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NCT00306501 · ClinicalTrials.gov registry record · Phase 2
Volitional Swallowing in Stroke Patients With Chronic Dysphagia
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT00306501 is a Phase 2 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 34 participants.
The verdict
NCT00306501, a Phase 2 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
This study will compare several techniques designed to improve the ability to swallow in stroke patients with chronic dysphagia (difficulty swallowing). Healthy volunteers 20 to 60 years of age and people 20 to 90 years of age who have had a stroke resulting in swallowing problems may be eligible for this study. Volunteers are screened with a medical history, physical examination, and urine test for women to rule out pregnancy. Stroke patients are screened additionally with a chest x-ray, physical examination, cognitive screening, swallowing questionnaires, nasoendoscopy (examination of the nasal passages in the back of the throat using a lighted telescopic instrument) and FEESST (passage of a thin, flexible telescope through the nose to the voice box), videofluoroscopy (x-ray of the head and neck during swallowing) and button press training (learning how to press a button on a table in coordination with swallowing). All participants undergo the following procedures: * Transcranial magnetic stimulation (TMS): A metal coil is placed on the head and sends a pulse of energy to the brain through the scalp. The muscle response to the pulse is recorded from the muscles in the throat that are associated with swallowing. * Electromyography: A needle is used to insert tiny wires in specific muscles of the throat to record the muscle response to the TMS pulses. * Magnetic resonance imaging (MRI): During brain MRI scanning, subjects lie quietly and images of the brain are taken. In addition to the above tests, stroke patients undergo the following: * Water test: The subject swallows a small amount of water and the number of times required to clear the throat or cough is counted. This test is repeated five times. * Experimental training. Subjects have a total of 12 60-minute training sessions, one session a day for up to 5 sessions a week. * Button press training: The subject swallows small amounts of water. A device placed on the throat senses when swallowing occurs. T
Interventions
- PROCEDURE Swallowing Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2006-03-17 |
| Est. Completion | 2009-12-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00306501
The ClinicalTrials.gov registry entry for NCT00306501 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 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 1 intervention - of which Swallowing Training is the first listed.
NCT00306501 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00306501 about?
NCT00306501 is a clinical study titled "Volitional Swallowing in Stroke Patients With Chronic Dysphagia". This study will compare several techniques designed to improve the ability to swallow in stroke patients with chronic dysphagia (difficulty swallowing). Healthy volunteers 20 to 60 years of age and people 20 to 90 years of age who have had a stroke resulting in swallowing problems may be eligible f...
What is the current status of trial NCT00306501?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2006-03-17. Estimated completion is 2009-12-16.
What interventions are being tested in trial NCT00306501?
The interventions under investigation include: Swallowing Training (PROCEDURE).
Who is sponsoring clinical trial NCT00306501?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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