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

NCT00863226 | Unknown Phase 3

• 1 other identifier: 09026-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 6

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.

Conditions

Parkinson's Disease; Quality of Life

Keywords

Quality of Life issues in Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Change in PDQ-39 single index score

  8 weeks

Interventions

Resonator Device DEVICE

Application of Magnetic Fields Using the Resonator Device

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• pico-tesla Magnetic Therapies, LLC: lead

Study Sites (6)

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Location

Mile High Research Center

Denver, Colorado, 80218, United States

Location

CNI Movement Disorders Center

Englewood, Colorado, 80113, United States

Location

Suncoast Neuroscience Associates

Saint Petersbury, Florida, 33713, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Detroit Clinical Research Center

Novi, Michigan, 48337, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2009
• First Posted: March 17, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: December 14, 2011

Record last verified: 2011-12

Locations

US (6)