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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

Tracking Information
First Submitted Date October 22, 2008
First Posted Date March 17, 2009
Results First Submitted Date May 13, 2011
Results First Posted Date July 8, 2011
Last Update Posted Date July 8, 2011
Study Start Date April 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 9, 2011)
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).
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Long-term Effect of Resonator Therapy on Parkinson's Disease (PD)
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.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Parkinson's Disease
Intervention Device: Resonator Device
active pico-tesla magnetic fields treatment for Parkinson's disease individuals
Study Groups/Cohorts Active Resonator magnetic field therapy
Administration of active magnetic fields with the Resonator Device
Intervention: Device: Resonator Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 9, 2011)
18
Original Estimated Enrollment
 (submitted: March 16, 2009)
23
Actual Study Completion Date April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 82 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00862537
Other Study ID Numbers PD Ext
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party pico-tesla Magnetic Therapies, LLC
Study Sponsor pico-tesla Magnetic Therapies, LLC
Collaborators Not Provided
Investigators
Principal Investigator: Jerry I Jacobson, PhD., DMD. pico-tesla Magnetic Therapies, LLC
PRS Account pico-tesla Magnetic Therapies, LLC
Verification Date June 2011