DysphagiaNCT02576470
Motor Learning in Dysphagia Rehabilitation
A study testing Biofeedback, Transcranial Direct Current Stimulation and Financial Reward in people with Dysphagia and Swallowing Disorders, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Swallowing Disorders, Deglutition Disorders
- What is being tested?
- Biofeedback, Transcranial Direct Current Stimulation and Financial Reward
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 19 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- swallowing problem
Who cannot join
- pregnant
- allergy to barium
- moderate to severe dementia
- serious respiratory illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Dental Tower Room 130 (DG130)
Gainesville, Florida, 32610
About this study
Official title: Applying Motor Learning Principles to Dysphagia Rehabilitation R01DC014285
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.
Read the detailed 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.
- Conditions
- Dysphagia, Swallowing Disorders, Deglutition Disorders, Stroke
- Being tested
- Biofeedback, Transcranial Direct Current Stimulation, Financial Reward, targeted dysphagia training maneuver, Videofluoroscopy (VF) and Barium
- Keywords
- swallowing, stroke, dysphagia, deglutition
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackBehavioural
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.
Transcranial Direct Current StimulationDevice
Also called tDCS
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.
Financial RewardBehavioural
Also called Explicit 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.
targeted dysphagia training maneuverBehavioural
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
Videofluoroscopy (VF) and BariumRadiation
Also called VF
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 StimulationDevice
Also called TMS
Transcranial Magnetic Stimulation (TMS) will be used to provide a single-pulse to the brain.
Submental ElectromyographyDevice
Also called sEMG
Submental Electromyography (sEMG) is used to train participants swallowing maneuvers.
| Study group | Role | What they receive |
|---|---|---|
| Videofluoroscopy (VF) and Barium | Experimental | This group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium to provide biofeedback for targeted dysphagia swallowing maneuver. Receives: Behavioral: Biofeedback; Behavioral: targeted dysphagia training maneuver; Radiation: Videofluoroscopy (VF) and Barium |
| Surface Electromyography (sEMG) | Active comparator | 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. Receives: Behavioral: Biofeedback; Behavioral: targeted dysphagia training maneuver; Device: Submental Electromyography |
| Mixed VF and sEMG | Active comparator | 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. Receives: Behavioral: Biofeedback; Behavioral: targeted dysphagia training maneuver; Radiation: Videofluoroscopy (VF) and Barium; Device: Submental Electromyography |
| VF with anodal tDCS | Experimental | 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. Receives: Behavioral: Biofeedback; Device: Transcranial Direct Current Stimulation; Behavioral: targeted dysphagia training maneuver; Radiation: Videofluoroscopy (VF) and Barium; Device: Transcranial Magnetic Stimulation |
| sEMG with anodal tDCS | Experimental | 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. Receives: Behavioral: Biofeedback; Device: Transcranial Direct Current Stimulation; Behavioral: targeted dysphagia training maneuver; Device: Transcranial Magnetic Stimulation; Device: Submental Electromyography |
| Mixed VF, sEMG with anodal tDCS | Experimental | 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. Receives: Behavioral: Biofeedback; Device: Transcranial Direct Current Stimulation; Behavioral: targeted dysphagia training maneuver; Radiation: Videofluoroscopy (VF) and Barium; Device: Transcranial Magnetic Stimulation; Device: Submental Electromyography |
| VF with sham tDCS | Sham comparator | 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. Receives: Behavioral: Biofeedback; Device: Transcranial Direct Current Stimulation; Behavioral: targeted dysphagia training maneuver; Radiation: Videofluoroscopy (VF) and Barium; Device: Transcranial Magnetic Stimulation |
| sEMG with sham tDCS | Sham comparator | 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. Receives: Behavioral: Biofeedback; Device: Transcranial Direct Current Stimulation; Behavioral: targeted dysphagia training maneuver; Device: Transcranial Magnetic Stimulation; Device: Submental Electromyography |
| Mixed VF, sEMG with sham tDCS | Sham comparator | 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. Receives: Behavioral: Biofeedback; Device: Transcranial Direct Current Stimulation; Behavioral: targeted dysphagia training maneuver; Radiation: Videofluoroscopy (VF) and Barium; Device: Transcranial Magnetic Stimulation; Device: Submental Electromyography |
| VF with reward | Experimental | 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. Receives: Behavioral: Biofeedback; Behavioral: Financial Reward; Behavioral: targeted dysphagia training maneuver; Radiation: Videofluoroscopy (VF) and Barium |
| sEMG with financial reward | Experimental | 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. Receives: Behavioral: Biofeedback; Behavioral: Financial Reward; Behavioral: targeted dysphagia training maneuver; Device: Submental Electromyography |
| Mixed VF, sEMG with financial reward | Experimental | 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. Receives: Behavioral: Biofeedback; Behavioral: Financial Reward; Behavioral: targeted dysphagia training maneuver; Radiation: Videofluoroscopy (VF) and Barium; Device: Submental Electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Bolus targeted dysphagia training maneuvers will be trained to determine whether skills learned during saliva targeted dysphagia maneuver training transfer to the bolus targeted dysphagia maneuver context. The bolus targeted dysphagia maneuver will be analyzed with a linear mixed-effects model to estimate the effect of training group.
Measured: 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.
Kinematic measures will include LVC duration, LVC response time (LVCrt), and sequence of bolus flow and LVC events. LVC is defined as the first frame when the inverted epiglottis has approximated the arytenoids, resulting in no airspace within the hyo-laryngeal structures on a lateral view, until the first frame when airspace returns and the structures begin to separate. Kinematic measure will be analyzed with a linear mixed-effects model to estimate the effect of training group.
Measured: Changes from 24 hours, 1 week, and 1 month
Training effect on financial reward analysis between 3 groups
The financial reward will be analyzed by using a power calculation and is based on preliminary data where financial reward increased training effect by 344%, yielding a power calculation of 8 participants for each of the 3 training groups (24 participants).
Measured: Changes from days 1, 2, and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startNov 2015
- Primary completion19 Sep 2019
- Study completion19 Sep 2019
Why it stopped: Expired with IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), American Heart Association, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Inaessa A Humbert, Ph.D., Principal investigator, University of FloridaSusan Nittrouer, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576470
- Sponsor's protocol ID
- IRB201500742-N
- Other IDs
- 14BGIA20380348, 1R01DC014285-01A1
- Status last verified
- Oct 2019
- First submitted
- 12 Oct 2015
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26426312Macrae 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.
PubMed 24528182Humbert 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.
PubMed 23192633
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Motor Learning Principles to Dysphagia Rehabilitation R01DC014285
- ClinicalTrials.gov ID
- NCT02576470
- Acronym / sponsor ID
- IRB201500742-N
- Conditions
- Dysphagia, Swallowing Disorders, Deglutition Disorders, Stroke
- Keywords
- swallowing, stroke, dysphagia, deglutition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Expired with IRB.
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), American Heart Association, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Nov 2015
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Videofluoroscopy (VF) and Barium | Experimental | Behavioral: Biofeedback, Behavioral: targeted dysphagia training maneuver, Radiation: Videofluoroscopy (VF) and BariumThis 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 comparator | Behavioral: Biofeedback, Behavioral: targeted dysphagia training maneuver, Device: Submental ElectromyographyThis 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 comparator | Behavioral: Biofeedback, Behavioral: targeted dysphagia training maneuver, Radiation: Videofluoroscopy (VF) and Barium, Device: Submental ElectromyographyThis 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 | Experimental | Behavioral: Biofeedback, Device: Transcranial Direct Current Stimulation, Behavioral: targeted dysphagia training maneuver, Radiation: Videofluoroscopy (VF) and Barium, Device: Transcranial Magnetic StimulationThis 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 | Experimental | Behavioral: Biofeedback, Device: Transcranial Direct Current Stimulation, Behavioral: targeted dysphagia training maneuver, Device: Transcranial Magnetic Stimulation, Device: Submental ElectromyographyThis 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 | Experimental | Behavioral: Biofeedback, Device: Transcranial Direct Current Stimulation, Behavioral: targeted dysphagia training maneuver, Radiation: Videofluoroscopy (VF) and Barium, Device: Transcranial Magnetic Stimulation, Device: Submental ElectromyographyThis 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 comparator | Behavioral: Biofeedback, Device: Transcranial Direct Current Stimulation, Behavioral: targeted dysphagia training maneuver, Radiation: Videofluoroscopy (VF) and Barium, Device: Transcranial Magnetic StimulationThis 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 comparator | Behavioral: Biofeedback, Device: Transcranial Direct Current Stimulation, Behavioral: targeted dysphagia training maneuver, Device: Transcranial Magnetic Stimulation, Device: Submental ElectromyographyThis 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 comparator | Behavioral: Biofeedback, Device: Transcranial Direct Current Stimulation, Behavioral: targeted dysphagia training maneuver, Radiation: Videofluoroscopy (VF) and Barium, Device: Transcranial Magnetic Stimulation, Device: Submental ElectromyographyThis 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 | Experimental | Behavioral: Biofeedback, Behavioral: Financial Reward, Behavioral: targeted dysphagia training maneuver, Radiation: Videofluoroscopy (VF) and BariumThis 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 | Experimental | Behavioral: Biofeedback, Behavioral: Financial Reward, Behavioral: targeted dysphagia training maneuver, Device: Submental ElectromyographyThis 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 | Experimental | Behavioral: Biofeedback, Behavioral: Financial Reward, Behavioral: targeted dysphagia training maneuver, Radiation: Videofluoroscopy (VF) and Barium, Device: Submental ElectromyographyThis 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- swallowing problem
Key exclusion criteria (4 listed)
- pregnant
- allergy to barium
- moderate to severe dementia
- serious respiratory illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiofeedbackMotor 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. | Behavioural | Mixed VF and sEMG, Mixed VF, sEMG with anodal tDCS, Mixed VF, sEMG with financial reward, Mixed VF, sEMG with sham tDCS, Surface Electromyography (sEMG), VF with anodal tDCS, VF with reward, VF with sham tDCS, Videofluoroscopy (VF) and Barium, sEMG with anodal tDCS, sEMG with financial reward, sEMG with sham tDCS |
| Transcranial Direct Current StimulationAlso: tDCSWeak 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. | Device | Mixed VF, sEMG with anodal tDCS, Mixed VF, sEMG with sham tDCS, VF with anodal tDCS, VF with sham tDCS, sEMG with anodal tDCS, sEMG with sham tDCS |
| Financial RewardAlso: Explicit RewardMotor 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. | Behavioural | Mixed VF, sEMG with financial reward, VF with reward, sEMG with financial reward |
| targeted dysphagia training maneuvertraining swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology | Behavioural | Mixed VF and sEMG, Mixed VF, sEMG with anodal tDCS, Mixed VF, sEMG with financial reward, Mixed VF, sEMG with sham tDCS, Surface Electromyography (sEMG), VF with anodal tDCS, VF with reward, VF with sham tDCS, Videofluoroscopy (VF) and Barium, sEMG with anodal tDCS, sEMG with financial reward, sEMG with sham tDCS |
| Videofluoroscopy (VF) and BariumAlso: VFThe 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. | Radiation | Mixed VF and sEMG, Mixed VF, sEMG with anodal tDCS, Mixed VF, sEMG with financial reward, Mixed VF, sEMG with sham tDCS, VF with anodal tDCS, VF with reward, VF with sham tDCS, Videofluoroscopy (VF) and Barium |
| Transcranial Magnetic StimulationAlso: TMSTranscranial Magnetic Stimulation (TMS) will be used to provide a single-pulse to the brain. | Device | Mixed VF, sEMG with anodal tDCS, Mixed VF, sEMG with sham tDCS, VF with anodal tDCS, VF with sham tDCS, sEMG with anodal tDCS, sEMG with sham tDCS |
| Submental ElectromyographyAlso: sEMGSubmental Electromyography (sEMG) is used to train participants swallowing maneuvers. | Device | Mixed VF and sEMG, Mixed VF, sEMG with anodal tDCS, Mixed VF, sEMG with financial reward, Mixed VF, sEMG with sham tDCS, Surface Electromyography (sEMG), sEMG with anodal tDCS, sEMG with financial reward, sEMG with sham tDCS |
Primary outcome
8-Point Penetration-Aspiration scale (P-A scale) will be used to swallowing ability
Time frame: Changes from 24 hrs, 1 week, 1 month
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.
Targeted dysphagia training biofeedback using VF images will be used to determine the changes from 24 hours, 1 week, and 1 month
Time frame: 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.
Targeted dysphagia training biofeedback using sEMG measures will be used to determine the changes from 24 hours, 1 week and 1 month
Time frame: 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).
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
Time frame: Changes from 24 hours, 1 week, and 1 month
The mixed biofeedback training will be recorded with sEMG for comparison with VF data.
3 secondary outcomes
Training bolus targeted dysphagia maneuvers changes from 24 hours, 1 week, and 1 month
Time frame: 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.
Time frame: Changes from 24 hours, 1 week, and 1 month
Training effect on financial reward analysis between 3 groups
Time frame: Changes from days 1, 2, and 3
Results and safety
The study was stopped early (reason given: Expired with IRB.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Background: PubMed 26426312Azola 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.
- Background: PubMed 24528182Macrae 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.
- Background: PubMed 23192633Humbert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inaessa A Humbert, Ph.D. principal investigator
University of Florida
Susan Nittrouer, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback, Transcranial Direct Current Stimulation and Financial Reward in people with Dysphagia and Swallowing Disorders, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Expired with IRB.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
8-Point Penetration-Aspiration scale (P-A scale) will be used to swallowing ability (time frame: Changes from 24 hrs, 1 week, 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02576470, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.