Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing

Study Overview
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Brief Summary
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Neuromuscular Electrical stimulation (NMES) for swallowing has recently been proposed for the treatment of dysphagia post stroke and is clinically receiving favor as a treatment modality, in the absence of strong research support. This study aims to investigate the effect of NMES therapy for dysphagia upon recovery of swallowing function following stroke. The study will follow a pilot randomized controlled trial design. Fifty one patients admitted to a sub-acute rehabilitation facility will be clinically screened for dysphagia, and randomized into one of three groups, NMES, sham NMES or usual care -behavioral swallowing therapy arm. All patients will be treated for one hour per day for 3 weeks, and their progress and outcome will be monitored. The results will add to the preliminary data on the effectiveness of this form of swallowing treatment for patients following stroke, and has the potential to enable more efficient allocation of resources to post-acute rehabilitation and thus benefit afforded to stroke patients, and the community.

Detailed Description
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This pilot randomized controlled trial (N=51) includes stroke patients admitted to a sub-acute rehabilitation facility. Subjects will be clinically screened for dysphagia, and randomized into three groups, NMES, sham NMES or usual care -behavioral swallowing therapy arm. Following randomization, all subjects will undergo a video-x-ray (modified barium swallow) of swallowing to confirm the presence of oropharyngeal dysphagia and provide objective data about the nature and degree of dysphagia. All patients will be treated for one hour per day for 3 weeks, and their progress and outcome will be recorded. Participants will be independently evaluated by a blinded assessor at baseline, post treatment and at 3 months following treatment. The primary outcome will be improvement in clinical swallowing ability, oral intake level, and body weight. The results will add to the preliminary data on the effectiveness of this form of swallowing treatment for patients following stroke.

Official Title
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A Randomized Controlled Trial of NMES vs. Traditional Dysphagia Therapy After Stroke

Conditions
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Dysphagia

Intervention / Treatment
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* Behavioral: swallowing therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stroke identified by neurological and radiological examination Oropharyngeal dysphagia as confirmed by clinical and radiological examination No prior history of oropharyngeal dysphagia by patient and/or caregiver report No previous head/neck surgery or trauma that may impact swallowing ability No other/concomitant neurological disorders (e.g. Parkinson's disease) that would impact oropharyngeal swallowing ability. This does not include post-stroke deficits. Physician and patient/family agreement to participate. Exclusion Criteria: Exposed to previous behavioral or NMES swallowing therapy within 6 months of admission Presence of progressive neurological disorder, such as ALS; Parkinson's or other neurologic disorders within the last 6 months; History of neurosurgery (either ablative or stimulatory), encephalitis or significant head trauma. History of a significant medical condition such as heart, liver, or renal disease; history or evidence of malignancy within the past 5 years other than excised basal cell carcinoma. Because of FDA Warnings, patients with cardiac demand pace makers will be excluded. Patients with evidence of significant cognitive impairment or dementia as reflected in a Mini-Mental test less than 23 and/or a score of 50% or less on the comprehension quotient on the Western Aphasia Battery.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 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: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Patients will receive behavioral swallowing therapy comprising combination's of treatment strategies / exercises chosen from an approved hierarchy. This formulation of treatment will be designed and applied by the treating clinician.The treatment will be provided daily for a one-hour over a consecutive 3-week period. | Behavioral: swallowing therapy<br>* Standardized behavioral swallowing intervention<br>|
| Placebo Comparator: sham NMES<br>Patients will receive behavioral swallowing therapy comprising combinations of treatment strategies / exercises chosen from an approved hierarchy with the addition of non stimulating electrodes. A faux NMES device will be utilized with an active current display and non stimulating electrodes. The treatment will be provided daily for a one-hour over a consecutive 3-week period. | Behavioral: swallowing therapy<br>* Standardized behavioral swallowing intervention<br>|
| Experimental: NMES therapy<br>Patients will receive a protocol of standardized behavioral swallowing intervention combined with NMES. This formulation of treatment will be prescribed from a standard protocol and will be applied daily for one-hour over a consecutive 3-week period. | Behavioral: swallowing therapy<br>* Standardized behavioral swallowing intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | Mann Assessment of Swallowing Ability (M.A.S.A)and Functional Oral Intake Scale (F.O.I.S) change, without significant weight loss or dysphagia-related complication | 3 weeks post treatment | 
| Full clinical response | Mann Assessment of Swallowing Ability (M.A.S.A)and Functional Oral Intake Scale (F.O.I.S) change, without significant weight loss or dysphagia-related complication. | 3 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of pre-stroke diet | comparison of diet intake | Baseline, 3 weeks (post treatment) and 3 months post | 
| Dysphagia-related medical complications | Occurance of chest infection, dehydration or significant weight loss | Baseline,3 weeks ( post treatment) and 3 months post | 
| Biomechanic evaluation of swallowing function | Modified barium swallow measurement will be used to document changes in swallowing biomechanics associated with change in swallowing following treatment. | Baseline and 3 weeks (post treatment) | 
| Functional stroke recovery | Modified Rankin Scale and the Modified Barthel Index will be used to measure functional stroke recovery. | Baseline, 3 weeks (post treatment) and at 3-months post treatment | 
| Neurological status/Stroke severity | National Institutes of Health Stroke Scale will be used to measure neurological status change. | baseline, 3 weeks (post treatment) and at the 3-month post treatment | 
| Patient perception of swallowing ability | Using a visual analogue scale patients will indicate ability to swallow. | baseline, 3 weeks (post treatment) and at 3-months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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swallowing, treatment, stroke,rehabilitation