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

Phase 3

• Conditions: Parkinson's Disease; Quality of Life

• Registration Number: NCT00863226
• Lead Sponsor: pico-tesla Magnetic Therapies, LLC

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-13
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-17
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-13
• Last Update Posted: 2011-12-14
• Primary Completion: 2012-01
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in PDQ-39 single index score	8 weeks

Trial Locations

Locations (6)

Suncoast Neuroscience Associates; 🇺🇸 St. Petersbury, Florida, United States

University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States

Mile High Research Center; 🇺🇸 Denver, Colorado, United States

CNI Movement Disorders Center; 🇺🇸 Englewood, Colorado, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Detroit Clinical Research Center; 🇺🇸 Novi, Michigan, United States