Repetitive Transcranial Stimulation (rTMS) in Post Stroke Dysphagia

NCT ID: NCT01081444

Last Updated: 2012-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-10-31

Brief Summary

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

Detailed Description

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Conditions

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Dysphagia Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Active rTMS

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type DEVICE

effective and active cortical magnetic stimulations

2

sham rTMS

Group Type PLACEBO_COMPARATOR

Placebo rTMS

Intervention Type DEVICE

non active cortical magnetic stimulation

Interventions

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rTMS

effective and active cortical magnetic stimulations

Intervention Type DEVICE

Placebo rTMS

non active cortical magnetic stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* dysphagia
* first episode of stroke

Exclusion Criteria

* swallowing disorder before stroke
* previous episode of stroke
* MMS \< 20 no consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric VERIN, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Physiology, Rouen University Hospital

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2007/122/HP

Identifier Type: -

Identifier Source: org_study_id

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