Motor Learning in Dysphagia Rehabilitation

NCT02576470 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2019-10-04

No results posted yet for this study

Summary

The overall goal is to exploit motor learning principles and adjuvant techniques in a novel way to enhance dysphagia rehabilitation. The proposed study will investigate the effects of three forms of biofeedback on training and determine whether adjuvant therapeutic techniques such as non-invasive neural stimulation and reward augment training outcomes has an effect of dysphagia rehabilitation. Outcomes from this research study may change the paradigm for treating swallowing and other internal functions such as speech and voice disorders.

Conditions

Interventions

BEHAVIORAL

Biofeedback

Motor learning is improvement in movement overtime, followed by retaining what was learned. To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback. Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention. Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers. Biofeedback training will occur 3 times.

DEVICE

Transcranial Direct Current Stimulation

Weak direct currents can be applied non-invasively, transcranially and painlessly. Such application leads to transient changes in corticomotor excitability that are fully reversible. There are no known risks of tDCS of the brain, other than mild local discomfort at the electrode sites.The tDCS sessions will be separated by at least 24hrs, the electrode pads will not be used more than 4 times and they will be clean with a sterile saline solution.

BEHAVIORAL

Financial Reward

Motor learning training can be enhanced by adjuvant techniques such as non-invasive neural stimulation and explicit reward. Both influence the primary motor cortex (M1), a key neural substrate of motor skill learning. Non-invasive neural stimulation reduces dysphagia after stroke as measured with subjective swallowing severity scales, however it is unknown whether it could also enhance swallowing maneuver training. Explicit reward (i.e. financial) incentivizes successful gains during motor training. Explicit reward has never been investigated in swallowing rehabilitation. However, it has been shown that increasing stress and financial penalty can reduce swallowing frequency in healthy adults.

BEHAVIORAL

targeted dysphagia training maneuver

training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology

RADIATION

Videofluoroscopy (VF) and Barium

The videofluoroscopy (VF) and barium will be used to record swallowing in all participant groups. This will capture full resolution VF images of all subjects in real time in the lateral view. From the digital recording, image sequencing will be exported to an image processing computer system and archived. The image intensifier will be focused on the lips, posterior pharyngeal wall, hard palate, and just below the upper esophageal sphincter (UES), providing a full view of the oral cavity and neck. A simultaneously recorded time-code will facilitate frame-by-frame data analysis. VF is the only option for visualizing swallowing kinematics during the pharyngeal swallow.

DEVICE

Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation (TMS) will be used to provide a single-pulse to the brain.

DEVICE

Submental Electromyography

Submental Electromyography (sEMG) is used to train participants swallowing maneuvers.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • American Heart Association

    collaborator OTHER
  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH
  • University of Florida

    lead OTHER

Principal Investigators

  • Inaessa A Humbert, Ph.D. · University of Florida

  • Susan Nittrouer, Ph.D. · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2019-09-19
Completion
2019-09-19

Countries

  • United States

Study Locations

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Entities

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 NCT02576470 on ClinicalTrials.gov