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Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing (ANSRS)

Primary Purpose

Dysphagia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

swallowing therapy

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring swallowing, treatment, stroke,rehabilitation

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Siskin Hospital for Physical Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Usual Care

sham NMES

NMES therapy

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Recovery of pre-stroke diet

comparison of diet intake

Dysphagia-related medical complications

Occurance of chest infection, dehydration or significant weight loss

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.

Functional stroke recovery

Modified Rankin Scale and the Modified Barthel Index will be used to measure functional stroke recovery.

Neurological status/Stroke severity

National Institutes of Health Stroke Scale will be used to measure neurological status change.

Patient perception of swallowing ability

Using a visual analogue scale patients will indicate ability to swallow.

Full Information

NCT ID

NCT01279824

First Posted

January 7, 2011

Last Updated

January 4, 2012

Sponsor

University of Florida

Collaborators

National Center for Medical Rehabilitation Research (NCMRR)

1. Study Identification

Unique Protocol Identification Number

NCT01279824

Brief Title

Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing

Acronym

ANSRS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

National Center for Medical Rehabilitation Research (NCMRR)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysphagia

Keywords

swallowing, treatment, stroke,rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care

Arm Type

Active Comparator

Arm Description

Arm Title

sham NMES

Arm Type

Placebo Comparator

Arm Description

Arm Title

NMES therapy

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

swallowing therapy

Intervention Description

Standardized behavioral swallowing intervention

Primary Outcome Measure Information:

Title

Clinical response

Description

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

Time Frame

3 weeks post treatment

Title

Full clinical response

Description

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.

Time Frame

3 months post treatment

Secondary Outcome Measure Information:

Title

Recovery of pre-stroke diet

Description

comparison of diet intake

Time Frame

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

Title

Dysphagia-related medical complications

Description

Occurance of chest infection, dehydration or significant weight loss

Time Frame

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

Title

Biomechanic evaluation of swallowing function

Description

Modified barium swallow measurement will be used to document changes in swallowing biomechanics associated with change in swallowing following treatment.

Time Frame

Baseline and 3 weeks (post treatment)

Title

Functional stroke recovery

Description

Modified Rankin Scale and the Modified Barthel Index will be used to measure functional stroke recovery.

Time Frame

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

Title

Neurological status/Stroke severity

Description

National Institutes of Health Stroke Scale will be used to measure neurological status change.

Time Frame

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

Title

Patient perception of swallowing ability

Description

Using a visual analogue scale patients will indicate ability to swallow.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giselle Carnaby-Mann, PhD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siskin Hospital for Physical Rehabilitation

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37403

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18478837

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.

Results Reference

background

PubMed Identifier

17576907

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.

Results Reference

background

PubMed Identifier

20434612

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.

Results Reference

background

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Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing

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