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Not yet recruitingNCT06309056Updated Mar 13, 2024

Neuromuscular Electrical Stimulation for Children With Dysphagia

A Phase 2 interventional study of VitalStim in Dysphagia, sponsored by Sir Mortimer B. Davis - Jewish General Hospital. Not yet recruiting. Open to participants aged 18 Months to 18 Years. Per ClinicalTrials.gov, last updated 2024-03-13.

Sponsored by Sir Mortimer B. Davis - Jewish General Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Months to 18 Years
Sex
All
01

Study 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.

Read the detailed description

The proposed study will consist of a sample size of 10 to 20 children over 18 months diagnosed with oropharyngeal dysphagia, as confirmed by fiberoptic endoscopic evaluation of swallowing (FEES) or videofluoroscopic swallowing study (VFSS). Participants will be recruited at the Lethbridge-Layton-Mackay Rehabilitation Centre Salivation Management Clinic and the Dysphagia and Feeding Disturbance Clinic.

The sample size is based on the number of children who are followed at this clinic who would likely meet the inclusion criteria for this study. It is also based on the availability of human resources.

Participants will be recruited at the Lethbridge-Layton-Mackay Rehabilitation Centre Salivation Management Clinic and the Dysphagia and Feeding Disturbance Clinic. Any instrumental swallowing examination performed up to one year before initiating interventions, at any point during the study, and up to one year following the completion of the interventions, will be retrieved.

VitalStim pediatric electrodes will be placed depending on the impairment causing the child's dysphagia. Electrodes will only be placed on intact skin. No current channels will be placed on a surgical incision or through indwelling foreign material such as tracheostomy, staples or sutures. Current will be applied at the highest tolerated intensity, between 2-25 milliamps. As per the individualized nature of this intervention, the intensity will be individualized per patient and per session. A therapeutic intensity range will be determined by assessing for two or more of the following signs: a change in the audible quality of swallow, description of grabbing/pulling, triggered swallowing, better swallowing than without NMES as evaluated by the clinician (stronger muscles involved in swallowing by palpation, decrease in drooling, improved lip closure, decreased signs of aspiration, ability to swallow a higher quantity of food, ability to swallow food of better consistency), sitting up straight, reaching for electrodes or change of voice. The other parameters will be based on the VitalStim protocol: frequency 80 pps, phase duration 300 microseconds and duty cycle 57:1.

Each session will last up to 45 minutes, as tolerated by the child, twice weekly, for three months. The overall duration of the study will last nine months. For the first three months, the participant will receive the intervention twice a week. There will then be a final follow-up meeting six months after the final intervention. There will be a total of 25 sessions. At the first session, participants and their parent/caregiver will complete four questionnaires evaluating the child's feeding ability, the child's drooling, the child's overall quality of life and the impact and stress that feeding difficulties have on the child's parent. Each questionnaire will take approximately 5 minutes to complete. If the child has a developmental age of 4 or below, the parent/caregiver will complete all the questionnaires. If the child has a developmental age of 5 or older, they will complete one questionnaire by themselves, and the others will be completed by the parent/caregiver. Also, the child will be measured and weighed. These parameters will be repeated at the final intervention session (week 12) and six months later (week 36).

02

Conditions studied

  • Dysphagia

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Keywords

  • neuromuscular electrical stimulation
  • pediatric dysphagia
03

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's planned enrollment of 10 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital is the lead sponsor of 61 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Interventional Group

    Device: VitalStim

  • No intervention
    Control Group

Interventions

  • DeviceVitalStim

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

06

What researchers measure

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.

    Time frame: 12 weeks, 36 weeks

Secondary outcomes

  1. Penetration and Aspiration Scale

    Penetration and aspiration will be assessed using functional endoscopic swallowing studies or videofluoroscopic swallowing studies, if available as part of the participant's regular treatment. This scale is scored from 0 to 8. A lower score indicates a better outcome.

    Time frame: 12 weeks, 36 weeks

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

    The quality of life of children will be assessed using the Pediatric Quality of Life Inventory using the form specific to the age of the participant. The score is from 0 to 84 (toddlers), 0 to 92 (young children), 0 to 92 (children 8-12) and 0 to 60 (teenagers). A lower score indicates a better outcome.

    Time frame: 12 weeks, 36 weeks

  3. Body Mass Index (kg/m^2)

    Height in m\^2 and weight in kilograms will be obtained to measure the body mass index. A higher score indicates a better outcome.

    Time frame: 12 weeks, 36 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — It is undecided.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06309056
Lead sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Responsible party
Sam Daniel (Pediatric Otolaryngologist, Sir Mortimer B. Davis - Jewish General Hospital) — Principal investigator
First posted
Mar 13, 2024
Start date
Mar 2024 (estimated)
Primary completion
Mar 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
Mar 13, 2024

Study contacts

Emily Ajit-Roger
Contact
emily.ajit-roger@mail.mcgill.ca
4383956492
Sam Daniel, MD
principal investigator · McGill University

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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