Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06309056 |
| Other study ID # |
MP-05-2024-3903 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
March 2024 |
| Est. completion date |
March 2026 |
Study information
| Verified date |
March 2024 |
| Source |
Sir Mortimer B. Davis - Jewish General Hospital |
| Contact |
Emily Ajit-Roger |
| Phone |
4383956492 |
| Email |
emily.ajit-roger[@]mail.mcgill.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
