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Official Study Title: A Comparison of an Implanted Neuroprosthesis With Sensory Training for Improving Airway Protection in Chronic Dysphagia
Sponsor: National Institute of Neurological Disorders and Stroke  National Institute of Neurological Disorders and Stroke (NINDS)A branch of the National Institutes of Health whose research concentrates on the brain and conditions that result in brain function irregularities. The NINDS funds much of the research on Parkinson's disease.  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. Internet address: http://www.ninds.nih.gov (NINDS)
Clinicaltrials.gov ID: NCT00376506
Study ID:

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. People 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. Participants 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 participants swallow. Participants experiencing trouble with the upper esophagus may undergo additional procedures, including a toxin injection, manometry-a test that measures pressure changes in the back of the throat, and reevaluation through the fiber-optic tube. Participants in this study will have a magnetic resonance imaging  Magnetic Resonance Imaging (MRI)A non-invasive technique that uses magnetism to create detailed pictures of the inside of the human body. (MRI) scan, which uses a strong magnetic field to obtain images of the body, and involves lying on a table that slides into the enclosed tunnel of the scanner. The scan takes 20 to 25 minutes. Participants will be assigned randomly to one of two groups: the intramuscular group, to have a stimulation device implanted in the neck, or the vibrotactile group, to receive a vibrotactile stimulator. Vibrotactile devices transmit sensory stimulation through physical contact with the skin. All participants will have 10 training sessions with their devices, plus follow-up. Participants in the first group will undergo surgery, under general anesthesia, for the implant. Three weeks following the implant procedure, participants will come to NIH to have the stimulator turned on and programmed and to learn how to use the device. Participants in the second group will have about 2 to 3 weeks of training in using a vibrotactile device, and then they will take it home to use. All participants will return to NIH at 3 months to ensure proper use of the devices, and they will visit for follow-up at 6 months and 12 months for tests and questionnaires.

Study Phase

Phase 2
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Swallowing difficulty

Time Commitment

• More than six months
• Approximately 1 ½ to 2 months of training, then check-in visits twice in six months, and one at a year.

Eligibility

• Minimum Age: 18
• Maximum Age: 90
• Gender(s) Accepted: Either

Inclusion Criteria

• History of a chronic neurological disease such as Parkinson's disease, or of a cerebral vascular event or brain injury.
• Evidence of dysphagia  DysphagiaDifficulty in swallowing. that places the patient at risk for aspiration. Aspiration refers to the accidental sucking in of food particles or fluids into the lungs.
• Duration of dysphagia for 6 months or more.
• Participants may have other health problems such as diabetes, coronary vascular disease and a history of smoking.
• Prior history of tracheostomy or current tracheostomy is not a cause for exclusion.
• Restricted oral intake. Participants should demonstrate a current dependence on alternate means of nutrition and hydration (PEG, PEJ); however, PO intake is not cause for exclusion.
• Adequate cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. skills as demonstrated by a Mini-Mental State Examination (MMSE) score greater than or equal to 23.
• Stable medical status.

Exclusion Criteria

• Chronic obstructive pulmonary disorder.
• HIV positive or immune compromised.
• Any persons with a pacemaker, deep brain stimulator or other indwelling electrical device.
• History of rapidly progressive neurodegenerative disorders, such as progressive supranuclear palsy,  Progressive Supranuclear Palsy, PSPA rare brain disorder diagnosed by the identification of early gait instability and difficulty moving the eyes. PSP is often misdiagnosed because some of its symptoms are very much like those of PD. Although PSP gets progressively worse and there is no effective treatment for it, the disease itself is not directly life-threatening. dementia,  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality. peripheral neuropathy, multiple systems atrophy or amyotrophic lateral sclerosis.
• Severe oral phase swallowing deficits, due to loss of tongue control.
• No aspiration or risk for aspiration in previous assessment or during preliminary studies.
• An esophageal motility disorder preventing food or liquid from adequately moving through the esophagus into the stomach.
• Pregnancy.
• Current psychiatric disorder other than depression.
• Inability to coordinate button press with swallow (as determined during screening)  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. .

Enrollment

Expected Enrollment: 60 (US)
Date Enrollment Began: Jul 01 2006
Last Updated Date: Feb 05 2007
Trial Post Date: Feb 05 2007
Website:

Primary Contacts and Locations

Maryland

• Recruitment and Public Liaison Office
  National Institutes of Health
  prpl@mail.cc.nih.gov
  Phone: 1-800-411-1222
  9000 Rockville Pike
  Bethesda, MD 20892
  USA