Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Dysphagia

In brief

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.

Key facts

Study ID

NCT01279824

Run by

University of Florida

People needed

53

Starts

2008-04-01

Expected to finish

2011-04-01

Last updated by the study team

2012-01-05

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Siskin Hospital for Physical Rehabilitation — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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