- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01723358
Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia
July 17, 2015 updated by: Sanjay Mahant, The Hospital for Sick Children
Effectiveness of a New Neuromuscular Electrical Stimulation (NMES) Treatment Technique (VitalStim® Therapy) in the Management of Young Infants With Severe Dysphagia: a Prospective Pilot Study
The goal of this study is to obtain data that well help inform the feasibility and design of a randomized control trial of the therapeutic Neuromuscular Electrical Stimulation (NMES) technique in improving the swallowing function of young infants presenting with severe dysphagia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Infants with severe neurologic disability often have difficulty in eating by mouth due to a disruption in the swallowing process.
This swallowing dysfunction, also known as dysphagia, is often evident early in life and when severe can be permanent.
Dysphagia can lead to an inability to take in enough food to maintain an adequate weight and result in malnutrition.
It also can result in food going into the lungs instead of the stomach, resulting in an illness called aspiration pneumonia.
Both of these complications may require feeding by tube either through the nose into the stomach or directly into the stomach via the abdominal wall, to bypass the swallowing process.
This process is resource intense, can be associated with a number of complications and may result in a reduced quality of life for both the infant and caregivers.
Currently, there are no effective treatments to change the natural course of dysphagia in this context.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 weeks to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Infants with severe dysphagia on VFFS as defined by dysphagia resulting in aspiration with swallow of at least 2 food textures (e.g. thin and thick liquid).
- We will include children with dysphagia due to a central neurologic deficit. The neurologic diagnosis will be based on the diagnosis from the treating physician.
Exclusion Criteria:
- Infants with a known or suspected neurodegenerative or peripheral neuromuscular condition or a medical condition that is a contraindication for NMES treatment (tumours in the neck region and neck soft tissue infections).
- Children with neurodegenerative disorders have been excluded as their natural history of dysphagia would be different from those with a static neurologic disorder.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neuromuscular electrical stimulation (NMES)
|
The intervention will consist of a period of treatment with NMES.
This treatment will involve 20-45 minute feeding therapy sessions during which NMES will be administered by an Occupational Therapist.
Frequency of therapy sessions will be 4 times per week for the first 2 weeks (as in inpatient, if hospitalized) and then biweekly for 14 weeks for a total of 36 sessions (over 16 weeks).
For patients who are discharged prior to the first 2 weeks of treatment, outpatient sessions will be biweekly.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness
Time Frame: 4 months
|
The primary outcome will be an improvement in swallowing function as determined by videofluoroscopic feeding study from baseline to end of treatment (4 months after baseline).
The swallowing function will be graded as to the number of textures the infant can safely swallow at three measurement points (baseline, 2 months and 4 months).
An improvement in the number of textures the infant can swallow will define improvement.
This will be recorded using a standard reporting form.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resolution of dysphagia
Time Frame: 4 months
|
The proportion of children whose dysphagia resolves (i.e.
safe to feed on all consistencies of solids and liquids) at 4 months will be calculated.
|
4 months
|
Feeding ability
Time Frame: baseline, 2 months and 4 months from enrollment
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The feeding ability will be assessed using a clinical exam by an occupational therapist.
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baseline, 2 months and 4 months from enrollment
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Oral feeding ability and need for tube feeding
Time Frame: baseline, 2 months, 4 months from enrollment
|
Oral feeding ability and the need for tube feeding will be assessed using a structured scale based on parental report of dietary intake that includes: Level 1: Nothing by mouth, all nutrition by tube feeds, Level 2: <50% intake by mouth, tube feeding requirement, Level 3: >50% intake by mouth, tube feeding, requirement, Level 4: All by mouth, no tube feeding.
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baseline, 2 months, 4 months from enrollment
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Hospitalizations for lower respiratory tract illness
Time Frame: 4 months
|
The frequency of hospitalizations for lower respiratory tract illnesses in the 4 months following enrollment into the study will be determined by administering a structured questionnaire to parents.
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4 months
|
Safety and Adverse events
Time Frame: duration of subjects involvment in the study
|
Data collection of adverse events will occur through administration of a structured questionnaire by the occupational therapist at the end of each treatment session and just prior to the subsequent session.
|
duration of subjects involvment in the study
|
Caregiver acceptability and perception of feeding
Time Frame: at 4 months
|
Two questions using a 10 cm visual analogue scale will ask whether parents were satisfied with the treatment process and whether the caregiver felt that their child's feeding ability improved during treatment.
Two further open ended questions will probe what aspects of the treatment they felt were positive and what aspects they felt were negative.
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at 4 months
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Data on treatment procedures
Time Frame: 4 months
|
Data will be collected by the occupational therapist after each treatment session.
This will include method of feeding, amount of food taken, response to treatment, length of treatment session, location of electrode placement and amplitude of stimulation used.
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4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sanjay Mahant, MD, The Hospital for Sick Children, Toronto Canada
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
November 5, 2012
First Submitted That Met QC Criteria
November 5, 2012
First Posted (Estimate)
November 7, 2012
Study Record Updates
Last Update Posted (Estimate)
July 20, 2015
Last Update Submitted That Met QC Criteria
July 17, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000020206
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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