Cortical Neuromodulation in Post Stroke Dysphagia | NCT01345890

Studies
Cortical Neuromodulation in Post Stroke Dysphagia

NCT01345890

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

Jun 18, 2013Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Dysphagia

Interventions

electrical stimulation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2010Actual

First Submitted Date

Feb 17, 2009

First Submission Date that Met QC Criteria

Apr 29, 2011

First Posted Date

May 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2013

Last Update Posted Date

Jun 18, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Aspiration could have fatal complication especially in post stroke dysphagia. The aim of this study is to improve post stroke dysphagia using electrical stimulation of mylohyoid muscles.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
electrical stimulation	Experimental	stroke patients	Procedure: electrical stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electrical stimulation	Procedure	sub motor threshold stimulation of mylohyoid muscles	electrical stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

post stroke dysphagia

Exclusion Criteria:

contraindication to magnetic stimulation, unability to accept the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric VERIN, MD-PhD	Rouen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rouen Universty Hospital		Rouen		76031	France

Condition Browse Module

MeSH Terms

ID	Term
D003680	Deglutition Disorders
D020521	Stroke

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004558	Electric Stimulation

Ancestor Terms

ID	Term
D010812	Physical Stimulation
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided