Trial Outcomes & Findings for A Comparison of an Implanted Neuroprosthesis With Sensory Training for Improving Airway Protection in Chronic Dysphagia (NCT NCT00376506)
NCT ID: NCT00376506
Last Updated: 2012-10-26
Results Overview
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.
COMPLETED
PHASE2
10 participants
Baseline and 12-months post-treatment
2012-10-26
Participant Flow
Participant milestones
| Measure |
Vibrotactile
An external vibrotactile device used for swallowing retraining
|
Intramuscular
An implanted neurostimulator device used for swallowing retraining
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Vibrotactile
An external vibrotactile device used for swallowing retraining
|
Intramuscular
An implanted neurostimulator device used for swallowing retraining
|
|---|---|---|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
A Comparison of an Implanted Neuroprosthesis With Sensory Training for Improving Airway Protection in Chronic Dysphagia
Baseline characteristics by cohort
| Measure |
Vibrotactile
n=4 Participants
An external vibrotactile device used for swallowing retraining
|
Intramuscular
n=6 Participants
An implanted neurostimulator device used for swallowing retraining
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age Continuous
|
70.25 years
STANDARD_DEVIATION 13.2003 • n=5 Participants
|
61.16 years
STANDARD_DEVIATION 17.702 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 15.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12-months post-treatmentPopulation: Intention to treat
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.
Outcome measures
| Measure |
Vibrotactile
n=4 Participants
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.
|
Intramuscular
n=4 Participants
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.
|
|---|---|---|
|
Swallowing Safety for 10 ml of Thin Liquid
Baseline
|
8.417 units on a scale
Standard Deviation 0.540
|
7.167 units on a scale
Standard Deviation 1.347
|
|
Swallowing Safety for 10 ml of Thin Liquid
12-months
|
8.250 units on a scale
Standard Deviation 3.167
|
7.375 units on a scale
Standard Deviation 1.250
|
PRIMARY outcome
Timeframe: Baseline and 12-months post-treatmentPopulation: intention to treat
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.
Outcome measures
| Measure |
Vibrotactile
n=4 Participants
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.
|
Intramuscular
n=4 Participants
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.
|
|---|---|---|
|
Swallowing Safety for 5 ml of Pudding
Baseline
|
6.667 Units on a scale
Standard Deviation 0.272
|
6.917 Units on a scale
Standard Deviation 1.664
|
|
Swallowing Safety for 5 ml of Pudding
12-months
|
6.667 Units on a scale
Standard Deviation 0.871
|
6.583 Units on a scale
Standard Deviation 0.441
|
SECONDARY outcome
Timeframe: Baseline and 12-months post-treatmentPopulation: intention to treat
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.
Outcome measures
| Measure |
Vibrotactile
n=4 Participants
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.
|
Intramuscular
n=4 Participants
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.
|
|---|---|---|
|
Penetration-Aspiration Scale for 10 ml Thin Liquid
12 months
|
5.792 units on a scale
Standard Deviation 2.451
|
4.292 units on a scale
Standard Deviation 2.266
|
|
Penetration-Aspiration Scale for 10 ml Thin Liquid
Baseline
|
5.792 units on a scale
Standard Deviation 0.854
|
5.000 units on a scale
Standard Deviation 1.700
|
SECONDARY outcome
Timeframe: Baseline and 12-months post-treatmentPopulation: intention to treat
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.
Outcome measures
| Measure |
Vibrotactile
n=4 Participants
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.
|
Intramuscular
n=4 Participants
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.
|
|---|---|---|
|
Penetration-Aspiration Scale for 5 ml Pudding
Baseline
|
1.417 units on a scale
Standard Deviation 0.419
|
2.083 units on a scale
Standard Deviation 1.067
|
|
Penetration-Aspiration Scale for 5 ml Pudding
12 months
|
2.333 units on a scale
Standard Deviation 1.097
|
1.458 units on a scale
Standard Deviation 0.417
|
SECONDARY outcome
Timeframe: Baseline and 12-months post-treatmentPopulation: intention to treat
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.
Outcome measures
| Measure |
Vibrotactile
n=4 Participants
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.
|
Intramuscular
n=4 Participants
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.
|
|---|---|---|
|
Functional Oral Intake Scale (FOIS) for Dysphagia
Baseline
|
1.0 units on a scale
Standard Deviation 0.0
|
1.0 units on a scale
Standard Deviation 0.0
|
|
Functional Oral Intake Scale (FOIS) for Dysphagia
12 months
|
3.250 units on a scale
Standard Deviation 2.630
|
3.0 units on a scale
Standard Deviation .816
|
SECONDARY outcome
Timeframe: Baseline and 12-months post-treatmentPopulation: intention to treat
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.
Outcome measures
| Measure |
Vibrotactile
n=4 Participants
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.
|
Intramuscular
n=4 Participants
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.
|
|---|---|---|
|
Quality of Life Patient Questionnaire
Baseline
|
55.208 units on a scale
Standard Deviation 7.311
|
51.389 units on a scale
Standard Deviation 4.598
|
|
Quality of Life Patient Questionnaire
12 months
|
68.316 units on a scale
Standard Deviation 15.829
|
57.726 units on a scale
Standard Deviation 12.281
|
Adverse Events
Vibrotactile
Intramuscular
Serious adverse events
| Measure |
Vibrotactile
n=4 participants at risk
An external vibrotactile device used for swallowing retraining
|
Intramuscular
n=6 participants at risk
An implanted neurostimulator device used for swallowing retraining
|
|---|---|---|
|
Nervous system disorders
Decreased responsiveness
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Neurological symptoms following antibiotic administration
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Fall
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
PEG site problem
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Venous occlusion in eye
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Deceased unrelated to study
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
Other adverse events
| Measure |
Vibrotactile
n=4 participants at risk
An external vibrotactile device used for swallowing retraining
|
Intramuscular
n=6 participants at risk
An implanted neurostimulator device used for swallowing retraining
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Neck irritation at suture site
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Seroma
|
0.00%
0/4
|
50.0%
3/6 • Number of events 3
|
|
Immune system disorders
Upper Respiratory Infection
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Complication of aspiration during VSE
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
|
Infections and infestations
Fever
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
|
Investigations
INS flipped
|
0.00%
0/4
|
16.7%
1/6 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place