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Official Study Title: A Randomized, Double-Blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. Sham-Stimulation Controlled Study of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Parkinson's Disease:  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. Phase Three Clinical Trial  Clinical Trial (Clinical Study)A scientific study involving human participants to determine the safety and efficacy of new therapies or new ways of using known treatments. Protocol
Sponsor: pico-tesla Magnetic Therapies, LLC
Clinicaltrials.gov ID: NCT00863226
Study ID: 09026-01

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 people with PD. The results of two pilot studies suggest improvement across many different testing scales involving motor function, non-motor symptoms  Non-Motor SymptomsContribute to severe disability and impaired quality of life in advanced Parkinson's disease. Symptoms include anxiety, depression, cognitive mood swings, dementia, constipation, pain, genitourinary problems, sudden drop in blood pressure upon standing (orthostatic hypotension), excessive sweating, and sleep disturbances, sense of smell, vision, memory, weight loss, psychosis, hallucinations, and loss of energy. and quality of life issues.  Due to these favorable results, this clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. trial was designed. 

The ResonatorTM is a non-invasive, non-significant risk device that puts out extremely low-level electro-magnetic fields, it is intended to be an adjuvant therapy  TherapyAnother word for “treatment”. (not replacing medication).  The participant would sit in a chair on a low level platform with the coils on both sides, nothing would be touching the person during their treatment time.  People generally do not “feel” anything while being treated.  Treatment would be for one and a half hours, three times a week for eight weeks, a total of 24 treatments.

In this trial, participants will complete questionnaires for sleepiness, fatigue, non-motor symptoms and depression as well as objective testing  and rating of motor symptoms  Motor SymptomsThe physical symptoms of PD, such as balance, rigidity, tremor, freeze attacks, involuntary movements (dyskinesia), slowness of movement (bradykinesia), walking/gait, postural difficulties*, writing difficulty, swallowing difficulty* (dysphagia), muscle pain*, masked face*, speech problems* and general loss of motor skills. by the physician or other healthcare professional.  This testing is done at baseline  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. (prior to treatment phase), once during the eight week treatment phase, at conclusion of treatment and every four weeks for three months after treatment has stopped.

Study Phase

Phase 3
What is a study phase?

Symptoms Addressed: Movement and Non-movement

General PD symptoms

Time Commitment

• Less than six months
• 2 qualification visits, Treatment phase: 1½ hours, 3 times weekly for 8 weeks (24 treatment sessions), 4 post treatment visits

Eligibility

• Minimum Age: 30
• Maximum Age: 85
• Gender(s) Accepted: Either

Inclusion Criteria

• PD diagnosis
• Have been on stable optimized anti-PD drugs for at least 4 weeks
• Must be mobile
• 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 PD
• Absence of dementia
• Capable of giving full written consent
  

Exclusion Criteria

• Atypical Parkinsonism such as progressive supranuclear palsy,  Progressive Supranuclear Palsy, PSPA rare brain disorder diagnosed by the identification of early gait instability and difficulty moving the eyes. PSP is often misdiagnosed because some of its symptoms are very much like those of PD. Although PSP gets progressively worse and there is no effective treatment for it, the disease itself is not directly life-threatening. multiple system atrophy, CBDG etc.
• Participants 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 the person’s 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.  PsychosisA loss of contact with reality often accompanied by hallucinations. Psychosis can be caused by some PD medications and is more common in patients with advanced Parkinson's.
• Chronic fatigue
• Epilepsy or history of epilepsy or seizures or taking medication for epilepsy
• HIV or other autoimmune disorders
• History of ECT (electroconvulsive therapy)
• Uncontrolled hypertension (high blood pressure)
• Advanced pulmonary disease
• Unstable cardiac disease
• Prior surgical interventions for Parkinson's disease
• Metal/iron prosthetics or implants comprised
• 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,  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality. developmental disability, psychiatric disorder or other cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. 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.

Enrollment

Expected Enrollment: 72 (US)
Date Enrollment Began: Mar 2009
Date Enrollment Ends: Mar 2010
Last Updated Date: Aug 21 2009
Trial Post Date: Aug 21 2009
Website: http://clinicaltrials.gov/ct2/show/NCT00863226?term=NCT00863226&rank=1

Primary Contacts and Locations

Colorado

• CNI Movement Disorders Center
  Englewood, CO 80113
  USA
  
• CNI Movement Disorders Center
  Englewood, CO 80113
  USA
  
• Rajeev Kumar, MD — Principle Investigator
  CNI Movement Disorders Center
  Englewood, CO 80113
  USA