NCT03907007

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 29, 2019

Last Update Submit

March 9, 2020

Conditions

Parkinson Disease

Keywords

Neurostimulator

Outcome Measures

Primary Outcomes (24)

  • Stride length [m]

    Measurement through motion capture system

    Time Frame: Baseline

  • Stride length [m]

    Measurement through motion capture system

    Time Frame: 20 minutes after stimulation is initiated

  • Stride length [m]

    Measurement through motion capture system

    Time Frame: 40 minutes after stimulation is initiated

  • Stride length [m]

    Measurement through motion capture system

    Time Frame: 60 minutes after stimulation is initiated

  • Stride velocity [m/s]

    Measurement through motion capture system

    Time Frame: Baseline

  • Stride velocity [m/s]

    Measurement through motion capture system

    Time Frame: 20 minutes after stimulation is initiated

  • Stride velocity [m/s]

    Measurement through motion capture system

    Time Frame: 40 minutes after stimulation is initiated

  • Stride velocity [m/s]

    Measurement through motion capture system

    Time Frame: 60 minutes after stimulation is initiated

  • Turning Velocity [deg/s]

    Measurement through motion capture system

    Time Frame: Baseline

  • Turning Velocity [deg/s]

    Measurement through motion capture system

    Time Frame: 20 minutes after stimulation is initiated

  • Turning Velocity [deg/s]

    Measurement through motion capture system

    Time Frame: 40 minutes after stimulation is initiated

  • Turning Velocity [deg/s]

    Measurement through motion capture system

    Time Frame: 60 minutes after stimulation is initiated

  • Double Support Percentage during walking [%]

    Measurement through motion capture system

    Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes

  • Double Support Percentage during walking [%]

    Measurement through motion capture system

    Time Frame: 20 minutes after stimulation is initiated

  • Double Support Percentage during walking [%]

    Measurement through motion capture system

    Time Frame: 40 minutes after stimulation is initiated

  • Double Support Percentage during walking [%]

    Measurement through motion capture system

    Time Frame: 60 minutes after stimulation is initiated

  • Swing Phase Percentage during walking [%]

    Measurement through motion capture system

    Time Frame: Baseline

  • Swing Phase Percentage during walking [%]

    Measurement through motion capture system

    Time Frame: 20 minutes after stimulation is initiated

  • Swing Phase Percentage during walking [%]

    Measurement through motion capture system

    Time Frame: 40 minutes after stimulation is initiated

  • Swing Phase Percentage during walking [%]

    Measurement through motion capture system

    Time Frame: 60 minutes after stimulation is initiated

  • Stance Phase Percentage during walking [%]

    Measurement through motion capture system

    Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes

  • Stance Phase Percentage during walking [%]

    Measurement through motion capture system

    Time Frame: 20 minutes after stimulation is initiated

  • Stance Phase Percentage during walking [%]

    Measurement through motion capture system

    Time Frame: 40 minutes after stimulation is initiated

  • Stance Phase Percentage during walking [%]

    Measurement through motion capture system

    Time Frame: 60 minutes after stimulation is initiated

Study Arms (3)

Sole Medication

NO INTERVENTION

Monitoring under current prescribed medication

Combined stimulation & medication

ACTIVE COMPARATOR

Concurrent usage of stimulation with the prescribed medication

Device: Percutaneous electrical nerve stimulation

Sole Stimulation

ACTIVE COMPARATOR

Alternating usage of stimulation to the prescribed medication

Device: Percutaneous electrical nerve stimulation

Interventions

Percutaneous electrical nerve stimulationDEVICE

Stimulation and medication at the same instant

Also known as: Stimulation & Medication
Combined stimulation & medication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koc University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 33117256DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcutaneous Electric Nerve StimulationDosage Forms

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Yusuf O Cakmak, MD, PhD

    Otago University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 8, 2019

Study Start

December 1, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

March 10, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)