Phase 2
N=10
A Comparison of an Implanted Neuroprosthesis With Sensory Training for Improving Airway Protection in Chronic Dysphagia
Chronic Dysphagia · Multiple Sclerosis · Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT00376506 ↗Enrolled (actual)
10
Serious AEs
60.0%
Results posted
Oct 2012
Primary outcome: Primary: Swallowing Safety for 10 ml of Thin Liquid — 8.417; 7.167; 8.250; 7.375 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Neurostimulation device for dysphagia (Device); External vibrotactile device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Swallowing Safety for 10 ml of Thin Liquid |
8.417; 7.167; 8.250; 7.375 | — |
| PRIMARY Swallowing Safety for 5 ml of Pudding |
6.667; 6.917; 6.667; 6.583 | — |
| SECONDARY Penetration-Aspiration Scale for 10 ml Thin Liquid |
5.792; 5.000; 5.792; 4.292 | — |
| SECONDARY Penetration-Aspiration Scale for 5 ml Pudding |
1.417; 2.083; 2.333; 1.458 | — |
| SECONDARY Functional Oral Intake Scale (FOIS) for Dysphagia |
1.0; 1.0; 3.250; 3.0 | — |
| SECONDARY Quality of Life Patient Questionnaire |
55.208; 51.389; 68.316; 57.726 | — |
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 weeks of training in using a vibrotactile device, and then they will take it home to use. All patients 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.
...
Eligibility Criteria
- INCLUSION CRITERIA:
- Inclusive ages of 18 to 90.
- History of cerebral vascular accident (CVA), brain injury or chronic neurological disease such as Parkinson disease or multiple sclerosis or history of chemoradiation for treatment of head and neck cancer resulting in chronic dysphagia.
- Evidence of pharyngeal phase dysphagia that places the patient at risk for aspiration. Risk for aspiration or frank aspiration will be based on the medical history and evidence from a swallowing study. Absence of aspiration is not cause for exclusion if the risk for aspiration is deemed present due to impaired pharyngeal phase of swallowing as judged by an expert experienced in the evaluation of dysphagia. The patient may demonstrate evidence of aspiration or the risk for aspiration on any consistency, perhaps secondary to pharyngeal retention. Aspiration is defined as passage of food, liquid, or secretions into the trachea below the level of the vocal folds. Impaired pharyngeal phase of swallowing may be evidenced by pharyngeal delay, reduced hyolaryngeal elevation, reduced laryngeal closure, and reduced pharyngeal clearance of the bolus. Signs of pharyngeal delay include temporary pooling of the material in the vallecula with eventual spill over into the pyriform sinuses. Reduced hyolaryngeal elevation will be identified when the larynx is not protected by epiglottal lowering and remains opens to the bolus during a swallow on videoendoscopy. Reduced pharyngeal clearance can be seen during videoendoscopy when the bolus remains in the vallecula and/or pyriform sinuses.
- Other criteria for inclusion for subjects who do not meet the criteria of having aspiration on videofluoroscopy because of the limited number of swallows necessitated by radiation exposure, or who are noncompliant with their NPO status are:
- Not all of the bolus can enter the esophagus because of reduced opening of the upper esophageal sphincter, as a result there is pooling of the bolus in the pyriform sinuses which will spill over into the airway.
- Many patients who have had dysphagia for several years, have learned to cough up the bolus from the hypopharynx and spit it out, thus preventing aspiration but are continuing to be unable to ingest food or liquid. This is how they manage their accumulation of saliva by spitting in a cup throughout the day. In this way although they cannot swallow they do not aspirate on examination; rather they clear back up any remaining bolus up into their mouths.
- Other signs of risk of aspiration are the observation of liquid or food remaining in the pyriform sinuses, a wet gurgling sound during phonation indicating that there is pooling at the vocal folds and coughing when the bolus has already entered the trachea on attempts to swallow.
- Duration of Dysphagia for 6 months or more.
- A score of 2 or greater on the NIH Swallowing Safety Scale.
- Participants may have other health problems such as diabetes mellitus, arteriosclerotic coronary vascular disease and a history of smoking. These will not be cause for automatic exclusion, but will be examined on an individual basis by the otolaryngologist in determining the potential risk and benefit to the individual participant.
- Prior history of tracheostomy is not a cause for exclusion. Patients currently with a tracheostomy will be excluded.
- Restricted oral intake. Patients should demonstrate a current dependence on alternate means of nutrition and hydration (PEG, PEJ); however, PO intake is not cause for exclusion.
- Adequate cognitive skills as demonstrated by a Mini-Mental State Examination (MMSE) score greater than or equal to 23.
- Stable medical status. To determine if a patient has stable medical status prior to admission, the patient will be asked to provide a letter from their physician stating that the patient is medically stable and may participate in the study.
EXCLUSION CRITERIA
- Subjects with Severe or Very Severe Chronic Obstructive Pulmonary Disorder (COPD). Def
Data sourced from ClinicalTrials.gov (NCT00376506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.