Sensory Versus Motor Level Neuromuscular Electrical Stimulation

Not Applicable

Completed

• Conditions: Stroke, Ischemic
• Interventions: Device: Neuromuscular electrical stimulation

• Registration Number: NCT05102877
• Lead Sponsor: Casa Colina Hospital and Centers for Healthcare

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.

Study Timeline

• Study Start: 2018-09-19
• Primary Completion: 2020-10-30
• Study Completion: 2020-11-30
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-11-02
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sensory level stimulation	Neuromuscular electrical stimulation	ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.
Motor level stimulation	Neuromuscular electrical stimulation	ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Casa Colina Hospital and Centers for Healthcare; 🇺🇸 Pomona, California, United States