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New treatment option for Dysphagia
Official title Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
ClinicalTrials.gov ID: NCT06638944
What this study is testing
- What it's testing
- Dysphagia, or difficulty swallowing, is a common symptom of many neurological diseases but its treatment is not well established or easily accessible. To start addressing this gap, the researchers developed and validated a cost-effective wearable surface electromyography (sEMG) biofeedback sensor technology (i-Phagia), optimized to record muscle activity from the head/neck and provide biofeedback to patients and adherence data to clinicians during swallow therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 90
You may be able to join if
- 50-90 years old
- a confirmed (by a neurologist/physician) diagnosis of stroke at least 3 months post event, or of PD (Hoehn and Yahr Stages II-IV)
- score in the normal/mild range on the Montreal Cognitive Assessment (MoCA), determined during an in-house screening
- confirmed oropharyngeal dysphagia, as evaluated during the intervention eligibility assessment by a certified and trained Speech Language Pathologist...
- accuracy of exercise performance; as evaluated during the intervention eligibility assessment by a certified and trained SLP
You likely can't join if
- known allergy to barium or known/suspected perforation or obstruction of the gastrointestinal (GI) tract
- recent history of pneumonia (past 6 months)
- head and neck surgery, radiation or trauma
- a score in the moderate-severe range on MoCA (screened during in-house screening)
- other neurological/neuromuscular disorders (e.g., multiple sclerosis, brain tumor, myositis, etc)
- difficulty complying due to neuropsychological dysfunction determined during the in-house screening
See the full eligibility criteria
- 50-90 years old
- a confirmed (by a neurologist/physician) diagnosis of stroke at least 3 months post event, or of PD (Hoehn and Yahr Stages II-IV)
- score in the normal/mild range on the Montreal Cognitive Assessment (MoCA), determined during an in-house screening
- confirmed oropharyngeal dysphagia, as evaluated during the intervention eligibility assessment by a certified and trained Speech Language Pathologist (SLP)
- accuracy of exercise performance; as evaluated during the intervention eligibility assessment by a certified and trained SLP
- independent (or with caregiver support) use of i-Phagia system post pre-intervention training session; as evaluated during the intervention eligibility assessment by a certified and trained SLP
- known allergy to barium or known/suspected perforation or obstruction of the gastrointestinal (GI) tract
- recent history of pneumonia (past 6 months)
- head and neck surgery, radiation or trauma
- a score in the moderate-severe range on MoCA (screened during in-house screening)
- other neurological/neuromuscular disorders (e.g., multiple sclerosis, brain tumor, myositis, etc)
- difficulty complying due to neuropsychological dysfunction determined during the in-house screening
- currently enrolled in swallow or speech therapy
- facial hair in the submental (under the chin) area and refusing to shave.
- known allergies relating to the Ten20® Conductive Paste (this is the conductive paste used to help with sensors signal and adherence to the skin) and/or any of the sensor materials (gold/acrylic) that come into contact...
- no oropharyngeal dysphagia; as evaluated during the intervention eligibility assessment by the certified and trained SLP
- inability to perform the prescribed exercises accurately after a maximum of 12 practice trials; as evaluated during the intervention eligibility VFSS assessment by the certified and trained SLP
- inability to use the system accurately post training (for i-Phagia groups); as evaluated during the intervention eligibility assessment by the certified and trained SLP
- inability to safely swallow (without aspiration) at least one consistency; as evaluated during the intervention eligibility assessment by the certified and trained SLP
The study team makes the final eligibility decision.
Where it's taking place
- Champaign, Illinois, United States
- West Lafayette, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Champaign, Illinois, United States; West Lafayette, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.