Neuromodulation With rTMS in Dysphagic Patients With Stroke

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Neuromodulation With rTMS in Dysphagic Patients With Stroke

Conditions
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Transcranial Magnetic Stimulation

Intervention / Treatment
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* Device: repetitive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosis of stroke related dysphagia no concurrent neurodegenerative or dementia history an absence of TMS contraindications. Exclusion Criteria: arrythmia, epilepsy, infection, hyperglycemia, pacemaker or implants, external ventricular drain or ventriculoperitoneal shunt

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real stimulation<br>Real repetitive transcranial magnetic stimulation + swallowing training | Device: repetitive transcranial magnetic stimulation<br>* rTMS<br>|
| Sham Comparator: Sham stimulation<br>Sham repetitive transcranial magnetic stimulation + swallowing training | Device: repetitive transcranial magnetic stimulation<br>* rTMS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcome | 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 | 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 | amplitude and latency measured by cricopharyngeal motor evoked potentials | prior to treatment (baseline), on the next day after the 2 weeks treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, Repetitive Transcranial Magnetic Stimulation, Stroke