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

NCT ID: NCT00863226

Last Updated: 2011-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease Quality of Life

Keywords

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Quality of Life issues in Parkinson's disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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Resonator Device

Application of Magnetic Fields Using the Resonator Device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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pico-tesla Magnetic Therapies, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rajeev Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Jack Klapper, MD

Role: PRINCIPAL_INVESTIGATOR

Stephen H Schechter, MD

Role: PRINCIPAL_INVESTIGATOR

Olga Klepitskaya, MD

Role: PRINCIPAL_INVESTIGATOR

Steven Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Robert A Hauser, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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University of Colorado Health Sciences Center

Aurora, Colorado, United States

Site Status

Mile High Research Center

Denver, Colorado, United States

Site Status

CNI Movement Disorders Center

Englewood, Colorado, United States

Site Status

Suncoast Neuroscience Associates

Saint Petersbury, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Detroit Clinical Research Center

Novi, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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09026-01

Identifier Type: -

Identifier Source: org_study_id