Sensory Versus Motor Level Neuromuscular Electrical Stimulation (NMES)

The Effect of Sensory Level Versus Motor Level Electrical Stimulation of Pharyngeal Muscles in Acute Stroke Patients With Dysphagia

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Device: Neuromuscular electrical stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pomona, California, United States, 91769
      • Casa Colina Hospital and Centers for Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sensory level stimulation; ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.	Device: Neuromuscular electrical stimulation; 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.
EXPERIMENTAL: Motor level stimulation; ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.	Device: Neuromuscular electrical stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Swallow Functional Assessment Measure	7 point swallow scale the Functional oral intake scale (FOIS) lowest score = 1; highest = 7.	up to 2 months
Change in Dysphagia outcome Severity Scale	seven-point functional outcome scale designed to assess dysphagia severity on the MBSS, lowest score = 1; highest = 7.	up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PenAsp	Evaluates the depth response and clearance of material entering into the airway, lowest score = 8; highest =1.	up to 2 months
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.	up to 3 months

Collaborators and Investigators

• Sponsor: Casa Colina Hospital and Centers for Healthcare
• Investigators: Principal Investigator: Emily R. Rosario, PhD, Casa Colina Hospital and Centers for Healthcare

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 19, 2018
• Primary Completion (ACTUAL): October 30, 2020
• Study Completion (ACTUAL): November 30, 2020

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (ACTUAL): November 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Dysphagia; Swallow; Stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: NMES 1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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