Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001936
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Electrical Muscle Stimulation to Aid Swallowing in Dysphagia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Feasibility of Neuromuscular Stimulation for Laryngeal Elevation During Swallowing
Status:
COMPLETED
Status Verified Date:
2009-08-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the feasibility of using extrinsic laryngeal muscle stimulation to elevate the larynx in a manner similar to that which occurs during normal swallowing This research will also determine whether laryngeal elevation will open the upper esophageal sphincter to assist with entry of the bolus into the esophagus This protocol includes studies in normal volunteers and patients with swallowing disorders The outcome of this study will be relevant to future use of neuromuscular stimulation for laryngeal elevation in patients with pharyngeal dysphagia
Detailed Description:
Objectives
1 To determine if stimulation of the extrinsic laryngeal muscles will elevate the larynx
2 To determine if augmentation of laryngeal elevation using intra-muscular stimulation will reduce the risk of aspiration in chronic pharyngeal dysphagia
3 To determine whether stimulation to induce laryngeal elevation assists with opening the upper esophageal sphincter both at rest and during swallowing
4 To determine whether laryngeal sensation is intact has bearing on the ability of patients with chronic dysphagia to trigger the onset of stimulation in synchrony with their own swallowing
5 To contrast the effects of surface and intra-muscular stimulation on hyo-laryngeal movement at rest
6 To contrast the benefits of surface and intra-muscular stimulation on the risk or aspirationpenetration during swallowing
Study Population Both normal volunteers and patients with severe chronic pharyngeal dysphagia
Design Hooked wire electrodes and surface electrodes will be used to stimulate extrinsic muscles either alone or in combination both at rest and during swallowing while using videofluoroscopy 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 manometric pressure recordings and cricopharyngeus electromyography will evaluate the effects of muscles stimulation on the upper esophageal sphincter function and blinded ratings of the degree of aspiration and penetration and clearance during swallowing will be conducted by speech-language pathologists to compare the effects of intra-muscular and surface stimulation on swallowing on risk of aspiration and penetration during swallowing
1 To determine if stimulation of the extrinsic laryngeal muscles will elevate the larynx
2 To determine if augmentation of laryngeal elevation using intra-muscular stimulation will reduce the risk of aspiration in chronic pharyngeal dysphagia
3 To determine whether stimulation to induce laryngeal elevation assists with opening the upper esophageal sphincter both at rest and during swallowing
4 To determine whether laryngeal sensation is intact has bearing on the ability of patients with chronic dysphagia to trigger the onset of stimulation in synchrony with their own swallowing
5 To contrast the effects of surface and intra-muscular stimulation on hyo-laryngeal movement at rest
6 To contrast the benefits of surface and intra-muscular stimulation on the risk or aspirationpenetration during swallowing
Study Population Both normal volunteers and patients with severe chronic pharyngeal dysphagia
Design Hooked wire electrodes and surface electrodes will be used to stimulate extrinsic muscles either alone or in combination both at rest and during swallowing while using videofluoroscopy 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 manometric pressure recordings and cricopharyngeus electromyography will evaluate the effects of muscles stimulation on the upper esophageal sphincter function and blinded ratings of the degree of aspiration and penetration and clearance during swallowing will be conducted by speech-language pathologists to compare the effects of intra-muscular and surface stimulation on swallowing on risk of aspiration and penetration during swallowing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-N-0178 | None | None | None |