Study of the Application of Magnetic Fields for the Treatment of Parkinson's Disease

pico-tesla Magnetic Therapies

Status and phase

Unknown

Phase 3

Conditions

Quality of Life

Parkinson's Disease

Treatments

Device: Resonator Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT00863226

09026-01

Details and patient eligibility

About

The purpose of this study is to see if a device called the Resonator can help to improve aspects of health and quality of life that are relevant to patients with Parkinson's disease.

Full description

This clinical trial will evaluate a new non-invasive, non-significant risk, device therapy as an adjuvant symptomatic treatment for some of the signs and or symptoms of Parkinson's Disease (PD). The device utilizes patented technology involving extremely low level electromagnetic fields.

Enrollment

72 estimated patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Idiopathic Parkinson's Disease
Stable optimized anti-PD drugs for at least 4 weeks
PDQ-39 Summary Index between 15 and 45
Ambulatory
Willing to maintain regular medication regime throughout study
Able to abstain from starting in new treatments to improve PD symptoms during course of study.
No prior surgical interventions for Parkinson's Disease
Non-demented
Minimum of 30 years of age, but not older than 85
Capable of giving full written consent

Exclusion criteria

Atypical Parkinsonism such as progressive supranuclear palsy, multiple system atrophy, CBDG etc.
Subjects may not have any of the following: active brain tumor, strokes, hydrocephalus, any other neurologic or non-neuro problem which may affect symptomatic expression of patients parkinsonism.
Consumption of medications that can produce drug induced parkinsonism
Chronic pain not associated with PD
Current or past history of major psychiatric disturbance
No typical or non-typical anti-psychotics for treatment of drug induced psychosis.
Chronic fatigue
Epilepsy or history of epilepsy
Seizures or taking medication for epilepsy
HIV or other autoimmune disorders
History of ECT
Uncontrolled hypertension
Advanced pulmonary disease
Unstable cardiac disease
Prior surgical interventions for Parkinson's disease
Prosthetics or implants comprised of ferrous metals
Pacemaker, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain
Pregnant, breast feeding or planning pregnancy prior to study end
Dementia, developmental disability, psychiatric disorder or other cognitive impairment
Any significant medical condition that may require alteration of medical therapy during the study, or major medical condition which may interfere with the study activity.