Clinical trial NCT03907007: Effect of Auricular Stimulation on Locomotion in Patients With Parkinson's Disease
Official title: Effect of Auricular Stimulation on Locomotion in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Neurostimulator
Lead sponsor: Inventram
Sponsor class: INDUSTRY
Collaborators: name: Koç University
First posted: 2019-04-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The effect of auricular stimulation on the locomotion capability in patients with Parkinson's Disease was investigated.

Detailed description: Effect of the auricular stimulation as a supplementary and alternative usage to Levodopa was investigated in this study. Clinical data were collected through motion capture system while the participants performed the clinical task asked by the investigators.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Parkinson's Disease
* H\&Y Stage \>= 1
* Existing bradykinesia symptoms
* Existence of one of the symptoms below
* Resting Tremor
* Rigidity
* Walking disorder

Exclusion Criteria:

* Cardiac Pacemaker
* Psychiatric diagnosis
* Irregular heart/respiration rate
* Pregnancy
* Alcohol consumption
* Cardiovascular disease history
* Wearing an electro-active prosthesis
* Brain surgery history
* Ongoing TENS/PENS therapy

Primary outcomes:
measure: Stride length [m]
timeFrame: Time Frame: Baseline
measure: Stride length [m]
timeFrame: Time Frame: 20 minutes after stimulation is initiated
measure: Stride length [m]
timeFrame: Time Frame: 40 minutes after stimulation is initiated
measure: Stride length [m]
timeFrame: Time Frame: 60 minutes after stimulation is initiated
measure: Stride velocity [m/s]
timeFrame: Time Frame: Baseline
measure: Stride velocity [m/s]
timeFrame: Time Frame: 20 minutes after stimulation is initiated
measure: Stride velocity [m/s]
timeFrame: Time Frame: 40 minutes after stimulation is initiated
measure: Stride velocity [m/s]
timeFrame: Time Frame: 60 minutes after stimulation is initiated
measure: Turning Velocity [deg/s]
timeFrame: Time Frame: Baseline
measure: Turning Velocity [deg/s]
timeFrame: Time Frame: 20 minutes after stimulation is initiated
measure: Turning Velocity [deg/s]
timeFrame: Time Frame: 40 minutes after stimulation is initiated
measure: Turning Velocity [deg/s]
timeFrame: Time Frame: 60 minutes after stimulation is initiated
measure: Double Support Percentage during walking [%]
timeFrame: Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
measure: Double Support Percentage during walking [%]
timeFrame: Time Frame: 20 minutes after stimulation is initiated
measure: Double Support Percentage during walking [%]
timeFrame: Time Frame: 40 minutes after stimulation is initiated
measure: Double Support Percentage during walking [%]
timeFrame: Time Frame: 60 minutes after stimulation is initiated
measure: Swing Phase Percentage during walking [%]
timeFrame: Time Frame: Baseline
measure: Swing Phase Percentage during walking [%]
timeFrame: Time Frame: 20 minutes after stimulation is initiated
measure: Swing Phase Percentage during walking [%]
timeFrame: Time Frame: 40 minutes after stimulation is initiated
measure: Swing Phase Percentage during walking [%]
timeFrame: Time Frame: 60 minutes after stimulation is initiated
measure: Stance Phase Percentage during walking [%]
timeFrame: Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
measure: Stance Phase Percentage during walking [%]
timeFrame: Time Frame: 20 minutes after stimulation is initiated
measure: Stance Phase Percentage during walking [%]
timeFrame: Time Frame: 40 minutes after stimulation is initiated
measure: Stance Phase Percentage during walking [%]
timeFrame: Time Frame: 60 minutes after stimulation is initiated
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Koc University Hospital
Study officials:
affiliation: Otago University
name: Yusuf O Cakmak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cakmak YO, Ozsoy B, Ertan S, Cakmak OO, Kiziltan G, Yapici-Eser H, Ozyaprak E, Olcer S, Urey H, Gursoy-Ozdemir Y. Intrinsic Auricular Muscle Zone Stimulation Improves Walking Parameters of Parkinson's Patients Faster Than Levodopa in the Motion Capture Analysis: A Pilot Study. Front Neurol. 2020 Oct 7;11:546123. doi: 10.3389/fneur.2020.546123. eCollection 2020.