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

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ClinicalTrials.gov Identifier: NCT00376506
Recruitment Status : Completed
First Posted : September 15, 2006
Results First Posted : October 26, 2012
Last Update Posted : October 26, 2012
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single;   Primary Purpose: Treatment
Conditions Chronic Dysphagia
Multiple Sclerosis
Parkinson Disease
Interventions Device: Neurostimulation device for dysphagia
Device: External vibrotactile device
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vibrotactile Intramuscular
Hide Arm/Group Description An external vibrotactile device used for swallowing retraining An implanted neurostimulator device used for swallowing retraining
Period Title: Overall Study
Started 4 6
Completed 4 4
Not Completed 0 2
Reason Not Completed
Death             0             2
Arm/Group Title Vibrotactile Intramuscular Total
Hide Arm/Group Description An external vibrotactile device used for swallowing retraining An implanted neurostimulator device used for swallowing retraining Total of all reporting groups
Overall Number of Baseline Participants 4 6 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  25.0%
2
  33.3%
3
  30.0%
>=65 years
3
  75.0%
4
  66.7%
7
  70.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 6 participants 10 participants
70.25  (13.2003) 61.16  (17.702) 64.8  (15.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 10 participants
Female
2
  50.0%
4
  66.7%
6
  60.0%
Male
2
  50.0%
2
  33.3%
4
  40.0%
1.Primary Outcome
Title Swallowing Safety for 10 ml of Thin Liquid
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Vibrotactile Intramuscular
Hide Arm/Group Description:
Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
Patients used a surgically implanted intramuscular stimulation device. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 8.417  (0.540) 7.167  (1.347)
12-months 8.250  (3.167) 7.375  (1.250)
2.Primary Outcome
Title Swallowing Safety for 5 ml of Pudding
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Vibrotactile Intramuscular
Hide Arm/Group Description:
Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
Patients used a surgically implanted intramuscular stimulation device. Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 6.667  (0.272) 6.917  (1.664)
12-months 6.667  (0.871) 6.583  (0.441)
3.Secondary Outcome
Title Penetration-Aspiration Scale for 10 ml Thin Liquid
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Vibrotactile Intramuscular
Hide Arm/Group Description:
Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
Patients utilized an implanted neurostimulator device for swallowing. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.retraining
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.792  (0.854) 5.000  (1.700)
12 months 5.792  (2.451) 4.292  (2.266)
4.Secondary Outcome
Title Penetration-Aspiration Scale for 5 ml Pudding
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Vibrotactile Intramuscular
Hide Arm/Group Description:
Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
Patients utilized an implanted neurostimulator device for swallowing retraining. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 1.417  (0.419) 2.083  (1.067)
12 months 2.333  (1.097) 1.458  (0.417)
5.Secondary Outcome
Title Functional Oral Intake Scale (FOIS) for Dysphagia
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Vibrotactile Intramuscular
Hide Arm/Group Description:
Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
Patients used a surgically implanted intramuscular stimulation device. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 1.0  (0.0) 1.0  (0.0)
12 months 3.250  (2.630) 3.0  (.816)
6.Secondary Outcome
Title Quality of Life Patient Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Vibrotactile Intramuscular
Hide Arm/Group Description:
Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
Patients utilized an implanted neurostimulator device for swallowing retraining. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 55.208  (7.311) 51.389  (4.598)
12 months 68.316  (15.829) 57.726  (12.281)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vibrotactile Intramuscular
Hide Arm/Group Description An external vibrotactile device used for swallowing retraining An implanted neurostimulator device used for swallowing retraining
All-Cause Mortality
Vibrotactile Intramuscular
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Vibrotactile Intramuscular
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      4/6 (66.67%)    
Eye disorders     
Venous occlusion in eye  1/4 (25.00%)  1 0/6 (0.00%)  0
Gastrointestinal disorders     
PEG site problem  1/4 (25.00%)  1 0/6 (0.00%)  0
Injury, poisoning and procedural complications     
Device malfunction  0/4 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders     
Decreased responsiveness  0/4 (0.00%)  0 1/6 (16.67%)  1
Neurological symptoms following antibiotic administration  1/4 (25.00%)  1 0/6 (0.00%)  0
Fall  0/4 (0.00%)  0 1/6 (16.67%)  1
Deceased unrelated to study  0/4 (0.00%)  0 2/6 (33.33%)  2
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Vibrotactile Intramuscular
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      5/6 (83.33%)    
Immune system disorders     
Upper Respiratory Infection  0/4 (0.00%)  0 2/6 (33.33%)  2
Infections and infestations     
Fever  1/4 (25.00%)  1 0/6 (0.00%)  0
Investigations     
INS flipped  0/4 (0.00%)  0 1/6 (16.67%)  2
Psychiatric disorders     
Panic Attack  0/4 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders     
Complication of aspiration during VSE  0/4 (0.00%)  0 2/6 (33.33%)  2
Skin and subcutaneous tissue disorders     
Neck irritation at suture site  0/4 (0.00%)  0 1/6 (16.67%)  1
Seroma  0/4 (0.00%)  0 3/6 (50.00%)  3
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christy L. Ludlow, PhD
Organization: James Madison University
Phone: 540-568-3876
EMail: ludlowcx@jmu.edu
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT00376506    
Other Study ID Numbers: 060212
06-N-0212
First Submitted: September 14, 2006
First Posted: September 15, 2006
Results First Submitted: November 1, 2011
Results First Posted: October 26, 2012
Last Update Posted: October 26, 2012