Study Stopped
Expired with IRB.
Motor Learning in Dysphagia Rehabilitation
Applying Motor Learning Principles to Dysphagia Rehabilitation R01DC014285
3 other identifiers
interventional
74
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2019
CompletedOctober 4, 2019
October 1, 2019
3.9 years
October 12, 2015
October 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
8-Point Penetration-Aspiration scale (P-A scale) will be used to swallowing ability
The P-A scale is measured on a score of 1 - 8 with 1 being the best possible score - material does not enter the airway, to 8 being the worse score - material enters the airway, passes below the vocal folds, and no effort is made to eject.
Changes from 24 hrs, 1 week, 1 month
Targeted dysphagia training biofeedback using VF images will be used to determine the changes from 24 hours, 1 week, and 1 month
VF biofeedback training group will test an ideal treatment circumstance using motor learning principles, where kinematic biofeedback is provided throughout training.
Changes from 24 hours, 1 week, and 1 month
Targeted dysphagia training biofeedback using sEMG measures will be used to determine the changes from 24 hours, 1 week and 1 month
The sEMG biofeedback training will be acquired with surface electrodes placed on the face and/or neck using the Dual Bio Amp (ADInstruments).
Changes from 24 hours, 1 week, and 1 month
Targeted dysphagia training biofeedback using both VF and sEMG measures will be used to determine the changes from 24 hours, 1 week and 1 month
The mixed biofeedback training will be recorded with sEMG for comparison with VF data.
Changes from 24 hours, 1 week, and 1 month
Secondary Outcomes (3)
Training bolus targeted dysphagia maneuvers changes from 24 hours, 1 week, and 1 month
Changes from 24 hours, 1 week, and 1 month
Kinematic analysis will be performed on targeted dysphagia maneuver changes from 24 hours, 1 week, and 1 month.
Changes from 24 hours, 1 week, and 1 month
Training effect on financial reward analysis between 3 groups
Changes from days 1, 2, and 3
Study Arms (12)
Videofluoroscopy (VF) and Barium
EXPERIMENTALThis group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium to provide biofeedback for targeted dysphagia swallowing maneuver.
Surface Electromyography (sEMG)
ACTIVE COMPARATORThis group will receive the following types of procedures during visits. sEMG images will be used to provide biofeedback for the targeted dysphagia swallowing maneuver.
Mixed VF and sEMG
ACTIVE COMPARATORThis group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium, and EMG images will be used to provide biofeedback for the targeted dysphagia swallowing maneuver.
VF with anodal tDCS
EXPERIMENTALThis group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
sEMG with anodal tDCS
EXPERIMENTALThis group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images with anodal transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
Mixed VF, sEMG with anodal tDCS
EXPERIMENTALThis group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The anodal tDCS will be applied to the lesioned hemisphere during training.
VF with sham tDCS
SHAM COMPARATORThis group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium images without the transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
sEMG with sham tDCS
SHAM COMPARATORThis group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images without the transcranial direct current stimulation and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
Mixed VF, sEMG with sham tDCS
SHAM COMPARATORThis group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images without transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). The tDCS will be applied during training, however no stimulation will be received.
VF with reward
EXPERIMENTALThis group will receive the following the procedure outlined below for biofeedback. The biofeedback is based on the videofluoroscopy (VF) and Barium with financial reward.
sEMG with financial reward
EXPERIMENTALThis group will receive the following types of procedures for biofeedback. The biofeedback is based on submental electromyography (sEMG) images with financial reward. The financial reward will only be done for 3-days.
Mixed VF, sEMG with financial reward
EXPERIMENTALThis group will receive the following types of procedures for biofeedback. The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with financial reward. The financial reward will only be done for 3 days.
Interventions
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.
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.
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.
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
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.
Transcranial Magnetic Stimulation (TMS) will be used to provide a single-pulse to the brain.
Submental Electromyography (sEMG) is used to train participants swallowing maneuvers.
Eligibility Criteria
You may qualify if:
- swallowing problem
You may not qualify if:
- pregnant
- allergy to barium
- moderate to severe dementia
- serious respiratory illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- National Institutes of Health (NIH)collaborator
- American Heart Associationcollaborator
- National Institute on Deafness and Other Communication Disorders (NIDCD)collaborator
Study Sites (1)
University of Florida Dental Tower Room 130 (DG130)
Gainesville, Florida, 32610, United States
Related Publications (3)
Azola AM, Greene LR, Taylor-Kamara I, Macrae P, Anderson C, Humbert IA. The Relationship Between Submental Surface Electromyography and Hyo-Laryngeal Kinematic Measures of Mendelsohn Maneuver Duration. J Speech Lang Hear Res. 2015 Dec;58(6):1627-36. doi: 10.1044/2015_JSLHR-S-14-0203.
PMID: 26426312BACKGROUNDMacrae P, Anderson C, Taylor-Kamara I, Humbert I. The effects of feedback on volitional manipulation of airway protection during swallowing. J Mot Behav. 2014;46(2):133-9. doi: 10.1080/00222895.2013.878303. Epub 2014 Feb 14.
PMID: 24528182BACKGROUNDHumbert IA, German RZ. New directions for understanding neural control in swallowing: the potential and promise of motor learning. Dysphagia. 2013 Mar;28(1):1-10. doi: 10.1007/s00455-012-9432-y. Epub 2012 Nov 30.
PMID: 23192633BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inaessa A Humbert, Ph.D.
University of Florida
- PRINCIPAL INVESTIGATOR
Susan Nittrouer, Ph.D.
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2015
First Posted
October 15, 2015
Study Start
November 1, 2015
Primary Completion
September 19, 2019
Study Completion
September 19, 2019
Last Updated
October 4, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share