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Motor Learning in Dysphagia Rehabilitation

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University of Florida

Status

Terminated

Conditions

Dysphagia
Stroke
Swallowing Disorders
Deglutition Disorders

Treatments

Behavioral: Financial Reward
Device: Transcranial Direct Current Stimulation
Behavioral: Biofeedback
Behavioral: targeted dysphagia training maneuver
Radiation: Videofluoroscopy (VF) and Barium
Device: Transcranial Magnetic Stimulation
Device: Submental Electromyography

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02576470
IRB201500742-N
1R01DC014285-01A1 (U.S. NIH Grant/Contract)
14BGIA20380348 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

The overall goal is to exploit motor learning principles in a novel way to enhance dysphagia rehabilitation in patients with dysphagia due to stroke. Dysphagia is swallowing impairment that can lead to serious illness or death due to ingested material entering the trachea (aspiration). Specifically, this study will determine whether lasting behavioral modifications after swallowing training occur with motor learning principles versus standard care. Motor learning principles emphasize continual kinematic assessment through biofeedback during training. However, continual kinematic assessment is rare in standard dysphagia care because swallowing kinematics require instrumentation such as videofluoroscopy (VF) to be seen. Since VF involves radiation exposure and higher costs, submental electromyography (sEMG) is widely used as biofeedback, although it does not image swallowing kinematics or confirm that a therapeutic movement is being trained. This research study will compare three forms of biofeedback on training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology. VF biofeedback training will provide kinematic information about targeted dysphagia training performance, incorporating motor learning principles. sEMG biofeedback training will provide non-kinematic information about targeted dysphagia training performance and, thus, does not incorporate motor learning principles. A mixed biofeedback training, which involves VF biofeedback early on to establish the target kinematics of the targeted dysphagia training maneuver, then reinforces what was learned with sEMG. Mixed biofeedback training is being examined because it is more clinically feasible than VF biofeedback training, while still incorporating motor learning principles during part of the targeted dysphagia training.

The investigators hypothesize that VF training will reduce swallowing impairment more than mixed training, but mixed training will reduce swallowing impairment more than sEMG training. Additionally, this study will investigate whether adjuvant techniques known to augment motor training (non-invasive neural stimulation and explicit reward tested independently), will augment outcomes of each of the proposed training's. This innovative experimental design is significant because it investigates motor learning principles within an ideal training (VF biofeedback) as well as within a clinically feasible option (mixed biofeedback) to differentiate them from standard dysphagia training (sEMG), which has reported little to no improvements after intense motor training.

Enrollment

74 patients

Sex

All

Ages

21 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • swallowing problem

Exclusion criteria

  • pregnant
  • allergy to barium
  • moderate to severe dementia
  • serious respiratory illness

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

74 participants in 12 patient groups

Videofluoroscopy (VF) and Barium
Experimental group
Description:
This group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium to provide biofeedback for targeted dysphagia swallowing maneuver.
Treatment:
Radiation: Videofluoroscopy (VF) and Barium
Behavioral: Biofeedback
Behavioral: targeted dysphagia training maneuver
Surface Electromyography (sEMG)
Active Comparator group
Description:
This group will receive the following types of procedures during visits. sEMG images will be used to provide biofeedback for the targeted dysphagia swallowing maneuver.
Treatment:
Device: Submental Electromyography
Behavioral: Biofeedback
Behavioral: targeted dysphagia training maneuver
Mixed VF and sEMG
Active Comparator group
Description:
This 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.
Treatment:
Device: Submental Electromyography
Radiation: Videofluoroscopy (VF) and Barium
Behavioral: Biofeedback
Behavioral: targeted dysphagia training maneuver
VF with anodal tDCS
Experimental group
Description:
This 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.
Treatment:
Device: Transcranial Magnetic Stimulation
Radiation: Videofluoroscopy (VF) and Barium
Behavioral: Biofeedback
Device: Transcranial Direct Current Stimulation
Behavioral: targeted dysphagia training maneuver
sEMG with anodal tDCS
Experimental group
Description:
This 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.
Treatment:
Device: Submental Electromyography
Device: Transcranial Magnetic Stimulation
Behavioral: Biofeedback
Device: Transcranial Direct Current Stimulation
Behavioral: targeted dysphagia training maneuver
Mixed VF, sEMG with anodal tDCS
Experimental group
Description:
This 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.
Treatment:
Device: Submental Electromyography
Device: Transcranial Magnetic Stimulation
Radiation: Videofluoroscopy (VF) and Barium
Behavioral: Biofeedback
Device: Transcranial Direct Current Stimulation
Behavioral: targeted dysphagia training maneuver
VF with sham tDCS
Sham Comparator group
Description:
This 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.
Treatment:
Device: Transcranial Magnetic Stimulation
Radiation: Videofluoroscopy (VF) and Barium
Behavioral: Biofeedback
Device: Transcranial Direct Current Stimulation
Behavioral: targeted dysphagia training maneuver
sEMG with sham tDCS
Sham Comparator group
Description:
This 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.
Treatment:
Device: Submental Electromyography
Device: Transcranial Magnetic Stimulation
Behavioral: Biofeedback
Device: Transcranial Direct Current Stimulation
Behavioral: targeted dysphagia training maneuver
Mixed VF, sEMG with sham tDCS
Sham Comparator group
Description:
This 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.
Treatment:
Device: Submental Electromyography
Device: Transcranial Magnetic Stimulation
Radiation: Videofluoroscopy (VF) and Barium
Behavioral: Biofeedback
Device: Transcranial Direct Current Stimulation
Behavioral: targeted dysphagia training maneuver
VF with reward
Experimental group
Description:
This group will receive the following the procedure outlined below for biofeedback. The biofeedback is based on the videofluoroscopy (VF) and Barium with financial reward.
Treatment:
Radiation: Videofluoroscopy (VF) and Barium
Behavioral: Biofeedback
Behavioral: Financial Reward
Behavioral: targeted dysphagia training maneuver
sEMG with financial reward
Experimental group
Description:
This 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.
Treatment:
Device: Submental Electromyography
Behavioral: Biofeedback
Behavioral: Financial Reward
Behavioral: targeted dysphagia training maneuver
Mixed VF, sEMG with financial reward
Experimental group
Description:
This 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.
Treatment:
Device: Submental Electromyography
Radiation: Videofluoroscopy (VF) and Barium
Behavioral: Biofeedback
Behavioral: Financial Reward
Behavioral: targeted dysphagia training maneuver

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Data sourced from clinicaltrials.gov

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