Clinical trial NCT01279824: Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing
Official title: A Randomized Controlled Trial of NMES vs. Traditional Dysphagia Therapy After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dysphagia
Keywords: swallowing, treatment, stroke,rehabilitation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Center for Medical Rehabilitation Research (NCMRR)
First posted: 2011-01-19
Enrollment: 53
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical response
timeFrame: 3 weeks post treatment
measure: Full clinical response
timeFrame: 3 months post treatment
Secondary outcomes:
measure: Recovery of pre-stroke diet
timeFrame: Baseline, 3 weeks (post treatment) and 3 months post
measure: Dysphagia-related medical complications
timeFrame: Baseline,3 weeks ( post treatment) and 3 months post
measure: Biomechanic evaluation of swallowing function
timeFrame: Baseline and 3 weeks (post treatment)
measure: Functional stroke recovery
timeFrame: Baseline, 3 weeks (post treatment) and at 3-months post treatment
measure: Neurological status/Stroke severity
timeFrame: baseline, 3 weeks (post treatment) and at the 3-month post treatment
measure: Patient perception of swallowing ability
timeFrame: baseline, 3 weeks (post treatment) and at 3-months post treatment
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Siskin Hospital for Physical Rehabilitation
state: Tennessee
Study officials:
affiliation: University of Florida
name: Giselle Carnaby-Mann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carnaby-Mann GD, Crary MA. Adjunctive neuromuscular electrical stimulation for treatment-refractory dysphagia. Ann Otol Rhinol Laryngol. 2008 Apr;117(4):279-87. doi: 10.1177/000348940811700407.
citation: Carnaby-Mann GD, Crary MA. Examining the evidence on neuromuscular electrical stimulation for swallowing: a meta-analysis. Arch Otolaryngol Head Neck Surg. 2007 Jun;133(6):564-71. doi: 10.1001/archotol.133.6.564.
citation: Carnaby-Mann GD, Crary MA. McNeill dysphagia therapy program: a case-control study. Arch Phys Med Rehabil. 2010 May;91(5):743-9. doi: 10.1016/j.apmr.2010.01.013.