Effect Mechanism Investigation of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms

Inventram

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Electrical Stimulation; Other: Dry Needling Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03320681

Par-02

Details and patient eligibility

About

Effect Mechanism Investigation of a Wearable Electrostimulator for Rapid Alleviation of Parkinson's Disease Symptoms

Full description

Activation levels of interested regions of the brain will be measured through fMRI technique prior and after the dry needling and active stimulation applications.

Enrollment: 11 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: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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11 participants in 2 patient groups

Active Stimulation

Active Comparator group

Description:

Acupuncture needles will be inserted into the auricular zones and electrical stimulation will be given for 20 minutes.

Treatment:

Device: Electrical Stimulation

Dry Needling

Other group

Description:

Acupuncture needles will be inserted into the auricular zones for 20 minutes. However, no electrical stimulation will be given

Treatment:

Other: Dry Needling Stimulation