CompletedNCT00376506Updated Oct 26, 2012Results posted

A Comparison of an Implanted Neuroprosthesis With Sensory Training for Improving Airway Protection in Chronic Dysphagia

A Phase 2 interventional study of Neurostimulation device for dysphagia and External vibrotactile device in Chronic Dysphagia, Multiple Sclerosis and Parkinson Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-10-26.

Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 10
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

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 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.

...

Read the detailed description

Objective: To determine if an implanted neuroprosthesis improves airway protection for swallowing in chronic pharyngeal dysphagia to a greater degree than sensory training. The implanted neuroprosthesis will provide intramuscular stimulation to as many as 8 hyo-laryngeal muscles. Stimulation will be coincident with a button press initiation under patient control while eating or at regular intervals for saliva swallows during the day and/or at night. Sensory training will include vibrotactile stimulation to the neck coincident with swallowing under patient control to assist with swallowing while eating or for saliva swallows during the day.

Study population: Persons with chronic (greater than 6 months) dysphagia with risk of aspiration secondary to neurological injury, stroke or chronic neurological disease who currently require enteric feeding or severe dietary restrictions because of risk of aspiration.

Design: A Phase 2 clinical trial with random assignment between two treatment groups with blinded assessment of treatment outcome. Both treatment groups will undergo 2 weeks of device training with a speech pathologist. The implant group will undergo training starting 3 weeks after implantation. They will receive prescriptive training when the levels of muscles stimulation will be established for swallowing. Patients will be trained to press a switch to control the stimulation while they are swallowing. The sensory training group will receive the same amount of training to provide sensory stimulation coincident with attempting to swallow.

Outcome measures: Blinded assessment of risk of aspiration on videofluoroscopy using the NIH Swallowing Safety Scale, and patient administration of the Functional Oral Intake Scale (FOIS) for Dysphagia and the Swallowing Quality of Life Outcomes Tool (SWAL_QOL) prior to treatment and at 3, 6, 9, and 12 months following treatment. Patient administration of the FOIS and SWAL_QOL at 24-months.

Conditions studied

Chronic Dysphagia
Multiple Sclerosis
Parkinson Disease

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Keywords

Aspiration
Rehabilitation
Swallowing Disorders
Stroke
Parkinson's Disease
Dysphagia
Parkinson Disease
PD

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 592 studies on the registry; 56 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

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:
1. 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.
2. 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.
3. 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

EXCLUSION CRITERIA:

Subjects with Severe or Very Severe Chronic Obstructive Pulmonary Disorder (COPD). Definition of Severe COPD is an FEV(1)/FVC ratio of less than 70% and an FEV(1) of 30 to less than 50% of predicted. The definition of Very severe COPD is an FEV(1)/FVC ratio of less than 70% and an FEV(1) of less than 30% of predicted. Spirometry will be performed according to the standards of the American Thoracic Society using reference values that include a correction for race.
HIV positive or immune compromised. This is essential because increased risk of immune reactions to the implantation of a foreign device in patients who are immune compromised. Such patients would be at much greater risk of an infection with implantation of a device. Participation would more likely lead to the need an explanation and a second surgery.
Patients with a pacemaker, deep brain stimulator or other indwelling electrical device.
History of rapidly progressive neurodegenerative disorders, such as progressive supranuclear palsy, dementia, peripheral neuropathy, multiple systems atrophy or amyotrophic lateral sclerosis.
Severe oral phase swallowing deficits, due to loss of tongue control, that prevent bolus retention in the oral cavity.
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.
Pregnant women will be excluded from participation because the study involves radiation exposure.
Current psychiatric disorder other than depression. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, schizophrenia or bipolar disorder.
Inability to coordinate button press with swallow (as determined during screening).

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single
Enrollment: 10 participants (actual)

Study arms

Experimental
Implanted Device
Implanted intramuscular neurostimulator device
Device: Neurostimulation device for dysphagia
Active comparator
External Device
External vibrotactile device
Device: External vibrotactile device

Interventions

DeviceNeurostimulation device for dysphagia
A neurostimulation device that is surgically implanted in the swallowing muscles.
DeviceExternal vibrotactile device
A vibrotactile device that is placed on the neck during swallowing.

What researchers measure

Primary outcomes

Swallowing Safety for 10 ml of Thin Liquid
Every 3 months swallowing safety was measured using the Swallowing Safety Scale (SSS). The SSS measures 11 swallowing variables including: the presence of residue in the valleculae, laryngeal vestibule, and/or pyriform sinuses, the presence of penetration arising from the oropharynx and/or the hypopharynx, the number of aspiration events arising from the oropharynx and/or the hypopharynx, response to aspiration, degree of esophageal entry, presence of regurgitation, and the presence of \>1 swallow per bolus. Scores range from 0 (safe swallowing) to \>5 (severely impaired swallowing safety). The maximum score is infinite as the number of occurrences of aspiration is counted in the total score. A higher score on the SSS indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The SSS was scored from videotaped swallows, by speech pathologists. The raters were blinded to the identity of the patient, group, and time post training.
Time frame: Baseline and 12-months post-treatment
Swallowing Safety for 5 ml of Pudding
Every 3 months swallowing safety was measured using the Swallowing Safety Scale (SSS). The SSS measures 11 swallowing variables including: the presence of residue in the valleculae, laryngeal vestibule, and/or pyriform sinuses, the presence of penetration arising from the oropharynx and/or the hypopharynx, the number of aspiration events arising from the oropharynx and/or the hypopharynx, response to aspiration, degree of esophageal entry, presence of regurgitation, and the presence of \>1 swallow per bolus. Scores range from 0 (safe swallowing) to \>5 (severely impaired swallowing safety). The maximum score is infinite as the number of occurrences of aspiration is counted in the total score. A higher score on the SSS indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The SSS was scored from videotaped swallows, by speech pathologists. The raters were blinded to the identity of the patient, group, and time post training.
Time frame: Baseline and 12-months post-treatment

Secondary outcomes

Penetration-Aspiration Scale for 10 ml Thin Liquid
Every 3 months swallowing was measured using the Penetration-Aspiration (P/A) Scale. The P/A scale is an 8-point interval scale measuring the depth to which material passes into the airway and the patients cough response. A score of 0 indicates no penetration or aspiration. A score of 8 indicates the presence of aspiration with no cough response. A higher score indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The P/A Scale was scored by speech pathologists blinded to the identity of the patient, group, and time post training, from videotaped swallows.
Time frame: Baseline and 12-months post-treatment
Penetration-Aspiration Scale for 5 ml Pudding
Every 3 months swallowing was measured using the Penetration-Aspiration (P/A) Scale. The P/A scale is an 8-point interval scale measuring the depth to which material passes into the airway and the patients cough response. A score of 0 indicates no penetration or aspiration. A score of 8 indicates the presence of aspiration with no cough response. A higher score indicates reduced swallowing safety. Swallows of 5 ml pudding, were captured during videofluoroscopy. The P/A Scale was scored by speech pathologists blinded to the identity of the patient, group, and time post training, from videotaped swallows.
Time frame: Baseline and 12-months post-treatment
Functional Oral Intake Scale (FOIS) for Dysphagia
The FOIS was administered at baseline and every 3 months post-treatment during the first year. The FOIS is a 7 point ordinal scale reflecting the functional oral intake of patients. A score of 1 indicates no oral nutrition; a score of 7 indicates all nutrition is taken orally.
Time frame: Baseline and 12-months post-treatment
Quality of Life Patient Questionnaire
The SWAL-QOL (Swallowing Quality of Life) questionnaire was administered at baseline and every 3 months during the first year. The SWAL-QOL is a 44 item tool that measure 10 quality of life domains, i.e., food selection, burden, mental health, social functioning, fear, eating duration, eating desire, communication, sleep, and fatigue. Scores range from 0 to 100. A lower score indicates greater impairment.
Time frame: Baseline and 12-months post-treatment

Results

Posted Oct 26, 2012

Participant flow

Participant flow — Overall Study
Milestone	Vibrotactile	Intramuscular
Started	4	6
Completed	4	4
Not completed	0	2
Withdrew: Death	0	2

Outcome measures

PrimarySwallowing Safety for 10 ml of Thin Liquid

Every 3 months swallowing safety was measured using the Swallowing Safety Scale (SSS). The SSS measures 11 swallowing variables including: the presence of residue in the valleculae, laryngeal vestibule, and/or pyriform sinuses, the presence of penetration arising from the oropharynx and/or the hypopharynx, the number of aspiration events arising from the oropharynx and/or the hypopharynx, response to aspiration, degree of esophageal entry, presence of regurgitation, and the presence of \>1 swallow per bolus. Scores range from 0 (safe swallowing) to \>5 (severely impaired swallowing safety). The maximum score is infinite as the number of occurrences of aspiration is counted in the total score. A higher score on the SSS indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The SSS was scored from videotaped swallows, by speech pathologists. The raters were blinded to the identity of the patient, group, and time post training.

Time frame:: Baseline and 12-months post-treatment
Reported as:: Mean · units on a scale

Swallowing Safety for 10 ml of Thin Liquid
units on a scale	Vibrotactile	Intramuscular
Baseline	8.417 ± 0.540	7.167 ± 1.347
12-months	8.250 ± 3.167	7.375 ± 1.250

SecondaryPenetration-Aspiration Scale for 10 ml Thin Liquid

Every 3 months swallowing was measured using the Penetration-Aspiration (P/A) Scale. The P/A scale is an 8-point interval scale measuring the depth to which material passes into the airway and the patients cough response. A score of 0 indicates no penetration or aspiration. A score of 8 indicates the presence of aspiration with no cough response. A higher score indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The P/A Scale was scored by speech pathologists blinded to the identity of the patient, group, and time post training, from videotaped swallows.

Time frame:: Baseline and 12-months post-treatment
Reported as:: Mean · units on a scale

Penetration-Aspiration Scale for 10 ml Thin Liquid
units on a scale	Vibrotactile	Intramuscular
Baseline	5.792 ± 0.854	5.000 ± 1.700
12 months	5.792 ± 2.451	4.292 ± 2.266

SecondaryPenetration-Aspiration Scale for 5 ml Pudding

Every 3 months swallowing was measured using the Penetration-Aspiration (P/A) Scale. The P/A scale is an 8-point interval scale measuring the depth to which material passes into the airway and the patients cough response. A score of 0 indicates no penetration or aspiration. A score of 8 indicates the presence of aspiration with no cough response. A higher score indicates reduced swallowing safety. Swallows of 5 ml pudding, were captured during videofluoroscopy. The P/A Scale was scored by speech pathologists blinded to the identity of the patient, group, and time post training, from videotaped swallows.

Time frame:: Baseline and 12-months post-treatment
Reported as:: Mean · units on a scale

Penetration-Aspiration Scale for 5 ml Pudding
units on a scale	Vibrotactile	Intramuscular
Baseline	1.417 ± 0.419	2.083 ± 1.067
12 months	2.333 ± 1.097	1.458 ± 0.417

PrimarySwallowing Safety for 5 ml of Pudding

Time frame:: Baseline and 12-months post-treatment
Reported as:: Mean · Units on a scale

Swallowing Safety for 5 ml of Pudding
Units on a scale	Vibrotactile	Intramuscular
Baseline	6.667 ± 0.272	6.917 ± 1.664
12-months	6.667 ± 0.871	6.583 ± 0.441

SecondaryFunctional Oral Intake Scale (FOIS) for Dysphagia

The FOIS was administered at baseline and every 3 months post-treatment during the first year. The FOIS is a 7 point ordinal scale reflecting the functional oral intake of patients. A score of 1 indicates no oral nutrition; a score of 7 indicates all nutrition is taken orally.

Time frame:: Baseline and 12-months post-treatment
Reported as:: Mean · units on a scale

Functional Oral Intake Scale (FOIS) for Dysphagia
units on a scale	Vibrotactile	Intramuscular
Baseline	1.0 ± 0.0	1.0 ± 0.0
12 months	3.250 ± 2.630	3.0 ± .816

SecondaryQuality of Life Patient Questionnaire

The SWAL-QOL (Swallowing Quality of Life) questionnaire was administered at baseline and every 3 months during the first year. The SWAL-QOL is a 44 item tool that measure 10 quality of life domains, i.e., food selection, burden, mental health, social functioning, fear, eating duration, eating desire, communication, sleep, and fatigue. Scores range from 0 to 100. A lower score indicates greater impairment.

Time frame:: Baseline and 12-months post-treatment
Reported as:: Mean · units on a scale

Quality of Life Patient Questionnaire
units on a scale	Vibrotactile	Intramuscular
Baseline	55.208 ± 7.311	51.389 ± 4.598
12 months	68.316 ± 15.829	57.726 ± 12.281

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Vibrotactile	—	2/4 (50%)	1/4 (25%)
Intramuscular	—	4/6 (66.7%)	5/6 (83.3%)

Most frequent serious events

Most frequent serious events
Event	Vibrotactile	Intramuscular
Deceased unrelated to studyNervous system disorders	0/4	2/6
Neurological symptoms following antibiotic administrationNervous system disorders	1/4	0/6
PEG site problemGastrointestinal disorders	1/4	0/6
Venous occlusion in eyeEye disorders	1/4	0/6
Decreased responsivenessNervous system disorders	0/4	1/6
Device malfunctionInjury, poisoning and procedural complications	0/4	1/6
FallNervous system disorders	0/4	1/6

Most frequent other events

Most frequent other events
Event	Vibrotactile	Intramuscular
SeromaSkin and subcutaneous tissue disorders	0/4	3/6
Upper Respiratory InfectionImmune system disorders	0/4	2/6
Complication of aspiration during VSERespiratory, thoracic and mediastinal disorders	0/4	2/6
FeverInfections and infestations	1/4	0/6
Neck irritation at suture siteSkin and subcutaneous tissue disorders	0/4	1/6
Panic AttackPsychiatric disorders	0/4	1/6
INS flippedInvestigations	0/4	1/6

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Vibrotactile	Intramuscular	Total
<=18 years	0	0	0
Between 18 and 65 years	1	2	3
>=65 years	3	4	7

Age Continuous
Age Continuous(years)	Vibrotactile	Intramuscular	Total
Mean	70.25 ± 13.2003	61.16 ± 17.702	64.8 ± 15.94

Sex: Female, Male
Sex: Female, Male(Participants)	Vibrotactile	Intramuscular	Total
Female	2	4	6
Male	2	2	4

Study locations

1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland 20892, United States

References and documents

Publications

Crary MA, Mann GD, Groher ME. Initial psychometric assessment of a functional oral intake scale for dysphagia in stroke patients. Arch Phys Med Rehabil. 2005 Aug;86(8):1516-20. doi: 10.1016/j.apmr.2004.11.049. PubMed 16084801 ↗
McHorney CA, Bricker DE, Kramer AE, Rosenbek JC, Robbins J, Chignell KA, Logemann JA, Clarke C. The SWAL-QOL outcomes tool for oropharyngeal dysphagia in adults: I. Conceptual foundation and item development. Dysphagia. 2000 Summer;15(3):115-21. doi: 10.1007/s004550010012. PubMed 10839823 ↗
Kahrilas PJ, Lin S, Rademaker AW, Logemann JA. Impaired deglutitive airway protection: a videofluoroscopic analysis of severity and mechanism. Gastroenterology. 1997 Nov;113(5):1457-64. doi: 10.1053/gast.1997.v113.pm9352847. PubMed 9352847 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00376506
Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party: Sponsor
First posted: Sep 15, 2006
Start date: Jul 2006
Primary completion: Sep 2010
Completion: Jan 2011
Results posted: Oct 26, 2012
Last update: Oct 26, 2012

View the source record on ClinicalTrials.gov ↗

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