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Sensory Versus Motor Level Neuromuscular Electrical Stimulation (NMES)

Primary Purpose

Stroke, Ischemic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
Sponsored by
Casa Colina Hospital and Centers for Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Dysphagia, Swallow, Stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-80
  • acute ischemic CVA within the first month and confirmed by MRI.
  • Diagnosis of dysphagia will be obtained by bedside swallowing exam and MBS/FEES studies.

Exclusion Criteria:

  • patients who have contraindications for electrical stimulation (malignancy, DVT/thrombophlebitis, hemorrhagic conditions, pregnancy, pacemaker or other electrical hardware)
  • known premorbid swallowing disorders
  • GERD
  • dementia or psychiatric disorder
  • bilateral cerebral involvement
  • contraindications for FEES/MBS (infectious disease such as HIV, HCV, HBV, nasal obstruction, decompensated heart disease, risk of bleeding such as active ulcers, allergy to contrast).

Sites / Locations

  • Casa Colina Hospital and Centers for Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sensory level stimulation

Motor level stimulation

Arm Description

ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.

ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.

Outcomes

Primary Outcome Measures

Change in Swallow Functional Assessment Measure
7 point swallow scale the Functional oral intake scale (FOIS) lowest score = 1; highest = 7.
Change in Dysphagia outcome Severity Scale
seven-point functional outcome scale designed to assess dysphagia severity on the MBSS, lowest score = 1; highest = 7.

Secondary Outcome Measures

Change in PenAsp
Evaluates the depth response and clearance of material entering into the airway, lowest score = 8; highest =1.
Change in Swal-Qol
93-item outcome tool 24 was used to determine impact on quality-of-life and quality-of-care. Each item has a 5 point likert scale.

Full Information

First Posted
October 12, 2021
Last Updated
August 4, 2022
Sponsor
Casa Colina Hospital and Centers for Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT05102877
Brief Title
Sensory Versus Motor Level Neuromuscular Electrical Stimulation
Acronym
NMES
Official Title
The Effect of Sensory Level Versus Motor Level Electrical Stimulation of Pharyngeal Muscles in Acute Stroke Patients With Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Casa Colina Hospital and Centers for Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support these different modes of stimulation is lacking. This study compared the effectiveness of sensory and motor level stimulation on post-stroke dysphagia.
Detailed Description
Objective: Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support sensory versus motor stimulation is lacking. This study compares the effect of sensory and motor stimulation on post-stroke dysphagia. Design: Randomized controlled trial Setting: Inpatient rehabilitation facility. Participants: Participants (50-75 years of age) who had dysphagia caused by a stroke within 6 months prior to enrollment were included. Participants were excluded if they had a contraindication for electrical stimulation, previous stroke, psychiatric disorder, contraindications for MBS, or pre-stroke swallowing disorders. Interventions: Each patient received ten, 45-minute anterior neck sensory or motor level electrical stimulation sessions in addition to standard speech therapy. Motor stimulation was administered as a stimulus intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin (approximately 4-5mA). Main Outcome Measures: Swallow FIM, National Outcome Measurement System (NOMS), Dysphagia Outcome Severity Scale (DOSS), and change in modified diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Dysphagia, Swallow, Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sensory level stimulation
Arm Type
Experimental
Arm Description
ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.
Arm Title
Motor level stimulation
Arm Type
Experimental
Arm Description
ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
Motor stimulation was administered at an intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin.
Primary Outcome Measure Information:
Title
Change in Swallow Functional Assessment Measure
Description
7 point swallow scale the Functional oral intake scale (FOIS) lowest score = 1; highest = 7.
Time Frame
up to 2 months
Title
Change in Dysphagia outcome Severity Scale
Description
seven-point functional outcome scale designed to assess dysphagia severity on the MBSS, lowest score = 1; highest = 7.
Time Frame
up to 2 months
Secondary Outcome Measure Information:
Title
Change in PenAsp
Description
Evaluates the depth response and clearance of material entering into the airway, lowest score = 8; highest =1.
Time Frame
up to 2 months
Title
Change in Swal-Qol
Description
93-item outcome tool 24 was used to determine impact on quality-of-life and quality-of-care. Each item has a 5 point likert scale.
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-80 acute ischemic CVA within the first month and confirmed by MRI. Diagnosis of dysphagia will be obtained by bedside swallowing exam and MBS/FEES studies. Exclusion Criteria: patients who have contraindications for electrical stimulation (malignancy, DVT/thrombophlebitis, hemorrhagic conditions, pregnancy, pacemaker or other electrical hardware) known premorbid swallowing disorders GERD dementia or psychiatric disorder bilateral cerebral involvement contraindications for FEES/MBS (infectious disease such as HIV, HCV, HBV, nasal obstruction, decompensated heart disease, risk of bleeding such as active ulcers, allergy to contrast).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily R. Rosario, PhD
Organizational Affiliation
Casa Colina Hospital and Centers for Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Casa Colina Hospital and Centers for Healthcare
City
Pomona
State/Province
California
ZIP/Postal Code
91769
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Sensory Versus Motor Level Neuromuscular Electrical Stimulation

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