Clinical trial NCT00862537: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: pico-tesla Magnetic Therapies, LLC
Sponsor class: INDUSTRY
First posted: 2009-03-17
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
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.

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.


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

Primary outcomes:
measure: Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months
timeFrame: baseline and 11 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: pico-tesla Magnetic Therapies, LLC
name: Jerry I Jacobson, PhD., DMD.
role: PRINCIPAL_INVESTIGATOR
References: