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

NCT01723358 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-07-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Sanjay Mahant, MD · The Hospital for Sick Children, Toronto Canada

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Weeks
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01723358 on ClinicalTrials.gov