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

The Hospital for Sick Children

Status and phase

Completed

Phase 2

Conditions

Dysphagia

Treatments

Device: Neuromuscular electrical stimulation (NMES)

Study type

Interventional

Funder types

Other

Identifiers

NCT01723358

1000020206

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

2 weeks to 12 months old

Volunteers

No Healthy Volunteers

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.