New wearable tech aims to ease swallowing troubles for stroke and Parkinson's patients
NCT ID NCT06638944
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 5 times
Summary
This study tests a wearable sensor that tracks neck muscle activity during swallowing exercises, providing real-time feedback to patients. Researchers want to see if adding this device to standard therapy improves swallowing more than therapy alone. The study includes 120 adults aged 50-90 who have had a stroke or have Parkinson's disease and trouble swallowing. Participants will do a 12-week swallowing program either in the clinic or at home via telehealth.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 Exclusion Criteria: * 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 with the skin * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Purdue University
RECRUITINGWest Lafayette, Indiana, 47907, United States
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University of Illinois Urbana-Champaign
RECRUITINGChampaign, Illinois, 61820, United States
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