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

Parkinson's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862537
• Other study ID #: PD Ext
• Status: Completed
• Phase: N/A
• First received: October 22, 2008
• Last updated: June 9, 2011
• Start date: April 2008
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: pico-tesla Magnetic Therapies, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 82 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Resonator Device
active pico-tesla magnetic fields treatment for Parkinson's disease individuals

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
pico-tesla Magnetic Therapies, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No