Deglutition DisordersNCT00001718
Facilitation of Oral Bolus Propulsion Using Electropalatography in Patients With Dysphagia
A study testing Electropalatography in people with Deglutition Disorders and Dysphagia, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Electropalatography (EPG), a noninvasive device that provides specific visual output on tongue-palate contact, has well-established usefulness as a biofeedback tool in speech therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deglutition Disorders, Dysphagia
- What is being tested?
- Electropalatography
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1998to Jun 2000
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Patients who have undergone comprehensive swallowing evaluations (i.e., ultrasound and/or videofluoroscopic swallow studies, oral sensorimotor examination, and swallowing questionnaire) in the Speech Pathology Section and have been found to have dysphagia with prominent oral signs.
All subjects must be alert and oriented to time and place, able to ingest food by mouth, and have intact or aided hearing and vision.
No patients that exhibit oral apraxia, dementia, aphasia, behavioral problems, and endentousness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Electropalatography (EPG), a noninvasive device that provides specific visual output on tongue-palate contact, has well-established usefulness as a biofeedback tool in speech therapy. While EPG has also been shown to be capable of revealing the details of linguopalatal interactions during swallowing, its applicability in swallowing therapy has not been evaluated to date. This study will determine if EPG can facilitate bolus propulsion in patients presenting with swallowing problems of the oral phase. Seven patients with oral dysphagia will be selected to serve as subjects based on specific inclusion and exclusion criteria, and each will be custom-fitted with a pseudo-palate. Each patient will undergo four 45-minute sessions of biofeedback training with emphasis on developing systematic front-to-back anchoring of the tongue against the palate during propulsion of liquid and semisolid boluses. Ultrasound imaging will be used to determine swallow durations and identify oral deficits of swallowing before the EPG biofeedback training, and to identify any changes that may result from the training. Quantitative measurements will also be made of the swallow-related EPG contact timing and pattern before and after training and compared for each individual subject as a function of training and bolus volume. Appropriate statistical analyses will be conducted.
Read the detailed description
Electropalatography (EPG), a noninvasive device that provides specific visual output on tongue-palate contact, has well-established usefulness as a biofeedback tool in speech therapy. While EPG has also been shown to be capable of revealing the details of linguopalatal interactions during swallowing, its applicability in swallowing therapy has not been evaluated to date. This study will determine if EPG can facilitate bolus propulsion in patients presenting with swallowing problems of the oral phase. Ten patients with oral dysphagia will be selected to serve as subjects based on specific inclusion and exclusion criteria, and each will be custom-fitted with a pseudo-palate. Each patient will undergo four 45-minute sessions of biofeedback training with emphasis on developing systematic front-to-back anchoring of the tongue against the palate during propulsion of liquid and semisolid boluses. Ultrasound imaging will be used to determine swallow durations and identify oral deficits of swallowing before the EPG biofeedback training, and to identify any changes that may result from the training. Quantitative measurements will also be made of the swallow-related EPG contact timing and pattern before and after training and compared for each individual subject as a function of training and bolus volume. Appropriate statistical analyses will be conducted.
- Conditions
- Deglutition Disorders, Dysphagia
- Being tested
- Electropalatography
- Keywords
- Biofeedback, Swallowing, Swallowing Therapy, Tongue/Palate, Ultrasound, Dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectropalatographyDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJul 1998
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001718
- Sponsor's protocol ID
- 980135
- Other IDs
- 98-CC-0135
- Status last verified
- Jul 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Chi-Fishman G, Stone M. A new application for electropalatography: swallowing. Dysphagia. 1996 Fall;11(4):239-47. doi: 10.1007/BF00265208.
PubMed 8870350Chi-Fishman G, Stone M, McCall GN. Lingual action in normal sequential swallowing. J Speech Lang Hear Res. 1998 Aug;41(4):771-85. doi: 10.1044/jslhr.4104.771.
PubMed 9712125Logemann JA, Kahrilas PJ, Hurst P, Davis J, Krugler C. Effects of intraoral prosthetics on swallowing in patients with oral cancer. Dysphagia. 1989;4(2):118-20. doi: 10.1007/BF02407156.
PubMed 2701094
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitation of Oral Bolus Propulsion Using Electropalatography in Patients With Dysphagia
- ClinicalTrials.gov ID
- NCT00001718
- Acronym / sponsor ID
- 980135
- Conditions
- Deglutition Disorders, Dysphagia
- Keywords
- Biofeedback, Swallowing, Swallowing Therapy, Tongue/Palate, Ultrasound, Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Jul 1998
- Study completion
- Jun 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electropalatography (EPG), a noninvasive device that provides specific visual output on tongue-palate contact, has well-established usefulness as a biofeedback tool in speech therapy. While EPG has also been shown to be capable of revealing the details of linguopalatal interactions during swallowing, its applicability in swallowing therapy has not been evaluated to date. This study will determine if EPG can facilitate bolus propulsion in patients presenting with swallowing problems of the oral phase. Seven patients with oral dysphagia will be selected to serve as subjects based on specific inclusion and exclusion criteria, and each will be custom-fitted with a pseudo-palate. Each patient will undergo four 45-minute sessions of biofeedback training with emphasis on developing systematic front-to-back anchoring of the tongue against the palate during propulsion of liquid and semisolid boluses. Ultrasound imaging will be used to determine swallow durations and identify oral deficits of swallowing before the EPG biofeedback training, and to identify any changes that may result from the training. Quantitative measurements will also be made of the swallow-related EPG contact timing and pattern before and after training and compared for each individual subject as a function of training and bolus volume. Appropriate statistical analyses will be conducted.
Detailed description
Electropalatography (EPG), a noninvasive device that provides specific visual output on tongue-palate contact, has well-established usefulness as a biofeedback tool in speech therapy. While EPG has also been shown to be capable of revealing the details of linguopalatal interactions during swallowing, its applicability in swallowing therapy has not been evaluated to date. This study will determine if EPG can facilitate bolus propulsion in patients presenting with swallowing problems of the oral phase. Ten patients with oral dysphagia will be selected to serve as subjects based on specific inclusion and exclusion criteria, and each will be custom-fitted with a pseudo-palate. Each patient will undergo four 45-minute sessions of biofeedback training with emphasis on developing systematic front-to-back anchoring of the tongue against the palate during propulsion of liquid and semisolid boluses. Ultrasound imaging will be used to determine swallow durations and identify oral deficits of swallowing before the EPG biofeedback training, and to identify any changes that may result from the training. Quantitative measurements will also be made of the swallow-related EPG contact timing and pattern before and after training and compared for each individual subject as a function of training and bolus volume. Appropriate statistical analyses will be conducted.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electropalatography | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8870350Chi-Fishman G, Stone M. A new application for electropalatography: swallowing. Dysphagia. 1996 Fall;11(4):239-47. doi: 10.1007/BF00265208.
- Background: PubMed 9712125Chi-Fishman G, Stone M, McCall GN. Lingual action in normal sequential swallowing. J Speech Lang Hear Res. 1998 Aug;41(4):771-85. doi: 10.1044/jslhr.4104.771.
- Background: PubMed 2701094Logemann JA, Kahrilas PJ, Hurst P, Davis J, Krugler C. Effects of intraoral prosthetics on swallowing in patients with oral cancer. Dysphagia. 1989;4(2):118-20. doi: 10.1007/BF02407156.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electropalatography in people with Deglutition Disorders and Dysphagia, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001718, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.