Sensory Versus Motor Level Neuromuscular Electrical Stimulation

NCT ID: NCT05102877

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-19
• Study Completion Date: 2020-11-30

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.

Conditions

Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sensory level stimulation

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

Group Type: EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type: 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.

Motor level stimulation

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

Group Type: EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Casa Colina Hospital and Centers for Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Emily Rosario

Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily R. Rosario, PhD

Role: PRINCIPAL_INVESTIGATOR

Casa Colina Hospital and Centers for Healthcare

Locations

Casa Colina Hospital and Centers for Healthcare

Pomona, California, United States

Countries

United States

Other Identifiers

NMES 1.1

Identifier Type: -

Identifier Source: org_study_id