Sensory Versus Motor Level Neuromuscular Electrical Stimulation

Stroke, Ischemic Clinical Trial

— NMES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05102877
• Other study ID #: NMES 1.1
• Status: Completed
• Phase: N/A
• Start date: September 19, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: August 2022
• Source: Casa Colina Hospital and Centers for Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke, Ischemic

Intervention

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.

Locations

Country	Name	City	State
United States	Casa Colina Hospital and Centers for Healthcare	Pomona	California

Sponsors (1)

Lead Sponsor	Collaborator
Casa Colina Hospital and Centers for Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Swallow Functional Assessment Measure	7 point swallow scale the Functional oral intake scale (FOIS) lowest score = 1; highest = 7.	up to 2 months
Primary	Change in Dysphagia outcome Severity Scale	seven-point functional outcome scale designed to assess dysphagia severity on the MBSS, lowest score = 1; highest = 7.	up to 2 months
Secondary	Change in PenAsp	Evaluates the depth response and clearance of material entering into the airway, lowest score = 8; highest =1.	up to 2 months
Secondary	Change in Swal-Qol	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.	up to 3 months