduction has been reported in different epilepsy syndromes. A new, non-invasive stimulation technique, transcranial direct current stimulation (tDCS), was useful to modulate cortical excitability in many cortical areas (M1, visual cortex, frontal cortex). Cathodal tDCS, with a current of 1 mA, induced long-term depression in animal models and reportedly decreased the excitability of both human and animal cerebral cortex. In epilepsy patients suffering from a malformation of cortical development, a single session of cathodal tDCS helped reduce seizures briefly. The purpose of this protocol is to study the effects of repeated applications of tDCS on the excitability of the seizure focus in patients with poorly controlled pharmacologically refractory temporal lobe epilepsy. STUDY POPULATION: We plan to study 56 patients between the ages of 18 and 80 suffering from temporal lobe epilepsy. DESIGN: Subjects will be allocated by blocked randomization to one of two groups (parallel design). Group A will receive cathodal tDCS and group B will receive Sham-tDCS on five consecutive days. Each subject will participate in 9 sessions (1 baseline visit, 5 intervention visits, 3 follow-up visits). The effect of the intervention relative to the sham stimulation will be evaluated by comparing seizure frequency and neuropsychological tests during the 8 weeks before and after the intervention. OUTCOME MEASURES: Primary outcome measure will be the mean seizure frequency per 4 we
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2006-06-19 |
| Est. Completion | 2009-05-05 |
What the finished NCT00344877 record still lists
NCT00344877 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 56 participants, a relatively small participant target.
The record links to 1 condition, with Temporal Lobe Epilepsy appearing as the primary indexed condition, and to 0 interventions.
NCT00344877 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00344877 about?
NCT00344877 is a clinical study titled "Electrical Brain Stimulation to Reduce Epileptic Seizures". OBJECTIVES: About 15% of patients suffering from focal epilepsy are refractory to available pharmacological treatments. Until now, the only hope for such patients has been the development of new pharmaceutical treatments or epilepsy surgery. In case of inoperability, different types of invasive bra...
What is the current status of trial NCT00344877?
This trial is currently completed. The enrollment target is 56 participants. The study started on 2006-06-19. Estimated completion is 2009-05-05.
What conditions does trial NCT00344877 study?
This clinical trial studies the following conditions: Temporal Lobe Epilepsy.
Who is sponsoring clinical trial NCT00344877?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00344877 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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