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

An Open-label Extension Study for Subjects Previously Treated Either in Pilot I or Pilot II Studies of the Application of Magnetic Fields Using the Resonator for the Treatment of Parkinson's Disease.

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Resonator Device

• Study Type: Observational
• Enrollment (Actual): 18

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Previous participants enrolled in one of two prior pico-tesla Magnetic Therapies Resonator device studies using magnetic fields for treating Parkinson's Disease (PD) symptoms.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Active Resonator magnetic field therapy; Administration of active magnetic fields with the Resonator Device	Device: Resonator Device; active pico-tesla magnetic fields treatment for Parkinson's disease individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months	The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item quality of life questionnaire for patients with Parkinson's Disease (PD) that evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. The PDQ-39 Single Index (SI) score is the weighted addition of scores on all 8 dimension and ranges from 0 (no disease impact) to 100 (severe disease impact).	baseline and 11 months

Collaborators and Investigators

• Sponsor: pico-tesla Magnetic Therapies, LLC
• Investigators: Principal Investigator: Jerry I Jacobson, PhD., DMD., Pico-Tesla Magnetic Therapies, LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: October 22, 2008
• First Submitted That Met QC Criteria: March 16, 2009
• First Posted (Estimate): March 17, 2009

Study Record Updates

• Last Update Posted (Estimate): July 8, 2011
• Last Update Submitted That Met QC Criteria: June 9, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PD Ext