Dental Appliance for Parkinson's Disease

NCT04082663 | Completed Results FDA Device

• 1 other identifier: 201904098
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are evaluating the immediate effect of a dental mouthpiece on gait and balance among people with Parkinson disease as well as longer-term feasibility use and the effect of the mouthpiece on sleep and quality of life.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Changes in Gait Velocity

  Gait velocity will be measured while walking forwards with and without the mouthpiece

  Baseline in-person visit

• Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest)

  Balance will be measured with the Mini-Balance Evaluation Systems Test (Mini-BESTest) with and without the mouthpiece. The assessment includes 14 items each of which is rated on a three-point scale (2: Normal, 1: Moderate, 0: Severe). The 14 item scores are summed for a total score. The range of scores is 0 to 28, and higher scores indicate better balance function.

  Baseline in-person visit

Secondary Outcomes (2)

• Changes in Parkinson Disease Sleep Scale

  Baseline and One month

• Changes in Parkinson Disease Questionnaire-39

  Baseline and One month

Study Arms (1)

Dental Mouthpiece

EXPERIMENTAL

Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans.

Device: Dental Mouthpiece

Interventions

Dental Mouthpiece DEVICE

Participants will complete motor tasks with and without the dental mouthpiece during the in-person baseline visit. They will also be asked to wear the mouthpiece for one month, and complete sleep and quality of life questionnaires before and after wearing the mouthpiece.

Dental Mouthpiece

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a diagnosis of idiopathic, typical Parkinson Disease according to the United Kingdom Brain Bank Criteria, Hoehn \& Yahr stages 1-3;
• stable Parkinson disease medications for the two weeks prior to baseline visit;
• be able to walk at least 10 meters at baseline with or without an assistive device;
• have their own teeth and/or dentures;
• be willing to try to wear a mouthpiece for one month;
• are over the age of 30; and
• provide written or verbal informed consent.

You may not qualify if:

• pre-existing medical conditions that would inhibit full participation in the study's tasks;
• absence of any dentition;
• cognitive impairments indicated by Mini Mental Status Exam (MMSE) score of \<24;
• freezing of gait which moderately or severely impacts walking; or
• current use of an oral appliance (e.g., a dental mouthpiece, retainer, or braces).

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine Program in Physical Therapy

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

• Lane H, Rose LE, Woodbrey M, Arghavani D, Lawrence M, Cavanaugh JT. Exploring the Effects of Using an Oral Appliance to Reduce Movement Dysfunction in an Individual With Parkinson Disease: A Single-Subject Design Study. J Neurol Phys Ther. 2017 Jan;41(1):52-58. doi: 10.1097/NPT.0000000000000160.

  PMID: 27977521 BACKGROUND

• Potter K, Brandfass K. The Mini-Balance Evaluation Systems Test (Mini-BESTest). J Physiother. 2015 Oct;61(4):225. doi: 10.1016/j.jphys.2015.04.002. Epub 2015 Jun 1. No abstract available.

  PMID: 26044345 BACKGROUND

• Jenkinson C, Fitzpatrick R, Peto V, Greenhall R, Hyman N. The Parkinson's Disease Questionnaire (PDQ-39): development and validation of a Parkinson's disease summary index score. Age Ageing. 1997 Sep;26(5):353-7. doi: 10.1093/ageing/26.5.353.

  PMID: 9351479 BACKGROUND

• Trenkwalder C, Kohnen R, Hogl B, Metta V, Sixel-Doring F, Frauscher B, Hulsmann J, Martinez-Martin P, Chaudhuri KR. Parkinson's disease sleep scale--validation of the revised version PDSS-2. Mov Disord. 2011 Mar;26(4):644-52. doi: 10.1002/mds.23476. Epub 2011 Feb 10.

  PMID: 21312275 BACKGROUND

• Moeller DR. Evaluation of a Removable Intraoral Soft Stabilization Splint for the Reduction of Headaches and Nightmares in Military PTSD Patients: A Large Case Series. J Spec Oper Med. 2013 Spring;13(1):49-54.

  PMID: 23526322 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

Limitations and Caveats

High number of withdrawals leading to smaller than expected number of participants to analyze outcomes over the one month period.

Results Point of Contact

• Title: Dr. Gammon Earhart
• Organization: Washington University School of Medicine

earhartg@wustl.edu

314-286-1407

Study Officials

• Gammon M Earhart, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Program in Physical Therapy

Model Details: All participants will receive a custom-fitted dental mouthpiece and asked to wear the mouthpiece for one month.

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: September 19, 2019
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: February 24, 2021
• Results First Posted: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)