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Sensory Versus Motor Level Neuromuscular Electrical Stimulation (NMES)

C

Casa Colina Hospital and Centers for Healthcare

Status

Completed

Conditions

Stroke, Ischemic

Treatments

Device: Neuromuscular electrical stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05102877
NMES 1.1

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

31 participants in 2 patient groups

Sensory level stimulation
Experimental group
Description:
ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.
Treatment:
Device: Neuromuscular electrical stimulation
Motor level stimulation
Experimental group
Description:
ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.
Treatment:
Device: Neuromuscular electrical stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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