Study Indication and Rationale, Theory of Mechanism of Operation, & Supporting Materials


The Resonator™ device uses electro-magnetic stimulation in order to relieve symptoms of a disorder or disease.


 

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Currently Available Treatments

Presently, there is no cure for Parkinson's disease. There are a number of medications approved by FDA to alleviate Parkinson's disease symptoms, as well as surgical techniques and a surgically implanted device indicated to lessen tremors and/or dyskinesias.


Medications

Mainstay of Parkinson's Therapy
Sinemet®: Levodopa and carbidopa combined is considered the mainstay of Parkinson's therapy. Levodopa is rapidly converted into dopamine by the enzyme dopa decarboxylase (DDC), which is present in the central and peripheral nervous systems. Much of levodopa is metabolized before it reaches the brain.

Carbidopa inhibits DDC. Combining levodopa with carbidopa increases the amount of levodopa that reaches the brain.

Side effects include gastrointestinal distress, especially early in treatment, low blood pressure (hypotension), and abnormal movements (dyskinesias). Depression, confusion, and visual hallucinations also may occur, especially in the elderly.

Dopamine Agonists
Dopamine agonists mimic dopamine's function in the brain and are used primarily as adjuncts to levodopa/carbidopa therapy. They can be used as monotherapy but are generally less effective in controlling symptoms. Dopamine agonists are: Bromocriptine (Parlodel®), Pramipexole (Mirapex®) and Ropinirole (Requip®).

Side effects are similar to those produced by levodopa.

Amantadine (Symmetryl®) is approved by the FDA for prevention of influenza. The mechanism by which amantadine results in symptomatic anti-Parkinson benefit is uncertain, but hypothesized to be due to a blockade of NMDA-type glutamate receptors.

Side effects include mottling of the skin, edema, confusion, blurred vision, insomnia, and anxiety.

MAO-B Inhibitors
Dopamine is oxidized by monoamine oxidase B (MAO-B). Selegiline (Carbex®) and rasagiline inhibit MAO-B, increasing the amount of available dopamine in the brain. MAO-B inhibitors boost the effects of levodopa.

Side effects may include nausea, dizziness, abdominal pain, confusion, hallucinations, and dry mouth.

Anticholinergics
Anticholinergics reduce the relative overactivity of the neurotransmitter acetylcholine. This class of drugs is most effective in the control of tremor,. Anticholinergics include Benztropine mesylate (Cogentin®), Biperiden (Akineton®), Diphenhydramine (Benadryl®) and Trihyxyphenidyl (Artane®).

Side effects include dry mouth, blurred vision, constipation, and urinary retention.

COMT (catechol-O-methyl transferase) Inhibitors
COMTs are a of Parkinson's medications that augment levodopa therapy by inhibiting the COMT enzyme, which metabolizes levodopa before it reaches the brain. Inhibiting COMT increases the amount of levodopa that enters the brain. These drugs are only effective when used with levodopa. COMTs include Entacapone (Comtan®) and Tolcapone (Tasmar®).

Side effects include vivid dreams, visual hallucinations, nausea, sleep disturbances, daytime drowsiness, headache, and dyskinesias.

Stalevo®
Carbidopa, levodopa, and entacapone are combined in Stalevo®, which is indicated for patients experiencing motor fluctuations.

Side effects of Stalevo® include dyskinesias and nausea, abdominal pain, constipation, diarrhea, discolored urine, dizziness, fatigue, hallucinations and hyperkinesias.

Surgery

Surgery is considered as a means of controlling Parkinson's disease symptoms and improving quality of life when medications result in inadequate benefit or patients have disabling motor fluctuations and/or dyskinesias.

There are two types of surgical procedures in clinical use for the treatment of Parkinson's disease:

Ablative Surgery
Ablative surgery involves destroying a small target within the brain important in the generation of symptoms of Parkinson's disease by inserting a heated probe or electrode resulting in focal tissue destruction. Major complications include intracerebral hemorrhage, infection, and inadequate or lack of benefit. In Parkinson's disease, the globus pallidus may be targeted (pallidotomy) to improve motor fluctuations and dyskinesias, usually predominately contralateral to the lesion. Alternatively, the thalamus may be targeted (thalamotomy) to improve contralateral tremor.

Deep Brain Stimulation (DBS)
In DBS, the subthalamic nucleus, globus pallidus, or thalamus is chronically stimulated by means of a permanently implanted electrode connected via a wire running beneath the skin to a stimulator and battery pack in the patient's chest. Potential adverse effects include intracerebral hemorrhage, hardware breakage or malfunction, hardware infection, etc. DBS may be performed bilaterally more safely than ablative surgery with a greater beneficial effect for the patient. Postoperatively, patients commonly require extensive follow-up visits in order to program the stimulator and the stimulator battery must be periodically replaced approximately every 3-7 years depending on usage.


Complementary Treatments

Physical therapy is commonly prescribed to help strengthen and tone muscles and improve range of motion, thus building body strength, and improving balance and gait. However, there is little class A evidence to support this practice.


 
 

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The Resonator™ device is an Investigational Device limited by Federal (or United States)
law to investigational use. The Resonator™ device is not for sale, nor is the Magneceutical®
Therapy generally available outside of Investigational Review Board (IRB) approved clinical studies.

 
 

Physicians located in Colorado, Michigan, and Florida, who have patients living with Parkinson’s disease, should know that Pico-Tesla Magnetic Therapies are currently conducting clinical trials in those three states. These trails will be used to test the efficacy of the Resonator® device which is used for pulsed magnetic therapy in treating Parkinson’s patients. This is a paid clinical trial for all patients who qualify for and complete the procedure.

All locations where these clinical trials are being held are in close proximity to major cities in each state. Any interested party can contact Pico-Tesla for more information.