Wearable Biofeedback for Swallowing Disorders

Overseen By Shelley Reichelt, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Purdue University

Disqualifiers: Recent pneumonia, Head/neck surgery, Others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment sEMG-biofeedback for swallowing disorders?

Research shows that using surface electromyography biofeedback (sEMG-BF) can help improve swallowing difficulties, especially in patients who have had a stroke. Studies have found that this treatment can be effective when combined with other therapies, like game training, to enhance swallowing skills. ^{1 2 3 4 5}

Is the wearable biofeedback device for swallowing disorders safe for humans?

The new wearable sEMG patch for monitoring swallowing is safe, with fewer mild adverse effects compared to conventional electrodes, and participants reported higher satisfaction with it. ^{2 6 7 8 9}

How does the wearable biofeedback treatment for swallowing disorders differ from other treatments?

The wearable biofeedback treatment for swallowing disorders is unique because it uses a wireless, skin-mounted sensor to continuously monitor swallowing and respiratory activities in real-time, providing feedback through a user-friendly interface. Unlike traditional treatments that require bulky, expensive equipment in clinical settings, this portable device allows for remote monitoring and telehealth applications, making it more accessible and convenient for patients. ^{2 4 6 10 11}

Research Team

Georgia Malandraki, PhD

Principal Investigator

Purdue University

Eligibility Criteria

This trial is for individuals with swallowing difficulties after a stroke or those diagnosed with Parkinson's Disease. Participants will undergo a 12-week swallow therapy protocol and must be able to attend three in-person evaluations. They should also commit to exercising at home and maintaining an exercise diary.

Inclusion Criteria

Score in the normal/mild range on the Montreal Cognitive Assessment (MoCA) determined during an in-house screening

I am between 50 and 90 years old.

I was diagnosed with a stroke or Parkinson's disease (stages II-IV) over 3 months ago.

Exclusion Criteria

Known allergies relating to the Ten20® Conductive Paste or sensor materials (gold/acrylic) used in the study

Inability to perform prescribed exercises accurately after a maximum of 12 practice trials as evaluated by the certified and trained SLP during the intervention VFSS assessment

I have had pneumonia in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a 12-week swallow treatment protocol using the i-Phagia system, either in-person or via telehealth, with weekly treatment sessions and home exercises.

12 weeks

12 treatment visits (in-person or virtual), 3 in-person evaluations

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluations at 1 week and 12 weeks post-treatment.

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• sEMG-biofeedback

Trial Overview The study tests if using wearable biofeedback technology (i-Phagia) alongside standard swallow therapy improves swallowing function better than standard treatment alone, both in-person and via telehealth. It also examines which patient factors affect the success of the treatment.

Participant Groups

Group I: Standard-of-Care (SOC) Swallow Treatment Experimental Treatment 1 Intervention

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.

Group II: IN-person i-Phagia Experimental Treatment 1 Intervention

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.

Group III: Remote i-Phagia Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials

239

Recruited

72,200+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effects of electromyographic biofeedback as an adjunctive therapy in the treatment of swallowing disorders: a systematic review of the literature. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Soft skin-interfaced mechano-acoustic sensors for real-time monitoring and patient feedback on respiratory and swallowing biomechanics. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of game training combined with surface electromyography biofeedback on post-stroke dysphagia. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Advanced Machine Learning Tools to Monitor Biomarkers of Dysphagia: A Wearable Sensor Proof-of-Concept Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Randomized controlled feasibility trial of swallow strength and skill training with surface electromyographic biofeedback in acute stroke patients with dysphagia. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Validation of a Novel Wearable Electromyography Patch for Monitoring Submental Muscle Activity During Swallowing: A Randomized Crossover Trial. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

Masseter and digastric muscle activity evaluation using a novel electromyogram that utilizes elastic sheet electrodes. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Identification of swallowing events from sEMG Signals Obtained from Healthy Adults. [2019]

9. China pubmed.ncbi.nlm.nih.gov

[Surface electromyographic study on swallowing in normal adults]. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Fabrication of Skin-Mountable Flexible Sensor Patch for Monitoring of Swallowing Function. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Measuring frequency of spontaneous swallowing. [2019]