Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing

Dysphagia Clinical Trial

— ANSRS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279824
• Other study ID #: R21HD054752
• Secondary ID: R21HD054752
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 7, 2011
• Last updated: January 4, 2012
• Start date: April 2008
• Est. completion date: April 2011

Study information

• Verified date: January 2011
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Behavioral:
• swallowing therapy
Standardized behavioral swallowing intervention

Locations

Country	Name	City	State
United States	Siskin Hospital for Physical Rehabilitation	Chattanooga	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Center for Medical Rehabilitation Research (NCMRR)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Carnaby-Mann GD, Crary MA. Adjunctive neuromuscular electrical stimulation for treatment-refractory dysphagia. Ann Otol Rhinol Laryngol. 2008 Apr;117(4):279-87. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Recovery of pre-stroke diet	comparison of diet intake	Baseline, 3 weeks (post treatment) and 3 months post	No
Secondary	Dysphagia-related medical complications	Occurance of chest infection, dehydration or significant weight loss	Baseline,3 weeks ( post treatment) and 3 months post	Yes
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No