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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–82 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resonator Device

Device

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

Primary outcomes

Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months

Time frame: baseline and 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).

Sponsors and collaborators

Lead sponsor

pico-tesla Magnetic Therapies, LLC

Industry

Registry information

Official study title

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.

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Mar 17, 2009
Registry last updated: Jul 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed