i-BiSSkApp for Swallowing Rehabilitation in Parkinson's Disease

NCT05837520 | Unknown Phase 1 FDA Device

• 1 other identifier: STUDY005198
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Aspiration pneumonia due to dysphagia is a leading cause of death in Parkinson's disease (PD). Dysphagia intervention in the United States involves evaluation at onset of dysphagia symptoms followed by short-term therapy. Traditional therapy relies on verbal instruction and low-tech at-home exercise regimens without visual biofeedback; lacking a monitoring of accuracy or strength of exercise. Available biofeedback is office-based, bulky and expensive, thus, not readily used. The Biofeedback in Strength and Skill Training (BiSSKit) is a well-researched office based biofeedback system that has recently been converted into an affordable and accessible home-based application. This study aims to investigate the impact of swallowing therapy using the BiSSKit app on airway protective outcomes in patients with PD. Thirty participants with PD and dysphagia will be recruited for this study. Participants will undergo a baseline-modified barium swallowing (MBS) evaluation followed by 12 weekly sessions of swallowing therapy. Participants will be randomized to two swallowing therapy groups (1) traditional (2) BiSSKit app. Participants will undergo MBS following therapy completion. Outcome measures include swallowing safety, pharyngeal kinematics, and swallowing-related quality of life. We hypothesize that use of the BiSSKit will result in improved swallowing function compared to the traditional swallowing therapy group.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

• Penetration Aspiration Scale Score (PAS)

  8 point ordinal scale to assess swallowing safety.

  Baseline

• Penetration Aspiration Scale Score (PAS)

  8 point ordinal scale to assess swallowing safety.

  Post-12 weeks of intervention

• Total Pharyngeal Residue

  This is the amount of residue within the valleculae and piriform sinuses after the completion of a swallow.

  Baseline

• Total Pharyngeal Residue

  This is the amount of residue within the valleculae and piriform sinuses after the completion of a swallow.

  Post-12 weeks of intervention

Secondary Outcomes (2)

• Eating Assessment Tool-10 (EAT-10)

  Baseline

• Eating Assessment Tool-10 (EAT-10)

  Post-12 weeks of intervention

Study Arms (2)

i-BiSSkApp Group

EXPERIMENTAL

This group will complete daily swallowing behavioral exercises with simultaneous at-home sEMG biofeedback using a tablet application. Participants will participate in weekly clinic visits and at-home therapy for 12 weeks.

Device: i-BiSSkApp (tablet application) with swallowing therapy

Traditional Treatment

ACTIVE COMPARATOR

This group will receive traditional swallowing therapy once a week for 12 weeks using standard therapy practices. They will also complete at-home daily practice of these exercises.

Behavioral: Traditional behavioral swallowing therapy

Interventions

i-BiSSkApp (tablet application) with swallowing therapy DEVICE

The device, "International Biofeedback Strength and Skill App (i-BiSSkApp)" is an at-home swallowing biofeedback tool (hardware and software) to target rehabilitation of both skill and strength of swallowing function. The program utilizes submental surface electromyography coupled with a user-friendly interface to display visual feedback of swallowing strength and timing.

i-BiSSkApp Group

Traditional behavioral swallowing therapy BEHAVIORAL

Participants will receive standard behavioral swallowing exercises based on the results of a swallowing evaluation. Participants will complete daily at-home exercises with written and verbal instructions and return weekly to clinic for 12 weeks of therapy.

Traditional Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PD by a fellowship trained movement disorders neurologist
• Able to provide informed consent.
• Older than 18 years of age.
• Evidence of oropharyngeal swallowing deficits as determined during a standard of care MBSS.

You may not qualify if:

• Show evidence of cognitive impairment prohibiting completion of self-informed consent.
• Have a history of stroke or other traumatic brain injury.
• Have a history of previous dysphagia treatment.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Univerity of South Florida

Tampa, Florida, 33612, United States

Location

Related Publications (9)

• Tabor-Gray LC, Gallestagui A, Vasilopoulos T, Plowman EK. Characteristics of impaired voluntary cough function in individuals with amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Feb;20(1-2):37-42. doi: 10.1080/21678421.2018.1510011. Epub 2019 Jan 17.

  PMID: 30652513 BACKGROUND

• Ebihara S, Saito H, Kanda A, Nakajoh M, Takahashi H, Arai H, Sasaki H. Impaired efficacy of cough in patients with Parkinson disease. Chest. 2003 Sep;124(3):1009-15. doi: 10.1378/chest.124.3.1009.

  PMID: 12970031 BACKGROUND

• Smith Hammond CA, Goldstein LB, Zajac DJ, Gray L, Davenport PW, Bolser DC. Assessment of aspiration risk in stroke patients with quantification of voluntary cough. Neurology. 2001 Feb 27;56(4):502-6. doi: 10.1212/wnl.56.4.502.

  PMID: 11222795 BACKGROUND

• Fall PA, Saleh A, Fredrickson M, Olsson JE, Granerus AK. Survival time, mortality, and cause of death in elderly patients with Parkinson's disease: a 9-year follow-up. Mov Disord. 2003 Nov;18(11):1312-6. doi: 10.1002/mds.10537.

  PMID: 14639673 BACKGROUND

• Troche MS, Rosenbek JC, Okun MS, Sapienza CM. Detraining outcomes with expiratory muscle strength training in Parkinson disease. J Rehabil Res Dev. 2014;51(2):305-10. doi: 10.1682/JRRD.2013.05.0101.

  PMID: 24933728 BACKGROUND

• Crary MA, Carnaby GD, LaGorio LA, Carvajal PJ. Functional and physiological outcomes from an exercise-based dysphagia therapy: a pilot investigation of the McNeill Dysphagia Therapy Program. Arch Phys Med Rehabil. 2012 Jul;93(7):1173-8. doi: 10.1016/j.apmr.2011.11.008. Epub 2012 Feb 25.

  PMID: 22365489 BACKGROUND

• Crary MA, Carnaby Mann GD, Groher ME, Helseth E. Functional benefits of dysphagia therapy using adjunctive sEMG biofeedback. Dysphagia. 2004 Summer;19(3):160-4. doi: 10.1007/s00455-004-0003-8.

  PMID: 15383945 BACKGROUND

• Athukorala RP, Jones RD, Sella O, Huckabee ML. Skill training for swallowing rehabilitation in patients with Parkinson's disease. Arch Phys Med Rehabil. 2014 Jul;95(7):1374-82. doi: 10.1016/j.apmr.2014.03.001. Epub 2014 May 9.

  PMID: 24816250 BACKGROUND

• Jenks J, Pitts LL. Effects of an Intensive Exercise-Based Swallowing Program for Persons With Parkinson's Disease and Complex Medical History: A Single-Case Experiment. Am J Speech Lang Pathol. 2019 Aug 9;28(3):1268-1274. doi: 10.1044/2019_AJSLP-18-0168. Epub 2019 Jul 23.

  PMID: 31335179 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Stephanie Watts, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie A Watts, PhD

CONTACT

813-821-8012; srandall1@usf.edu

Alex Brandimore, PhD

CONTACT

813-974-9844; abrandimore@usf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 1, 2023
• Study Start: June 15, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)