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

Koç University24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson's Disease

Interventions

Electro-stimulationDEVICE

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Istanbul University

Istanbul, Turkey (Türkiye)

Koc University Hospital

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Change in the UPDRS Motor Score (Part III)

Evaluation of patients' disease level with UPDRS examination at the middle of the stimulation

Time frame: 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.

Time frame: 30 minutes after the stimulation is terminated.

Secondary Outcomes

Change in the gait and balance parameters (cadence)

cadence

Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters (Stride length)

Stride length in meters

Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters (Stride velocity)

Stride velocity in m/s

Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters

Arm Swing Rate

Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters

Arm Range of Motion

Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters

Sit to Stand Duration

Data from ClinicalTrials.gov

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Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters

Sit to Stand Peak Trunk Velocity

Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters

Sit to Stand Peak Trunk Angle

Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters

Leg Swing Rate

Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters

Leg Range of Motion

Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters

Turn to Sit Peak Turn Velocity

Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters

Turn-to-Sit Trunk Range of Motion in Sagittal Plane

Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters

Knee Range of Motion

Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters

Trunk Joint Angles

Time frame: 10 minutes after the stimulation is initiated.

Change in the gait and balance parameters (cadence)

cadence

Time frame: 30 minutes after the stimulation is terminated.

Change in the gait and balance parameters (Stride length)

Stride length in meters

Time frame: 30 minutes after the stimulation is terminated.

Change in the gait and balance parameters (Stride velocity)

Stride velocity in m/s

Time frame: 30 minutes after the stimulation is terminated.

Change in the gait and balance parameters

Arm Swing Rate

Time frame: 30 minutes after the stimulation is terminated.

Change in the gait and balance parameters

Arm Range of Motion

Time frame: 30 minutes after the stimulation is terminated.

Change in the gait and balance parameters

Sit to Stand Duration

Time frame: 30 minutes after the stimulation is terminated.

Change in the gait and balance parameters

Sit to Stand Peak Trunk Velocity

Time frame: 30 minutes after the stimulation is terminated.

Change in the gait and balance parameters

Sit to Stand Peak Trunk Angle

Time frame: 30 minutes after the stimulation is terminated.

Change in the gait and balance parameters

Leg Swing Rate

Time frame: 30 minutes after the stimulation is terminated.

Change in the gait and balance parameters

Leg Range of Motion

Time frame: 30 minutes after the stimulation is terminated.

Change in the gait and balance parameters

Turn-to-Sit Peak Turn Velocity

Time frame: 30 minutes after the stimulation is terminated.

Change in the gait and balance parameters

Turn-to-Sit Trunk Range of Motion

Time frame: 30 minutes after the stimulation is terminated.

Change in the gait and balance parameters

Knee Range of Motion

Time frame: 30 minutes after the stimulation is terminated.

Change in the gait and balance parameters

Trunk Joint Angles

Time frame: 30 minutes after the stimulation is terminated.