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Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01723358
Recruitment Status : Completed
First Posted : November 7, 2012
Last Update Posted : July 20, 2015
Sponsor:
Information provided by (Responsible Party):
Sanjay Mahant, The Hospital for Sick Children

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dysphagia Device: Neuromuscular electrical stimulation (NMES) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neuromuscular electrical stimulation (NMES) Device: 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 Name: VitalStim® therapy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Feeding ability [ Time Frame: baseline, 2 months and 4 months from enrollment ]
    The feeding ability will be assessed using a clinical exam by an occupational therapist.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723358


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Sanjay Mahant, MD The Hospital for Sick Children, Toronto Canada

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanjay Mahant, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01723358    
Other Study ID Numbers: 1000020206
First Posted: November 7, 2012    Key Record Dates
Last Update Posted: July 20, 2015
Last Verified: July 2015
Keywords provided by Sanjay Mahant, The Hospital for Sick Children:
pediatrics
dysphagia
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases