Inclusion Criteria

• PDQ-39 Summary Index score of 15 or greater
• Non-demented, as evidenced by a score of 26 or greater on the MMSE.
• Current diagnosis of Idiopathic Parkinson's disease made by the study PI according to the UK Parkinson’s Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria for PD, Steps 1 & 2. (Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson’s disease. A clinico-pathological study of 100 cases. JNNP 1992;55:181-184).


• Step 1, Diagnosis of Parkinsonian Syndrome
  
• Bradykinesia, plus:
• At least one of the following
• Muscular Rigidity
• 4-6 Hz rest tremor

Clinical features/presentations:

Bradykinesia (slowness of movements). The slowness in voluntary movement, including difficulty initiating movement and completing movement once in progress, and impaired ability to adjust the body's position. Examples include slow bending of the fingers when trying to form and inability to complete the fist formation action; slow shuffling stride (inability to lift the feet and legs sufficiently off the floor and to complete a full stride), finger tapping at 1 Hz compared with the typical 4 or 5 Hz, failure of the arms to swing while walking.

Related features include bradykinesia in the face ("mask face": reduced facial expression, paucity of blinks), decreased swallowing frequency and loss of voice volume and lack of intonation (monotonous, slowed speech).

Truncal and limb muscle rigidity. Rigidity, or stiff muscles, may produce muscle pain and contribute to an expressionless, mask-like face.

Resting tremor or postural tremor. Tremor in the hands, fingers, forearm, or foot that tend to occur when the limb is at rest but not when performing tasks. Tremor may occur in the mouth and chin as well.

Postural instability. Examine for postural instability by suddenly pulling at the shoulders of a standing patient while securing him or her from behind in order to determine the degree of retropulsion. Postural instability is a contributing factor in falls and injuries.

• Step 2 Exclusion criteria for Parkinson’s disease: The subject must not present with any of the following conditions:
• history of repeated strokes with stepwise progression of parkinsonian features
• history of repeated head injury
• history of definite encephalitis
• oculogyric crises
• neuroleptic treatment at onset of symptoms
• sustained remission
• strictly unilateral features after 3 years
• supranuclear gaze palsy
• cerebellar signs
• early severe autonomic involvement
• early severe dementia with disturbances of memory, language, and praxis
• Babinski sign
• presence of cerebral tumor or communication hydrocephalus on imaging study
• negative response to large doses of levodopa in absence of malabsorption
• MPTP exposure

AND THE

(i) Modified Hoeh-Yahr Stage 1-3 when on medication.

The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress. The scale allocates stages from 0 to 5 to indicate the relative level of disability. (Hoehn M, Yahr M (1967). "Parkinsonism: onset, progression and mortality." Neurology 17 (5): 427-42. PMID 6067254).

• STAGE 0 = No signs of disease
• STAGE 1 = Unilateral disease
• STAGE 1.5 = Unilateral plus axial involvement
• STAGE 2 = Bilateral disease, without impairment of balance
• STAGE 2.5 = Mild bilateral disease, with recovery on pull test
• STAGE 3 = Mild to moderate bilateral disease; some postural instability; physically independent
• STAGE 4 = Severe disability; still able to walk or stand unassisted
• STAGE 5 = Wheelchair bound or bedridden unless aided.
• All medical records pertaining specifically and exclusively to a subject’s PD treatment and medication management will be obtained from the subject’s PD treating physician.
• At the time of study enrollment, the subject, in the judgment of the PI, is determined to be stable on his or her current medical therapy regimen,, with no indications that a change in the current medication regimen is likely to be necessary over the next two months. In addition, a subject presently treated with carbidopa/levodopa, dopamine agonists, COMT inhibitors or MAOB inhibitors and other anti-PD drugs must have been on stable doses for at least 4 weeks prior to study enrollment.
• Subject is ambulatory.
• Willing and able to maintain his or her regular medication regimen, and not alter same throughout the course of the study. Note: subjects with early Parkinson’s disease may be on NO medication regimen IF the Principal Investigator determines the subject to be stable.
• Willing and able to abstain from partaking in new treatments to improve Parkinson's disease symptoms during the course of participation in the study. Such treatments include new medications (other than those already comprising their regular medication regimen), dietary/herbal supplements/minerals, physical therapy, rTMS, surgical procedures such as DBS, alternative therapies such as acupuncture, massage, or hypnotherapy.
• Willing and able to abstain from all new medications that could affect Parkinson's disease and/or any of its associated symptoms for the duration of the study. Specifically, these medications are:
• alpha-methyldopa
• metoclopramide
• neuroleptics: e.g. haloperidol, olanzapine, or risperidone
• reserpine and similar dopamine-depleting agents
• anti-emetics such as Compazine or reglan
• Adequate contraceptive measures for female subjects.
• Minimum of 30 years of age, but not older than 85.
• Capable of giving full written informed consent.

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Have you recently been diagnosed with Parkinson’s disease? Talk to your doctor about taking part in Pico-Tesla’s clinical trial for their new Resonator® device which is used for magnet pulse therapy. During the trial, a low strength magnetic field will be emitted around your body in order to test the effectiveness in diminishing the symptoms of Parkinson’s disease.

Clinical trials are now being held in Novi, Michigan, and Clearwater, Florida. Each location is easily accessible from neighboring major cities. Discuss the use of magnet therapy with your physician, and contact Pico-Tesla to find out more.