Clinical trial NCT05102877: Sensory Versus Motor Level Neuromuscular Electrical Stimulation
Official title: The Effect of Sensory Level Versus Motor Level Electrical Stimulation of Pharyngeal Muscles in Acute Stroke Patients With Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Keywords: Dysphagia
Swallow
Stimulation
Lead sponsor: Casa Colina Hospital and Centers for Healthcare
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change in Swallow Functional Assessment Measure
timeFrame: up to 2 months
measure: Change in Dysphagia outcome Severity Scale
timeFrame: up to 2 months
Secondary outcomes:
measure: Change in PenAsp
timeFrame: up to 2 months
measure: Change in Swal-Qol
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Casa Colina Hospital and Centers for Healthcare
state: California
Study officials:
affiliation: Casa Colina Hospital and Centers for Healthcare
name: Emily R. Rosario, PhD
role: PRINCIPAL_INVESTIGATOR
References: