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NCT00376506 · ClinicalTrials.gov registry record · Phase 2
A Comparison of an Implanted Neuroprosthesis With Sensory Training for Improving Airway Protection in Chronic Dysphagia
A Phase 2 study of Multiple Sclerosis and Parkinson Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT00376506 is a Phase 2 study of Multiple Sclerosis and Parkinson Disease that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 10 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00376506, a Phase 2 study of Multiple Sclerosis and Parkinson Disease, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will compare an implant with the technique of sensory training to determine which method may improve the ability to swallow and reduce the risk of choking. Many people with a brain injury or neurological disorders experience difficulty in swallowing. Past studies have shown that an electrical pulse applied to muscles or an increase in sensory stimulation to the throat can help. Patients ages 18 to 90 who have had a brain injury or neurological disorder and who have had trouble swallowing for 6 months or longer may be eligible for this study. Patients will undergo a physical examination, pregnancy test, and exam by a throat and speech physician. Fiber-optic endoscopic evaluation of swallowing with sensory testing involves a flexible tube passed through the nose to the back of the throat to allow observation of the voice box. Videofluoroscopy, an X-ray of the head and neck, will be done while patients swallow. Patients experiencing trouble with the upper esophagus may undergo additional procedures, including manometry to measure pressure changes in the back of the throat, and reevaluation through the fiber-optic tube. Patients in this study will have a magnetic resonance imaging (MRI) scan, which uses a strong magnetic field to obtain images of the body. Patients will lie on a table that slides into the enclosed tunnel of the scanner. The scan will take 20 to 25 minutes. Patients will be assigned randomly to one of two groups: the intramuscular group, to have a stimulation device implanted in the neck, and the vibrotactile group, to receive a vibrotactile stimulator. All patients will have 10 training sessions with their devices, plus follow-up. Those patients in the first group will undergo surgery, under general anesthesia, for the implant. Three weeks following the implant procedure, patients will come to NIH to have the stimulator turned on and programmed and to learn how to use the device. Those patients in the second group will have about 2 to 3 wee
Conditions Studied
Interventions
- DEVICE Neurostimulation device for dysphagia
- DEVICE External vibrotactile device
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2006-07 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00376506
The ClinicalTrials.gov registry entry for NCT00376506 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (98% lower). 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 3 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Neurostimulation device for dysphagia is the first listed.
NCT00376506 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00376506 about?
NCT00376506 is a clinical study titled "A Comparison of an Implanted Neuroprosthesis With Sensory Training for Improving Airway Protection in Chronic Dysphagia". This study will compare an implant with the technique of sensory training to determine which method may improve the ability to swallow and reduce the risk of choking. Many people with a brain injury or neurological disorders experience difficulty in swallowing. Past studies have shown that an electr...
What is the current status of trial NCT00376506?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2006-07. Estimated completion is 2011-01.
What conditions does trial NCT00376506 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Parkinson Disease, Chronic Dysphagia.
What interventions are being tested in trial NCT00376506?
The interventions under investigation include: Neurostimulation device for dysphagia (DEVICE), External vibrotactile device (DEVICE).
Who is sponsoring clinical trial NCT00376506?
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 NCT00376506 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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