HealthyNCT00104000
Effect of Surface Electrical Stimulation on Movement of the Larynx
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine whether surface electrical stimulation on the skin of the throat will: 1) move the larynx (voice box); 2) move the vocal folds in the larynx; and 3) cause less movement of the larynx when applied during swallowing. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jan 2006
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The Healthy volunteers will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech, swallowing and hearing problems as determined by medical history and examination by a physician.
Who cannot join
- History of Rheumatic fever, mitral valve prolapse, or cardiac arrhythmias as determined by medical history, physical and EKG. A physician will auscultate for cardiac murmurs prior to any study to exclude volunteers who might be at risk for endocarditis. Subjects will have an EKG as part of the screening for participation in the study.
- Pregnancy will exclude women from participation because the study involves radiation exposure.
- None of the Healthy volunteers will have a reduction in the range of vocal fold movement during the nasoendoscopy that might suggest laryngeal paralysis or paresis, joint abnormality or neoplasm.
- Healthy Volunteers who have a cardiac demand pacemaker, dementia, exhibit non-stop vocalization, significant reflux due to use of a feeding tube, or drug toxicity will not be included for VitalStim, as these are contraindications to use of the device.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: The Effect of Surface Electrical Stimulation on Hyo-Laryngeal Movement in Healthy Individuals at Rest and During Swallow
This study will examine whether surface electrical stimulation on the skin of the throat will: 1) move the larynx (voice box); 2) move the vocal folds in the larynx; and 3) cause less movement of the larynx when applied during swallowing. It is important that the larynx moves up and forward while swallowing so that food does not go into the airway. A device called VitalStim® (Registered Trademark), which provides electrical stimulation to the skin on the neck and under the chin, is widely used to treat people who have problems swallowing. This study will determine if VitalStim can move the voice box or the vocal folds in the larynx. This information is important for patients who have long-term problems raising or closing their larynxes when they swallow.
Healthy volunteers between 20 and 60 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, and nasoendoscopy. For the latter procedure, the inside of the subject's nose is sprayed with a decongestant, opening the nasal passages. A small flexible tube called a nasoendoscope is passed through the nose to the back of the throat. The scope allows observation of the larynx while the subject speaks, sings, whistles and makes prolonged vowel sounds.
Read more
Participants are familiarized with the VitalStim device before beginning the experimental procedures. The device consists of two sets of electrodes and a stimulation unit. The electrodes are placed on the neck and under the chin. Stimulation causes different sensations, according to the intensity level. They include "tingling/crawling," "vibrating" "warm/burning," and "grabbing." Subjects then undergo the following procedures:
- Nasoendoscopy with muscle stimulation: The inside of the nose is sprayed with a decongestant and the nasoendoscope is passed through one nostril to the back of the throat. Electrodes are placed on the throat area and under the chin. Stimulation is delivered 10 times at various places on the neck and under the chin while the subject sits quietly. This test shows if the vocal folds in the voice box move with surface electrical stimulation.
- Videofluoroscopy with muscle stimulation at rest and during swallowing: This is an x-ray study of the head and neck during swallowing and at rest to determine how stimulation affects the level of the voice box in the neck. Electrodes are placed under the chin and on the throat. The subject swallows 5 milliliters of barium, a contrast material that can be seen easily on x-ray. The x-ray machine is turned on for a few seconds at a time during each swallow of the barium and another 10 times while the subject is remaining still without swallowing.
Read the detailed description
Objectives:
The purpose of the current study is to determine whether:
- Surface electrical stimulation at rest using various electrode placements produces different hyo-laryngeal movements of in healthy adult humans.
- One surface electrical stimulation array (placement 3b) reduces hyo-larynegeal movement in healthy humans during swallowing.
Study Population: healthy adults
Design: This study will employ a repeated measures design. Surface electrodes will be used to stimulate submental and laryngeal muscles either alone or in combination both at rest and during swallowing while using videofluoroscopy and nasolaryngoscopy to record hyo-laryngeal movement.
Outcome Measures: Kinematic analyses of hyo-laryngeal movements using image processing and marking from video-recordings will quantify movement with stimulation.
- Conditions
- Healthy
- Keywords
- Neuromuscular, Elevation, Current, Videofluoroscopy, Nasoendoscopy, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2005 (estimated)
- Study startFeb 2005
- Study completionJan 2006
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 HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 47 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104000
- Sponsor's protocol ID
- 050099
- Other IDs
- 05-N-0099
- Status last verified
- Jan 2006
- First submitted
- 17 Feb 2005
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Lundy DS, Smith C, Colangelo L, Sullivan PA, Logemann JA, Lazarus CL, Newman LA, Murry T, Lombard L, Gaziano J. Aspiration: cause and implications. Otolaryngol Head Neck Surg. 1999 Apr;120(4):474-8. doi: 10.1053/hn.1999.v120.a91765.
PubMed 10187936Kahrilas 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 9352847ECRI Health Technology Assessment Group. Diagnosis and treatment of swallowing disorders (dysphagia) in acute-care stroke patients. Evid Rep Technol Assess (Summ). 1999 Mar;(8):1-6. No abstract available.
PubMed 11925971
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
- The Effect of Surface Electrical Stimulation on Hyo-Laryngeal Movement in Healthy Individuals at Rest and During Swallow
- ClinicalTrials.gov ID
- NCT00104000
- Acronym / sponsor ID
- 050099
- Conditions
- Healthy
- Keywords
- Neuromuscular, Elevation, Current, Videofluoroscopy, Nasoendoscopy, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Feb 2005
- Study completion
- Jan 2006
- First posted
- 18 Feb 2005 (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.
This study will examine whether surface electrical stimulation on the skin of the throat will: 1) move the larynx (voice box); 2) move the vocal folds in the larynx; and 3) cause less movement of the larynx when applied during swallowing. It is important that the larynx moves up and forward while swallowing so that food does not go into the airway. A device called VitalStim® (Registered Trademark), which provides electrical stimulation to the skin on the neck and under the chin, is widely used to treat people who have problems swallowing. This study will determine if VitalStim can move the voice box or the vocal folds in the larynx. This information is important for patients who have long-term problems raising or closing their larynxes when they swallow.
Healthy volunteers between 20 and 60 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, and nasoendoscopy. For the latter procedure, the inside of the subject's nose is sprayed with a decongestant, opening the nasal passages. A small flexible tube called a nasoendoscope is passed through the nose to the back of the throat. The scope allows observation of the larynx while the subject speaks, sings, whistles and makes prolonged vowel sounds.
Participants are familiarized with the VitalStim device before beginning the experimental procedures. The device consists of two sets of electrodes and a stimulation unit. The electrodes are placed on the neck and under the chin. Stimulation causes different sensations, according to the intensity level. They include "tingling/crawling," "vibrating" "warm/burning," and "grabbing." Subjects then undergo the following procedures:
- Nasoendoscopy with muscle stimulation: The inside of the nose is sprayed with a decongestant and the nasoendoscope is passed through one nostril to the back of the throat. Electrodes are placed on the throat area and under the chin. Stimulation is delivered 10 times at various places on the neck and under the chin while the subject sits quietly. This test shows if the vocal folds in the voice box move with surface electrical stimulation.
- Videofluoroscopy with muscle stimulation at rest and during swallowing: This is an x-ray study of the head and neck during swallowing and at rest to determine how stimulation affects the level of the voice box in the neck. Electrodes are placed under the chin and on the throat. The subject swallows 5 milliliters of barium, a contrast material that can be seen easily on x-ray. The x-ray machine is turned on for a few seconds at a time during each swallow of the barium and another 10 times while the subject is remaining still without swallowing.
Detailed description
Objectives:
The purpose of the current study is to determine whether:
- Surface electrical stimulation at rest using various electrode placements produces different hyo-laryngeal movements of in healthy adult humans.
- One surface electrical stimulation array (placement 3b) reduces hyo-larynegeal movement in healthy humans during swallowing.
Study Population: healthy adults
Design: This study will employ a repeated measures design. Surface electrodes will be used to stimulate submental and laryngeal muscles either alone or in combination both at rest and during swallowing while using videofluoroscopy and nasolaryngoscopy to record hyo-laryngeal movement.
Outcome Measures: Kinematic analyses of hyo-laryngeal movements using image processing and marking from video-recordings will quantify movement with stimulation.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The Healthy volunteers will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech, swallowing and hearing problems as determined by medical history and examination by a physician.
Key exclusion criteria (4 listed)
- History of Rheumatic fever, mitral valve prolapse, or cardiac arrhythmias as determined by medical history, physical and EKG. A physician will auscultate for cardiac murmurs prior to any study to exclude volunteers who might be at risk for endocarditis. Subjects will have an EKG as part of the screening for participation in the study.
- Pregnancy will exclude women from participation because the study involves radiation exposure.
- None of the Healthy volunteers will have a reduction in the range of vocal fold movement during the nasoendoscopy that might suggest laryngeal paralysis or paresis, joint abnormality or neoplasm.
- Healthy Volunteers who have a cardiac demand pacemaker, dementia, exhibit non-stop vocalization, significant reflux due to use of a feeding tube, or drug toxicity will not be included for VitalStim, as these are contraindications to use of the device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 10187936Lundy DS, Smith C, Colangelo L, Sullivan PA, Logemann JA, Lazarus CL, Newman LA, Murry T, Lombard L, Gaziano J. Aspiration: cause and implications. Otolaryngol Head Neck Surg. 1999 Apr;120(4):474-8. doi: 10.1053/hn.1999.v120.a91765.
- Background: PubMed 9352847Kahrilas 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.
- Background: PubMed 11925971ECRI Health Technology Assessment Group. Diagnosis and treatment of swallowing disorders (dysphagia) in acute-care stroke patients. Evid Rep Technol Assess (Summ). 1999 Mar;(8):1-6. No abstract available.
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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?
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
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 NCT00104000, 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.