Clinical trial NCT00863226: Study of the Application of Magnetic Fields for the Treatment of Parkinson's Disease
Official title: A Randomized, Double-Blind, Sham-Stimulation Controlled Study of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Parkinson's Disease: Phase Three Clinical Trial Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Parkinson's Disease
Quality of Life
Keywords: Quality of Life issues in Parkinson's disease
Lead sponsor: pico-tesla Magnetic Therapies, LLC
Sponsor class: INDUSTRY
First posted: 2009-03-17
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if a device called the Resonator can help to improve aspects of health and quality of life that are relevant to patients with Parkinson's disease.

Detailed description: This clinical trial will evaluate a new non-invasive, non-significant risk, device therapy as an adjuvant symptomatic treatment for some of the signs and or symptoms of Parkinson's Disease (PD). The device utilizes patented technology involving extremely low level electromagnetic fields.

Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's Disease
* Stable optimized anti-PD drugs for at least 4 weeks
* PDQ-39 Summary Index between 15 and 45
* Ambulatory
* Willing to maintain regular medication regime throughout study
* Able to abstain from starting in new treatments to improve PD symptoms during course of study.
* No prior surgical interventions for Parkinson's Disease
* Non-demented
* Minimum of 30 years of age, but not older than 85
* Capable of giving full written consent

Exclusion Criteria:

* Atypical Parkinsonism such as progressive supranuclear palsy, multiple system atrophy, CBDG etc.
* Subjects may not have any of the following: active brain tumor, strokes, hydrocephalus, any other neurologic or non-neuro problem which may affect symptomatic expression of patients parkinsonism.
* Consumption of medications that can produce drug induced parkinsonism
* Chronic pain not associated with PD
* Current or past history of major psychiatric disturbance
* No typical or non-typical anti-psychotics for treatment of drug induced psychosis.
* Chronic fatigue
* Epilepsy or history of epilepsy
* Seizures or taking medication for epilepsy
* HIV or other autoimmune disorders
* History of ECT
* Uncontrolled hypertension
* Advanced pulmonary disease
* Unstable cardiac disease
* Prior surgical interventions for Parkinson's disease
* Prosthetics or implants comprised of ferrous metals
* Pacemaker, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain
* Pregnant, breast feeding or planning pregnancy prior to study end
* Dementia, developmental disability, psychiatric disorder or other cognitive impairment
* Any significant medical condition that may require alteration of medical therapy during the study, or major medical condition which may interfere with the study activity.

Primary outcomes:
measure: Change in PDQ-39 single index score
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Denver
country: United States
facility: Mile High Research Center
state: Colorado
city: Englewood
country: United States
facility: CNI Movement Disorders Center
state: Colorado
city: St. Petersbury
country: United States
facility: Suncoast Neuroscience Associates
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Novi
country: United States
facility: Detroit Clinical Research Center
state: Michigan
Study officials:
name: Rajeev Kumar, MD
role: PRINCIPAL_INVESTIGATOR
name: Jack Klapper, MD
role: PRINCIPAL_INVESTIGATOR
name: Stephen H Schechter, MD
role: PRINCIPAL_INVESTIGATOR
name: Olga Klepitskaya, MD
role: PRINCIPAL_INVESTIGATOR
name: Steven Cohen, MD
role: PRINCIPAL_INVESTIGATOR
name: Robert A Hauser, MD
role: PRINCIPAL_INVESTIGATOR
References: