Efficacy of a Non-invasive Device for Alleviation of Parkinson's Disease Symptoms

Efficacy Investigation of a Non-invasive Wearable Electrostimulation Device for Alleviation of Parkinson's Disease Symptoms

Investigation efficacy of a non-invasive wearable electrostimulator device where the supplementary motor area, premotor area and/or subthalamic nucleus are stimulated bilaterally and extracranially.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Other: Placebo; Device: Electro-stimulation

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey
    • Istanbul University
  • İstanbul, Turkey
    • Koc University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of Parkinson's Disease
• H&Y Stage >= 2
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Wearable stimulators will be placed on the patients and controls without stimulation for 20 minutes	Other: Placebo
Experimental: Active Stimulation; Instrinsic auricular muscles will be stimulated for 20 minutes	Device: Electro-stimulation
Sham Comparator: Sham; An area out of the instrinsic auricular muscles region will be stimulated with the same parameters of the active group for 20 minutes	Device: Electro-stimulation
No Intervention: Passive Control; Only the electrodes of the wearable stimulators will be inserted but there will not be electrostimulation for 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the UPDRS Motor Score (Part III)	Evaluation of patients' disease level with UPDRS examination at the middle of the stimulation	10 minutes after the stimulation is initiated.
Change in the UPDRS Motor Score (Part III)	Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated.	30 minutes after the stimulation is terminated.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the gait and balance parameters (cadence)	cadence	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters (Stride length)	Stride length in meters	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters (Stride velocity)	Stride velocity in m/s	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters	Arm Swing Rate	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters	Arm Range of Motion	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters	Sit to Stand Duration	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters	Sit to Stand Peak Trunk Velocity	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters	Sit to Stand Peak Trunk Angle	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters	Leg Swing Rate	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters	Leg Range of Motion	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters	Turn to Sit Peak Turn Velocity	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters	Turn-to-Sit Trunk Range of Motion in Sagittal Plane	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters	Knee Range of Motion	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters	Trunk Joint Angles	10 minutes after the stimulation is initiated.
Change in the gait and balance parameters (cadence)	cadence	30 minutes after the stimulation is terminated.
Change in the gait and balance parameters (Stride length)	Stride length in meters	30 minutes after the stimulation is terminated.
Change in the gait and balance parameters (Stride velocity)	Stride velocity in m/s	30 minutes after the stimulation is terminated.
Change in the gait and balance parameters	Arm Swing Rate	30 minutes after the stimulation is terminated.
Change in the gait and balance parameters	Arm Range of Motion	30 minutes after the stimulation is terminated.
Change in the gait and balance parameters	Sit to Stand Duration	30 minutes after the stimulation is terminated.
Change in the gait and balance parameters	Sit to Stand Peak Trunk Velocity	30 minutes after the stimulation is terminated.
Change in the gait and balance parameters	Sit to Stand Peak Trunk Angle	30 minutes after the stimulation is terminated.
Change in the gait and balance parameters	Leg Swing Rate	30 minutes after the stimulation is terminated.
Change in the gait and balance parameters	Leg Range of Motion	30 minutes after the stimulation is terminated.
Change in the gait and balance parameters	Turn-to-Sit Peak Turn Velocity	30 minutes after the stimulation is terminated.
Change in the gait and balance parameters	Turn-to-Sit Trunk Range of Motion	30 minutes after the stimulation is terminated.
Change in the gait and balance parameters	Knee Range of Motion	30 minutes after the stimulation is terminated.
Change in the gait and balance parameters	Trunk Joint Angles	30 minutes after the stimulation is terminated.

Collaborators and Investigators

• Sponsor: Koç University
• Collaborators: Istanbul University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 6, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Actual): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: motor symptoms
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Par-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED