Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing

NCT01279824 | Completed Phase 2 DMC

• 1 other identifier: R21HD054752
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Keywords

swallowing, treatment, stroke,rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Recovery of pre-stroke diet

  Baseline, 3 weeks (post treatment) and 3 months post

• Dysphagia-related medical complications

  Baseline,3 weeks ( post treatment) and 3 months post

• Biomechanic evaluation of swallowing function

  Baseline and 3 weeks (post treatment)

• Functional stroke recovery

  Baseline, 3 weeks (post treatment) and at 3-months post treatment

• Neurological status/Stroke severity

  baseline, 3 weeks (post treatment) and at the 3-month post treatment

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

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

sham NMES

PLACEBO COMPARATOR

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

NMES therapy

EXPERIMENTAL

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

Interventions

swallowing therapy BEHAVIORAL

Standardized behavioral swallowing intervention

NMES therapy; Usual Care; sham NMES

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Florida: lead
• National Center for Medical Rehabilitation Research (NCMRR): collaborator

Study Sites (1)

Siskin Hospital for Physical Rehabilitation

Chattanooga, Tennessee, 37403, United States

Location

Related 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. doi: 10.1177/000348940811700407.

  PMID: 18478837 BACKGROUND

• 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.

  PMID: 17576907 BACKGROUND

• 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.

  PMID: 20434612 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Giselle Carnaby-Mann, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 19, 2011
• Study Start: April 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 5, 2012

Record last verified: 2011-01

Locations

US (1)