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

Koç University

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: Electro-stimulation; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02722824

Par-01

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Wearable stimulators will be placed on the patients and controls without stimulation for 20 minutes

Treatment:

Other: Placebo

Active Stimulation

Experimental group

Description:

Instrinsic auricular muscles will be stimulated for 20 minutes

Treatment:

Device: Electro-stimulation

Sham

Sham Comparator group

Description:

An area out of the instrinsic auricular muscles region will be stimulated with the same parameters of the active group for 20 minutes

Treatment:

Device: Electro-stimulation

Passive Control

No Intervention group

Description:

Only the electrodes of the wearable stimulators will be inserted but there will not be electrostimulation for 20 minutes