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Study of the Application of Magnetic Fields for the Treatment of Parkinson's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by pico-tesla Magnetic Therapies, LLC.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier:
NCT00863226
First received: March 13, 2009
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Quality of Life
Device: Resonator Device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by pico-tesla Magnetic Therapies, LLC:

Primary Outcome Measures:
  • Change in PDQ-39 single index score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: March 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Resonator Device
    Application of Magnetic Fields Using the Resonator Device
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

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863226

Locations
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Mile High Research Center
Denver, Colorado, United States, 80218
CNI Movement Disorders Center
Englewood, Colorado, United States, 80113
United States, Florida
Suncoast Neuroscience Associates
St. Petersbury, Florida, United States, 33713
University of South Florida
Tampa, Florida, United States, 33612
United States, Michigan
Detroit Clinical Research Center
Novi, Michigan, United States, 48337
Sponsors and Collaborators
pico-tesla Magnetic Therapies, LLC
Investigators
Principal Investigator: Rajeev Kumar, MD
Principal Investigator: Jack Klapper, MD
Principal Investigator: Stephen H Schechter, MD
Principal Investigator: Olga Klepitskaya, MD
Principal Investigator: Steven Cohen, MD
Principal Investigator: Robert A Hauser, MD
  More Information

No publications provided

Responsible Party: pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier: NCT00863226     History of Changes
Other Study ID Numbers: 09026-01
Study First Received: March 13, 2009
Last Updated: December 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by pico-tesla Magnetic Therapies, LLC:
Quality of Life issues in Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 27, 2014