Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease

Purdue University

Status and phase: Enrolling; Phase 2

Conditions: Dysphagia; Stroke; Parkinson Disease

Treatments: Behavioral: In-person sEMG-biofeedback; Behavioral: Remote sEMG-biofeedback; Behavioral: Standard-of-care treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06638944

1R01AG086371-01 (U.S. NIH Grant/Contract)

IRB-2024-2

Details and patient eligibility

About

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. This system has been developed with commercially available and widely used materials and the Purdue University IRB has determined that the device is non-significant risk device.

The goal of this clinical trial is to learn if this biofeedback (using this new technology/i-Phagia) when used as an adjunct to a standard swallow therapy protocol works to improve swallowing function in patients post chronic stroke or diagnosed with Parkinson's disease. It will also help the investigators learn whether this therapy protocol is equally effective when provided in-person versus via telehealth. Finally, it will determine which patient factors may influence how well the treatment works.

The main questions it aims to answer are:

• Does biofeedback (using this new technology/i-Phagia) when used as an adjunct to a standard swallow therapy protocol works better than a standard of care treatment to improve swallowing function in patients post chronic stroke or diagnosed with Parkinson's disease?
• Is completing the swallow therapy protocol at home (via telehealth) as effective as completing it in-person (in the clinic)?
• What factors related to the patients (e.g., age, diagnosis, etc.) may influence how well the treatment works?

Participants will:

• Complete a 12-week swallow treatment protocol (12 treatment visits) either in-person or at home (via telehealth)
• Complete 3 in-person evaluations (pre-treatment; post-treatment; and at a 12-week post treatment follow-up time point)
• Exercise at home several days per week and keep a diary/log of their home exercise

The hypothesis is that upon study completion, the efficacy of sEMG biofeedback-facilitated swallow therapy for both in-person and telehealth service delivery in two neurogenic dysphagia populations will have been established, and variables determining response to treatment will begin to be identified.

Enrollment: 120 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

IN-person i-Phagia

Experimental group

Description:

The treatment group assigned to the IN-PERSON i-Phagia service delivery will use the system to complete a standardized swallowing rehabilitation protocol for 12 weeks with weekly (once per week) treatment sessions in the clinic and 3 days of home practice per week.

Treatment:

Behavioral: In-person sEMG-biofeedback

Remote i-Phagia

Active Comparator group

Description:

The treatment group assigned to the REMOTE i-Phagia service delivery will use the i-Phagia system to complete a standardized swallowing rehabilitation protocol for 12 weeks with weekly (once per week) treatment sessions completed remotely (via telehealth) and 3 days of home practice per week.

Treatment:

Behavioral: Remote sEMG-biofeedback

Standard-of-Care (SOC) Swallow Treatment

Other group

Description:

The treatment group assigned to the SOC service delivery will complete the same standardized swallowing rehabilitation protocol and in the same frequency as the i-Phagia groups but without the device. That is, they will complete the protocol for 12 weeks with weekly (once per week) treatment sessions completed in-person and 3 days of home practice per week.

Treatment:

Behavioral: Standard-of-care treatment