Active NMES + Swallowing Exercise for Swallowing Difficulty

N/A

Waitlist Available

Led By Susan Langmore, PhD,SLP,BRS

Research Sponsored by Boston Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after treatment

Summary

The purpose of the investigation is to learn whether intense swallowing exercise or intense swallowing exercise coupled with electrical stimulation (E-Stim) helps patients who had head/neck cancer and currently have dysphagia swallow better.

Eligible Conditions

Swallowing Difficulty

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Penetration-Aspiration Scale (PAS) Score

Secondary study objectives

Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active NMES + Swallowing ExerciseActive Control1 Intervention

Active Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) therapy will be paired concomitantly with repeated effortful sallowing exercises, for 60 swallows, 2 times per day, 6 days per week, for 12 weeks.

Group II: Sham NMES + Swallowing ExercisePlacebo Group1 Intervention

Sham (inactive) Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) therapy will be paired concomitantly with repeated effortful sallowing exercises, for 60 swallows, 2 times per day, 6 days per week, for 12 weeks.

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