Neuromuscular Electrical Stimulation for Children With Dysphagia

NCT06309056 | Not Yet Recruiting Phase 2 FDA Device

• 1 other identifier: MP-05-2024-3903
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to measure if using neuromuscular electrical stimulation (NMES) effectively improves swallowing, drooling (if applicable), feeding ability, physical growth and quality of life in children with severe dysphagia. This pilot study is for children aged over 18 months old with dysphagia. It aims to investigate a new approach to help children improve their swallowing function. Some published studies have shown that electrical stimulation to muscles involved in swallowing may help children with dysphagia. In this pilot study, NMES will be used. This procedure delivers electrical stimulation to make participants' muscles contract. Electrodes are placed on the skin, over the muscles that help with swallowing, and an electric current is delivered through wires which are connected to a small machine. The current is controlled through a small, handheld device. NMES will be applied to muscles involved in eating, drinking and swallowing. NMES will be applied to the participant alongside their regular treatment. No medications or treatments will be added, modified or discontinued as part of this study. The overall duration of the study per participant will last a total of nine months. For the first three months, the participant will receive the NMES twice a week. There will be no interventions or follow-up appointments scheduled for the following 6 months. Then, there will be a final follow-up meeting 9 months following the start of the intervention to evaluate for lasting changes.

Conditions

Dysphagia

Keywords

neuromuscular electrical stimulation; pediatric dysphagia

Outcome Measures

Primary Outcomes (1)

• Feeding Intake - Functional Oral Intake Scale

  Feeding intake will be assessed using the Functional Oral Intake Scale. This scale assesses one's ability to tolerate oral intake of various consistencies. This scale is scored from 0 to 7. A higher score indicates a better outcome.

  12 weeks, 36 weeks

Secondary Outcomes (3)

• Penetration and Aspiration Scale

  12 weeks, 36 weeks

• Quality of Life - Pediatric Quality of Life Inventory 4.0 Generic Core Scale for Toddlers, Young Children, Children 8-12 years old OR Teenagers.

  12 weeks, 36 weeks

• Body Mass Index (kg/m^2)

  12 weeks, 36 weeks

Study Arms (2)

Interventional Group

EXPERIMENTAL

Device: VitalStim

Control Group

NO INTERVENTION

Interventions

VitalStim DEVICE

VitalStim is a device that provides neuromuscular electrical stimulation. It will be applied on muscles related to swallowing to stimulate muscle contraction.

Interventional Group

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with oropharyngeal dysphagia
• Children aged over 18 months
• Children with the ability to swallow
• Children and their caregiver(s) have a good cooperation and motivation
• Families are able and willing to participate in the study
• Children and their families understand and communicate in English or French

You may not qualify if:

• Children with esophageal dysphagia
• Children without dysphagia
• Children who are unable to swallow or who are unaware of having liquid/food in their mouths
• Children with solely anatomical etiologies of dysphagia such as obstructing tumors
• Children aged less than 18 months, and adults 18 years of age and older
• Children and their families do not communicate in English or French
• Children with neuromuscular diagnoses
• Children with vagal nerve stimulators
• Children with cancerous lesions, inflamed or infected skin or skin eruptions in the treatment area

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Sam Daniel, MD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Ajit-Roger

CONTACT

4383956492; emily.ajit-roger@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Otolaryngologist

Model Details: Patients being followed at the Lethbridge-Layton-Mackay Rehabilitation Centre Salivation Management Clinic and the Dysphagia and Feeding Disturbance Clinic who meet inclusion criteria will be recruited. If caregivers/participants consent to the study, they will be enrolled in the intervention arm. Any potentially eligible participant who declines to participate in the study will be recruited as a control group. These participants will complete the questionnaires at the same timepoints as the interventional group and data from the medical charts will be included in the study.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 13, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share