NCT01345890

Brief Summary

The investigators aim is to try to rehabilitate post stroke dysphagia using electrical stimulation of the mylohyoid muscles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

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, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

1.4 years

First QC Date

February 17, 2009

Last Update Submit

June 17, 2013

Conditions

Dysphagia

Keywords

swallowingstrokeaspirationhumanelectrical stimulationpost stroke dysphagia

Outcome Measures

Primary Outcomes (1)

  • videofluoroscopy

    measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing

    before and after (once a day for 5 consecutive days)

Study Arms (1)

electrical stimulation

EXPERIMENTAL

stroke patients

Procedure: electrical stimulation

Interventions

electrical stimulationPROCEDURE

sub motor threshold stimulation of mylohyoid muscles

electrical stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post stroke dysphagia

You may not qualify if:

  • contraindication to magnetic stimulation, unability to accept the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen Universty Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Deglutition DisordersStroke

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Officials

  • Eric VERIN, MD-PhD

    Rouen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2009

First Posted

May 2, 2011

Study Start

January 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2010

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

FR(1)