Outcomes of Using LNMES on Tracheostomized Children

Tracheostomy tubes are known to have a negative impact on swallowing. Dysphagia treatment includes using laryngoneuromuscular electrical muscular stimulation (LNMES). Evidence exist on the efficacy of LNMES in the treatment of dysphagia in adults, and scarce in pediatrics. There is no literature available for the efficacy of LNMES in the treatment of dysphagia on patients with tracheostomy tubes. The purpose of this study to determine the outcomes on dysphagia on children with tracheostomy tubes when treated using LNMES. Furthermore, the investigators aim to determine the relationship between parental stress and a child's modified diet.

Study Overview

• Status: Withdrawn
• Conditions: Trachea
• Intervention / Treatment: Device: VitalStim; Other: Traditional Therapy

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

PATIENT COHORT

• Children between 0-4 years 11 months
• Currently have tracheostomy tubes
• MBSS must indicate penetrations of more than 50% of swallows or aspiration of thin, ½ nectar-thick, nectar-thick or honey-thick liquids.
• The child must be on a modified diet of honey-thick liquids, nectar-thick liquids, ½ nectar-thick liquids, or no liquids by mouth.
• Able to tolerate a voice valve PARENT COHORT
• At least one primary caregiver of a qualifying child (see Child cohort).
• Parent/caregiver must be at least 18 years of age or older, provide primary care, and have medical decision making rights for the child.

Exclusion Criteria:

PATIENT COHORT

• Children who are not on modified diets or using a g-tube as an alternate means of nutrition
• Children with suspected or diagnosed heart problems
• Children with suspected or diagnosed epilepsy
• Children with a tendency to hemorrhage following acute trauma or fracture
• Children who have undergone recent surgical procedures when muscle contraction may disrupt the healing process
• Children for whom the LNMES would be: 1) over carotid sinus, 2) over neoplasm, 3) over active infection and 4) over areas of skin which lack normal sensation
• Children with difficulty tolerating tactile stimulation and tolerate the whole duration of the LNMES sessions.
• Children with difficulty tolerating tactile sensory stimulation such as tape and electrodes on the anterior aspect of the neck.

PARENT COHORT

• The caregiver that does not provide the primary care of the child and does not have medical decision making right
• Parents under 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VitalStim; One group of children (Group A) will receive 24 sessions of NMES for combined with traditional therapy including oral motor exercises and laryngeal exercises will be performed to the participants. The equipment to be used for NMES is VitalStim®. VitalStim is a product of Empi®. VitalStim® therapy involves the placement of electrodes to the muscles of the throat that is attached to a device that provides electrical stimulation. The intensity will be increased according to the subject's tolerance and when a "therapeutic" level is reached. Signs of reaching therapeutic level include changes in audible quality of swallows, triggers of swallows, and changes in quality of voice. This therapy is to be performed by a VitalStim® certified practitioner.	Device: VitalStim; One group of children (Group A) will receive 24 sessions of NMES for combined with traditional therapy including oral motor exercises and laryngeal exercises will be performed to the participants. The equipment to be used for NMES is VitalStim®. VitalStim is a product of Empi®.
Active Comparator: Traditional therapy; The other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy.	Other: Traditional Therapy; The other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess Quality of Swallow during the MBSS (Modified Barium Swallow Study) using the Pen-Asp scale.	The investigators will measure the change based on the patient's score of the Pen-Asp scale before and after the intervention provided.	3 months. LNMES intervention will be provided for 24 sessions during this time.
Assess safety and adequate functional oral intake using the FOIS (Functional Oral Intake Scale)	The investigators will measure the change based on the patient's score of the FOIS before and after the intervention provided.	3 months. LNMES intervention will be provided for 24 sessions during this time.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess Change in Parental Stress Level using the PSI-4 (Parent Stress Index-4)	Assess changes in parental stress level after treatments have been completed using the PSI-4 scale.	3 months

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Aviril Sepulveda, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Tracheal Diseases
• Other Study ID Numbers: APP-16-01573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes