Sensory Versus Motor Level Neuromuscular Electrical Stimulation

Study Overview
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Brief Summary
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Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support these different modes of stimulation is lacking. This study compared the effectiveness of sensory and motor level stimulation on post-stroke dysphagia.

Detailed Description
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Objective: Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support sensory versus motor stimulation is lacking. This study compares the effect of sensory and motor stimulation on post-stroke dysphagia. Design: Randomized controlled trial Setting: Inpatient rehabilitation facility. Participants: Participants (50-75 years of age) who had dysphagia caused by a stroke within 6 months prior to enrollment were included. Participants were excluded if they had a contraindication for electrical stimulation, previous stroke, psychiatric disorder, contraindications for MBS, or pre-stroke swallowing disorders. Interventions: Each patient received ten, 45-minute anterior neck sensory or motor level electrical stimulation sessions in addition to standard speech therapy. Motor stimulation was administered as a stimulus intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin (approximately 4-5mA). Main Outcome Measures: Swallow FIM, National Outcome Measurement System (NOMS), Dysphagia Outcome Severity Scale (DOSS), and change in modified diet.

Official Title
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The Effect of Sensory Level Versus Motor Level Electrical Stimulation of Pharyngeal Muscles in Acute Stroke Patients With Dysphagia

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Device: Neuromuscular electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 acute ischemic CVA within the first month and confirmed by MRI. Diagnosis of dysphagia will be obtained by bedside swallowing exam and MBS/FEES studies. Exclusion Criteria: patients who have contraindications for electrical stimulation (malignancy, DVT/thrombophlebitis, hemorrhagic conditions, pregnancy, pacemaker or other electrical hardware) known premorbid swallowing disorders GERD dementia or psychiatric disorder bilateral cerebral involvement contraindications for FEES/MBS (infectious disease such as HIV, HCV, HBV, nasal obstruction, decompensated heart disease, risk of bleeding such as active ulcers, allergy to contrast).

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Randomized trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensory level stimulation<br>ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy. | Device: Neuromuscular electrical stimulation<br>* Motor stimulation was administered at an intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin.<br>|
| Experimental: Motor level stimulation<br>ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy. | Device: Neuromuscular electrical stimulation<br>* Motor stimulation was administered at an intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Swallow Functional Assessment Measure | 7 point swallow scale the Functional oral intake scale (FOIS) lowest score = 1; highest = 7. | up to 2 months | 
| Change in Dysphagia outcome Severity Scale | seven-point functional outcome scale designed to assess dysphagia severity on the MBSS, lowest score = 1; highest = 7. | up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PenAsp | Evaluates the depth response and clearance of material entering into the airway, lowest score = 8; highest =1. | up to 2 months | 
| Change in Swal-Qol | 93-item outcome tool 24 was used to determine impact on quality-of-life and quality-of-care. Each item has a 5 point likert scale. | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, Swallow, Stimulation