NCT01723358

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
Last Updated

July 20, 2015

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

November 5, 2012

Last Update Submit

July 17, 2015

Conditions

Dysphagia

Keywords

pediatricsdysphagia

Outcome Measures

Primary Outcomes (1)

  • Effectiveness

    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 Outcomes (7)

  • Resolution of dysphagia

    4 months

  • Feeding ability

    baseline, 2 months and 4 months from enrollment

  • Oral feeding ability and need for tube feeding

    baseline, 2 months, 4 months from enrollment

  • Hospitalizations for lower respiratory tract illness

    4 months

  • Safety and Adverse events

    duration of subjects involvment in the study

  • +2 more secondary outcomes

Study Arms (1)

Neuromuscular electrical stimulation (NMES)

EXPERIMENTAL
Device: Neuromuscular electrical stimulation (NMES)

Interventions

Neuromuscular electrical stimulation (NMES)DEVICE

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.

Also known as: VitalStim® therapy
Neuromuscular electrical stimulation (NMES)

Eligibility Criteria

Age2 Weeks - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • Marcus S, Friedman JN, Lacombe-Duncan A, Mahant S. Neuromuscular electrical stimulation for treatment of dysphagia in infants and young children with neurological impairment: a prospective pilot study. BMJ Paediatr Open. 2019 Jan 23;3(1):e000382. doi: 10.1136/bmjpo-2018-000382. eCollection 2019.

    PMID: 30740545DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Sanjay Mahant, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 7, 2012

Study Start

September 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 20, 2015

Record last verified: 2015-07

Locations

CA(1)