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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: Placebo; Device: Electro-stimulation

• Registration Number: NCT02722824
• Lead Sponsor: Koç University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-03-06
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-30
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Wearable stimulators will be placed on the patients and controls without stimulation for 20 minutes
Sham	Electro-stimulation	An area out of the instrinsic auricular muscles region will be stimulated with the same parameters of the active group for 20 minutes
Active Stimulation	Electro-stimulation	Instrinsic auricular muscles will be stimulated for 20 minutes

Primary Outcome Measures

Name	Time	Method
Change in the UPDRS Motor Score (Part III)	30 minutes after the stimulation is terminated.	Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated.

Secondary Outcome Measures

Name	Time	Method
Change in the gait and balance parameters (Stride velocity)	30 minutes after the stimulation is terminated.	Stride velocity in m/s
Change in the gait and balance parameters (cadence)	30 minutes after the stimulation is terminated.	cadence
Change in the gait and balance parameters (Stride length)	30 minutes after the stimulation is terminated.	Stride length in meters
Change in the gait and balance parameters	30 minutes after the stimulation is terminated.	Trunk Joint Angles

Trial Locations

Locations (2)

Istanbul University; 🇹🇷 İstanbul, Turkey

Koc University Hospital; 🇹🇷 İstanbul, Turkey