NCT02170454

Brief Summary

The aim of this study is to test the hypothesis that rTMS on the dominant swallowing hemisphere is able to modify swallowing coordination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

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

June 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5.1 years until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

5 months

First QC Date

February 17, 2009

Last Update Submit

June 17, 2014

Conditions

Oropharyngeal Dysphagia

Keywords

neuromodulationswallowingmagnetic stimulationhealthy subjects

Outcome Measures

Primary Outcomes (1)

  • pharyngeal pressure

    Swallowing function will be studied before and after rTMS with videomanometry

    Day 1

Secondary Outcomes (1)

  • swallowing time

    Day 1

Study Arms (2)

rTMS

ACTIVE COMPARATOR

rTMS on pharyngeal cortical area in healthy subjects

Procedure: magnetic stimulation

Placebo

PLACEBO COMPARATOR

Sham rTMS on pharyngeal cortical area in healthy subjects

Procedure: magnetic stimulation

Interventions

magnetic stimulationPROCEDURE

rTMS on pharyngeal cortical area in healthy subjects or sham rTMS on pharyngeal cortical area in healthy subjects

PlaceborTMS

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • healthy subjects

You may not qualify if:

  • epilepsia
  • brain injury
  • stroke
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VERIN

Rouen, 76031, France

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Eric VERIN, MDPhD

    Rouen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2009

First Posted

June 23, 2014

Study Start

June 1, 2008

Primary Completion

November 1, 2008

Study Completion

June 1, 2009

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations

FR(1)