NCT05102877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

2.1 years

First QC Date

October 12, 2021

Last Update Submit

August 4, 2022

Conditions

Stroke, Ischemic

Keywords

DysphagiaSwallowStimulation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Change in PenAsp

    up to 2 months

  • Change in Swal-Qol

    up to 3 months

Study Arms (2)

Sensory level stimulation

EXPERIMENTAL

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

Device: Neuromuscular electrical stimulation

Motor level stimulation

EXPERIMENTAL

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

Device: Neuromuscular electrical stimulation

Interventions

Neuromuscular electrical stimulationDEVICE

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 stimulationSensory level stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casa Colina Hospital and Centers for Healthcare

Pomona, California, 91769, United States

Location

MeSH Terms

Conditions

Ischemic StrokeDeglutition Disorders

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Emily R. Rosario, PhD

    Casa Colina Hospital and Centers for Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

October 12, 2021

First Posted

November 2, 2021

Study Start

September 19, 2018

Primary Completion

October 30, 2020

Study Completion

November 30, 2020

Last Updated

August 8, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)