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

Inventram

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Percutaneous electrical nerve stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03907007

Par-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Sole Medication

No Intervention group

Description:

Monitoring under current prescribed medication

Combined stimulation & medication

Active Comparator group

Description:

Concurrent usage of stimulation with the prescribed medication

Treatment:

Device: Percutaneous electrical nerve stimulation

Device: Percutaneous electrical nerve stimulation

Sole Stimulation

Active Comparator group

Description:

Alternating usage of stimulation to the prescribed medication

Treatment:

Device: Percutaneous electrical nerve stimulation

Device: Percutaneous electrical nerve stimulation