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Completed

NCT Number: NCT05102877

Sensory Versus Motor Level Neuromuscular Electrical Stimulation

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Ischemic Stroke Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Casa Colina Hospital and Centers for Healthcare

Pomona, California, 91769, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

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 outcomes

  1. Change in Swallow Functional Assessment Measure

    Time frame: up to 2 months

    7 point swallow scale the Functional oral intake scale (FOIS) lowest score = 1; highest = 7.

  2. Change in Dysphagia outcome Severity Scale

    Time frame: up to 2 months

    seven-point functional outcome scale designed to assess dysphagia severity on the MBSS, lowest score = 1; highest = 7.

Secondary outcomes

  1. Change in PenAsp

    Time frame: up to 2 months

    Evaluates the depth response and clearance of material entering into the airway, lowest score = 8; highest =1.

  2. Change in Swal-Qol

    Time frame: up to 3 months

    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.

Sponsors and collaborators

Lead sponsor

Casa Colina Hospital and Centers for Healthcare

Other

Registry information

Official study title

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

Acronym: NMES

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 2, 2021
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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