Clinical trial NCT04082663: Dental Appliance for Parkinson's Disease
Official title: Evaluating the Effects of a Removable Dental Mouthpiece on Symptoms Associated With Parkinson's
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive a custom-fitted dental mouthpiece and asked to wear the mouthpiece for one month.
Primary purpose: TREATMENT

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.

Detailed description: The investigators are conducting a pilot study with participants who have been diagnosed with Parkinson disease recruited from the community. Participants will attend one in-person visit and be custom fitted with a dental mouthpiece. Participants will be asked to wear the mouthpiece as much as possible for one month including while sleeping and during the day, except while eating.

Participants will be asked to return for a second in-person visit to repeat gait and balance (motor) measures.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Changes in Gait Velocity
timeFrame: Baseline in-person visit
measure: Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest)
timeFrame: Baseline in-person visit
Secondary outcomes:
measure: Changes in Parkinson Disease Sleep Scale
timeFrame: Baseline and One month
measure: Changes in Parkinson Disease Questionnaire-39
timeFrame: Baseline and One month
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine Program in Physical Therapy
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Gammon M Earhart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.