A Comparison of an Implanted Neuroprosthesis With Sensory Training for Improving Airway Protection in Chronic Dysphagia
Completed
Phase 2 ResultsSummary of Purpose
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...
Read More →Trial Milestones
The following dates are available for this trial. Trial information last updated on 25 September 2012.
1 Jul 2006 | 14 Sep 2006 | 1 Sep 2010 | 1 Jan 2011 | 1 Sep 2012 | 1 Nov 2011 |
Start Date | First Received | 1st Completion | Completion | Verification | Results |
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Trial Basics
Interventions
- Neurostimulation System for Dysphagia
- Neurostimulation device for dysphagia
- External vibrotactile device
Conditions
Sponsors
Trial Design
- Allocation: Randomized
- Masking: Single Blind
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Contacts
Not available
View Trial Locations
Recruitment
- Enrollment: 10
- Gender: Both
- Minimum Age: 18 Years
- Accepts Healthy Volunteers: No
- 1 location, 1 country
Principal Investigator
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Christy L. Ludlow, Ph.D.
Christy L. Ludlow, Ph.D., CCC-SPL, BC-ANCDS Professor, Department of Communication Sciences and Disorders, Director, Laboratory on Neural Bases of Communication and Swallowing, PhD Coordinator James Madison University HHS 1141, MSC 4304 Harrisonburg, VA 22807 Phone 540-568-3876 Fax 540-568-8077 email: ludlowcx@jmu.edu personal webpage: http://www.csd.jmu.edu/people/ludlow.html Lab webpage: http://www.csd.jmu.edu/labs/neuralbases.html