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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00862537
Recruitment Status : Completed
First Posted : March 17, 2009
Results First Posted : July 8, 2011
Last Update Posted : July 8, 2011
Sponsor:
Information provided by:
pico-tesla Magnetic Therapies, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment
Parkinson's Disease Device: Resonator Device

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Study Type : Observational
Actual Enrollment : 18 participants
Official 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.
Study Start Date : April 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862537


Sponsors and Collaborators
pico-tesla Magnetic Therapies, LLC
Investigators
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Principal Investigator: Jerry I Jacobson, PhD., DMD. pico-tesla Magnetic Therapies, LLC
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Responsible Party: pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier: NCT00862537    
Other Study ID Numbers: PD Ext
First Posted: March 17, 2009    Key Record Dates
Results First Posted: July 8, 2011
Last Update Posted: July 8, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases