NCT01081444

Brief Summary

The aim of this study is to assess if rTMS on healthy hemisphere at one hertz could improve patients with post stroke dysphagia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2009

Typical duration for phase_4

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

March 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

March 23, 2012

Status Verified

March 1, 2012

Enrollment Period

2.1 years

First QC Date

August 14, 2009

Last Update Submit

March 22, 2012

Conditions

DysphagiaStroke

Keywords

repetitive transcranial stimulation

Outcome Measures

Primary Outcomes (1)

  • Videofluoroscopy and high resolution manometry

    day 0, day 14, day 30, day45

Study Arms (2)

1

ACTIVE COMPARATOR

Active rTMS

Device: rTMS

2

PLACEBO COMPARATOR

sham rTMS

Device: Placebo rTMS

Interventions

rTMSDEVICE

effective and active cortical magnetic stimulations

1
Placebo rTMSDEVICE

non active cortical magnetic stimulation

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • dysphagia
  • first episode of stroke

You may not qualify if:

  • swallowing disorder before stroke
  • previous episode of stroke
  • MMS \< 20 no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiology, Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Deglutition DisordersStroke

Condition Hierarchy (Ancestors)

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

Study Officials

  • Eric VERIN, MD-PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2009

First Posted

March 5, 2010

Study Start

March 1, 2009

Primary Completion

April 1, 2011

Study Completion

October 1, 2011

Last Updated

March 23, 2012

Record last verified: 2012-03

Locations

FR(1)