DysphagiaPhase 2NCT06309056
Neuromuscular Electrical Stimulation for Children With Dysphagia
A Phase 2 study testing VitalStim in people with Dysphagia, run by Sir Mortimer B. Davis - Jewish General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 months to 18 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- VitalStim
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Children with neuromuscular diagnoses
- Children with vagal nerve stimulators
- Children with cancerous lesions, inflamed or infected skin or skin eruptions in the treatment area
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating the Effectiveness of Neuromuscular Electrical Stimulation for Children With Dysphagia: A Pilot Study
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).
- Conditions
- Dysphagia
- Being tested
- VitalStim
- Keywords
- neuromuscular electrical stimulation, pediatric dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalStimDevice
VitalStim is a device that provides neuromuscular electrical stimulation. It will be applied on muscles related to swallowing to stimulate muscle contraction.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Not described Receives: Device: VitalStim |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks, 36 weeks
Secondary outcomes (3)
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.
Measured: 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.
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.
Measured: 12 weeks, 36 weeks
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.
Measured: 12 weeks, 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Daniel, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Sam Daniel, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309056
- Sponsor's protocol ID
- MP-05-2024-3903
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: It is undecided.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Neuromuscular Electrical Stimulation for Children With Dysphagia: A Pilot Study
- ClinicalTrials.gov ID
- NCT06309056
- Acronym / sponsor ID
- MP-05-2024-3903
- Conditions
- Dysphagia
- Keywords
- neuromuscular electrical stimulation, pediatric dysphagia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Device: VitalStim |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitalStimVitalStim is a device that provides neuromuscular electrical stimulation. It will be applied on muscles related to swallowing to stimulate muscle contraction. | Device | Interventional Group |
Primary outcome
Feeding Intake - Functional Oral Intake Scale
Time frame: 12 weeks, 36 weeks
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.
3 secondary outcomes
Penetration and Aspiration Scale
Time frame: 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.
Time frame: 12 weeks, 36 weeks
Body Mass Index (kg/m^2)
Time frame: 12 weeks, 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No. It is undecided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Daniel, MD principal investigator
McGill University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VitalStim in people with Dysphagia, run by Sir Mortimer B. Davis - Jewish General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily Ajit-Roger (4383956492, emily.ajit-roger@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding Intake - Functional Oral Intake Scale (time frame: 12 weeks, 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.