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

Quality of Life Clinical Trial

Official title:

A Randomized, Double-Blind, Sham-Stimulation Controlled Study of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Parkinson's Disease: Phase Three Clinical Trial Protocol

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00863226
• Other study ID #: 09026-01
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 13, 2009
• Last updated: December 13, 2011
• Start date: March 2009
• Est. completion date: January 2012

Study information

• Verified date: December 2011
• Source: pico-tesla Magnetic Therapies, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Quality of Life

Intervention

Device:
• Resonator Device
Application of Magnetic Fields Using the Resonator Device

Locations

Country	Name	City	State
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	Detroit Clinical Research Center	Novi	Michigan
United States	Suncoast Neuroscience Associates	St. Petersbury	Florida
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
pico-tesla Magnetic Therapies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PDQ-39 single index score		8 weeks	No