Effect of Auricular Stimulation on Locomotion in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effect of Auricular Stimulation on Locomotion in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03907007
• Other study ID #: Par-03
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: March 2020
• Source: Inventram
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Percutaneous electrical nerve stimulation
Stimulation and medication at the same instant
• Percutaneous electrical nerve stimulation
Stimulation is given without administering medication

Locations

Country	Name	City	State
Turkey	Koc University Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Inventram	Koç University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stride length [m]	Measurement through motion capture system	Time Frame: Baseline
Primary	Stride length [m]	Measurement through motion capture system	Time Frame: 20 minutes after stimulation is initiated
Primary	Stride length [m]	Measurement through motion capture system	Time Frame: 40 minutes after stimulation is initiated
Primary	Stride length [m]	Measurement through motion capture system	Time Frame: 60 minutes after stimulation is initiated
Primary	Stride velocity [m/s]	Measurement through motion capture system	Time Frame: Baseline
Primary	Stride velocity [m/s]	Measurement through motion capture system	Time Frame: 20 minutes after stimulation is initiated
Primary	Stride velocity [m/s]	Measurement through motion capture system	Time Frame: 40 minutes after stimulation is initiated
Primary	Stride velocity [m/s]	Measurement through motion capture system	Time Frame: 60 minutes after stimulation is initiated
Primary	Turning Velocity [deg/s]	Measurement through motion capture system	Time Frame: Baseline
Primary	Turning Velocity [deg/s]	Measurement through motion capture system	Time Frame: 20 minutes after stimulation is initiated
Primary	Turning Velocity [deg/s]	Measurement through motion capture system	Time Frame: 40 minutes after stimulation is initiated
Primary	Turning Velocity [deg/s]	Measurement through motion capture system	Time Frame: 60 minutes after stimulation is initiated
Primary	Double Support Percentage during walking [%]	Measurement through motion capture system	Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Primary	Double Support Percentage during walking [%]	Measurement through motion capture system	Time Frame: 20 minutes after stimulation is initiated
Primary	Double Support Percentage during walking [%]	Measurement through motion capture system	Time Frame: 40 minutes after stimulation is initiated
Primary	Double Support Percentage during walking [%]	Measurement through motion capture system	Time Frame: 60 minutes after stimulation is initiated
Primary	Swing Phase Percentage during walking [%]	Measurement through motion capture system	Time Frame: Baseline
Primary	Swing Phase Percentage during walking [%]	Measurement through motion capture system	Time Frame: 20 minutes after stimulation is initiated
Primary	Swing Phase Percentage during walking [%]	Measurement through motion capture system	Time Frame: 40 minutes after stimulation is initiated
Primary	Swing Phase Percentage during walking [%]	Measurement through motion capture system	Time Frame: 60 minutes after stimulation is initiated
Primary	Stance Phase Percentage during walking [%]	Measurement through motion capture system	Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Primary	Stance Phase Percentage during walking [%]	Measurement through motion capture system	Time Frame: 20 minutes after stimulation is initiated
Primary	Stance Phase Percentage during walking [%]	Measurement through motion capture system	Time Frame: 40 minutes after stimulation is initiated
Primary	Stance Phase Percentage during walking [%]	Measurement through motion capture system	Time Frame: 60 minutes after stimulation is initiated