NCT01765673

Brief Summary

This is a device evaluation study to determine the optimal stimulation characteristics for using vibrotactile stimulation as a sensory triggering device for self retraining in patients with chronic moderate to severe dysphagia. Stimulation characteristics to be tested are frequency of vibration, pressure between the device and the skin, mode of vibration (pulsed or continuous).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2016

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 14, 2017

Completed
Last Updated

November 14, 2017

Status Verified

September 1, 2017

Enrollment Period

3.1 years

First QC Date

January 8, 2013

Results QC Date

May 20, 2017

Last Update Submit

October 17, 2017

Conditions

Oropharyngeal Dysphagia

Keywords

SwallowingStrokeSensory stimulationHome based therapyHead and Neck Cancer

Outcome Measures

Primary Outcomes (5)

  • Change in Swallow Frequency 30 Hz

    Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)

    During one session within 1 hour

  • Change in Swallow Frequency 70 Hz

    Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)

    During one session within 1 hour

  • Change in Swallow Frequency 110 Hz

    Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)

    During one session within 1 hour

  • Change in Swallow Frequency 150 Hz

    Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)

    During one session within 1 hour

  • Change in Swallowing Frequency 70 & 110 Hz

    Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)

    During one session within 1 hour

Secondary Outcomes (15)

  • Change in Urge to Swallow After 30 Hz Stimulation

    During one session within 1 hour

  • Change in Urge to Swallow 70 Hz

    During one session within 1 hour

  • Change in VAS Urge to Swallow 110 Hz

    During one session within 1 hour

  • Change in VAS Urge to Swallow 150 Hz

    During one session within 1 hour

  • Change in VAS Urge to Swallow 70 & 110 Hz

    During one session within 1 hour

  • +10 more secondary outcomes

Study Arms (1)

Vibrotactile Stimulation in Dysphagia

A Vibrotactile stimulation device will be evaluated in patients with chronic moderate to severe dysphagia for more than 6 months post onset due to stroke or following radiation treatment for head and neck cancer to assess which frequency, mode, pressure characteristics are most helpful in increasing the rate of swallowing, increasing the urge to swallow, assisting with the initiation of swallowing and not affecting discomfort.

Device: Vibrotactile stimulation

Interventions

Vibrotactile stimulationDEVICE

Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.

Also known as: Passy Muir Swallowing Serlf Trainer
Vibrotactile Stimulation in Dysphagia

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who have swallowing problems secondary to a stroke or following radiation for the treatment of head and neck cancer

You may qualify if:

  • Stroke or post radiation for the treatment of head and neck cancer
  • Dysphagia with a score of 2 or greater on the Penetration/Aspiration Scale OR a Mann Assessment of Swallowing Ability ordinal risk rating of "probable" or "definite"

You may not qualify if:

  • Neck injury
  • Epilepsy
  • Neurological disorder other than stroke
  • Psychiatric illness other than depression
  • Uncontrolled gastroesophageal reflux disease
  • Inability to communicate secondary to significant speech or language problems
  • Inability to maintain alertness for 1 hour
  • Significant health concerns that would put the participant at risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Madison University and Rockingham Memorial Hospital

Harrisonburg, Virginia, 22801, United States

Location

Related Publications (2)

  • Theurer JA, Bihari F, Barr AM, Martin RE. Oropharyngeal stimulation with air-pulse trains increases swallowing frequency in healthy adults. Dysphagia. 2005 Fall;20(4):254-60. doi: 10.1007/s00455-005-0021-1.

    PMID: 16633868RESULT

  • Theurer JA, Czachorowski KA, Martin LP, Martin RE. Effects of oropharyngeal air-pulse stimulation on swallowing in healthy older adults. Dysphagia. 2009 Sep;24(3):302-13. doi: 10.1007/s00455-009-9207-2. Epub 2009 Apr 24.

    PMID: 19390893RESULT

MeSH Terms

Conditions

Deglutition DisordersStrokeHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeoplasms by SiteNeoplasms

Limitations and Caveats

Recruitment was lower than anticipated, we were only able to recruit 12 participants rather than the 15 needed Participants found it burdensome to travel to the testing facility when there was no possible benefit to them for participation

Results Point of Contact

Title
Christy Ludlow
Organization
James Madison University
ludlowcx@jmu.edu
540-937-3007

Study Officials

  • Christy L Ludlow, PhD

    James Madison University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 10, 2013

Study Start

January 1, 2013

Primary Completion

February 22, 2016

Study Completion

February 22, 2016

Last Updated

November 14, 2017

Results First Posted

November 14, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)