Neuromodulation With rTMS in Dysphagic Patients With Stroke

The patients with chronic dysphagia secondary to first-ever stroke were randomly assigned to 2 groups: Group A: sham stimulation for 10 minutes , Group B: real rTMS for 10 minutes. rTMS conditioning: daily rTMS 10 min for 10 days. Assessments: 1. videofluoroscopy,2.Functional outcome swallowing scale (3 scales). 3. MEP measurements

Study Overview

Detailed Description

While the reflex component of swallowing depends on swallowing centres in the brainstem, initiation of swallowing is a voluntary action that involves the integrity of motor areas of the cerebral cortex. Oropharyngeal dysphagia occurs in more than 50% of stroke patients. Aspiration pneumonia occurs in up to 20% of acute stroke patients and is a major cause of mortality after discharge. Oropharyngeal dysphagia is both underestimated and underdiagnosed as a cause of major nutritional and respiratory complications in stroke patients. Recently, transcranial magnetic stimulation (TMS) has been used to study the cortical input to swallowing control and has revealed that the topographic representation of esophageal motor function in the human cerebral cortex is bilateral but with consistent interhemispheric asymmetry unrelated to handedness.

In a number of recent studies, poststroke motor and dysphagia performance has been improved after daily treatment sessions with repetitive TMS (rTMS) using an excitatory frequency in patients with hemispheric ischaemic stroke due to occlusion of territories of the middle cerebral artery. Our hypothesis was that rTMS would facilitate dysphagia recovery.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. a diagnosis of stroke related dysphagia
  2. no concurrent neurodegenerative or dementia history
  3. an absence of TMS contraindications.

Exclusion Criteria:

  • arrythmia, epilepsy, infection, hyperglycemia, pacemaker or implants, external ventricular drain or ventriculoperitoneal shunt

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real stimulation
Real repetitive transcranial magnetic stimulation + swallowing training
rTMS
Sham Comparator: Sham stimulation
Sham repetitive transcranial magnetic stimulation + swallowing training
rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional outcome
Time Frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion
points of Australian Therapy Outcome Measures-the Swallowing scale as assessed by a clinical therapist
prior to treatment (baseline), on the next day after the 2 weeks treatment completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
videofluoroscopy
Time Frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion
points of Penetration-Aspiration Scale as assessed by videofluoroscopy
prior to treatment (baseline), on the next day after the 2 weeks treatment completion
cricopharyngeal motor evoked potentials
Time Frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion
amplitude and latency measured by cricopharyngeal motor evoked potentials
prior to treatment (baseline), on the next day after the 2 weeks treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Po-Yi Tsai, Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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