NMES: Sensory Versus Motor Level Neuromuscular Electrical Stimulation

Sponsor
Casa Colina Hospital and Centers for Healthcare (Other)
Overall Status
Completed
CT.gov ID
NCT05102877
Collaborator
(none)
31
1
2
26.4
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Neuromuscular electrical stimulation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized trialRandomized trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind
Primary Purpose:
Treatment
Official Title:
The Effect of Sensory Level Versus Motor Level Electrical Stimulation of Pharyngeal Muscles in Acute Stroke Patients With Dysphagia
Actual Study Start Date :
Sep 19, 2018
Actual Primary Completion Date :
Oct 30, 2020
Actual Study Completion Date :
Nov 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Swallow Functional Assessment Measure [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 [up to 2 months]

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

Secondary Outcome Measures

  1. Change in PenAsp [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Casa Colina Hospital and Centers for Healthcare Pomona California United States 91769

Sponsors and Collaborators

  • Casa Colina Hospital and Centers for Healthcare

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emily Rosario, Director of Research, Casa Colina Hospital and Centers for Healthcare
ClinicalTrials.gov Identifier:
NCT05102877
Other Study ID Numbers:
  • NMES 1.1
First Posted:
Nov 2, 2021
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Emily Rosario, Director of Research, Casa Colina Hospital and Centers for Healthcare
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2022