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

Primary Purpose

Parkinson's Disease, Quality of Life

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Resonator Device

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Quality of Life issues in Parkinson's disease

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

University of Colorado Health Sciences Center
Mile High Research Center
CNI Movement Disorders Center
Suncoast Neuroscience Associates
University of South Florida
Detroit Clinical Research Center

Outcomes

Primary Outcome Measures

Change in PDQ-39 single index score

Secondary Outcome Measures

Full Information

NCT ID

NCT00863226

First Posted

March 13, 2009

Last Updated

December 13, 2011

Sponsor

pico-tesla Magnetic Therapies, LLC

1. Study Identification

Unique Protocol Identification Number

NCT00863226

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Unknown status

Study Start Date

March 2009 (undefined)

Primary Completion Date

January 2012 (Anticipated)

Study Completion Date

January 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

pico-tesla Magnetic Therapies, LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease, Quality of Life

Keywords

Quality of Life issues in Parkinson's disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Resonator Device

Intervention Description

Application of Magnetic Fields Using the Resonator Device

Primary Outcome Measure Information:

Title

Change in PDQ-39 single index score

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: