Evaluation of Long-term Effect of Resonator Therapy on Parkinson's Disease (PD)

NCT ID: NCT00862537

Last Updated: 2011-07-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-04-30

Brief Summary

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An extension study for subjects with prior participation in previous resonator studies using low level magnetic fields to treat some of the symptoms of idiopathic Parkinson's Disease.

Detailed Description

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Conditions

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Parkinson's Disease

Study Groups

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Active Resonator magnetic field therapy

Administration of active magnetic fields with the Resonator Device

Resonator Device

Intervention Type DEVICE

active pico-tesla magnetic fields treatment for Parkinson's disease individuals

Interventions

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Resonator Device

active pico-tesla magnetic fields treatment for Parkinson's disease individuals

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Prior participation in pico-tesla pilot studies: NCT00779155 \& NCT00863226
* Willing and able to abstain from partaking in non-essential new treatments for Parkinson's disease symptoms during the course of participation of the study.
* Will and able to abstain from all non-essential new medications that could affect PD and/or any of its associated symptoms for the duration of the study.
* Willing to notify the investigator right away of any changes in medication use or therapies that is prescribed and deemed necessary by the subjects physicians.
* Adequate contraceptive measures for female subjects
* Capable of giving full written informed consent

Exclusion Criteria

* Not a participant in IRC#'s 07102 or 07021
* No active brain tumors, strokes, hydrocephalus
* Chronic pain not associated with PD
* Any other condition which might prevent subject from comfortably sitting for 1.5 hours
* Consumption of medications that can produce Parkinsonism type symptoms
* Major psychiatric disturbance
* Epilepsy
* HIv and other autoimmune disorders
* Cancer within last 2 years
* History of ECt
* Diabetic neuropathy
* Uncontrolled HTN
* Advanced Pulmonary disease
* Known heart conditions such as repetitive history of cardiac arrythmias
* Previous surgeries for PD
* Prosthetics comprised of ferrous materials
* Stents, only where there is also cardiac arrythmias, CHF, advanced valvular stenosis, unstable vital signs, extensive ischemic damage to heart muscle as a result of one or more heart attacks.
* Pacemakers
* Uncontrolled, unstable, or untreated medical illnesses which might potentially significantly affect the patient's health in the opinion of the investigator
* Consumption of more than 21 alcoholic drinks per week
* Pregnant, breast feeding or planning pregnancy
* Developmental disability or cognitive impairment
* Inability to maintain regular medication regime
* Inability to abstain from partaking in new non-essential PD tx., or medications
* Not willing to report physician mandated changes in medication and/or treatment
Minimum Eligible Age

30 Years

Maximum Eligible Age

82 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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pico-tesla Magnetic Therapies, LLC

Principal Investigators

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Jerry I Jacobson, PhD., DMD.

Role: PRINCIPAL_INVESTIGATOR

pico-tesla Magnetic Therapies, LLC

Other Identifiers

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PD Ext

Identifier Type: -

Identifier Source: org_study_id

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