Understanding FDA not Cleared for Parkinson's Syndrome

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Parkinson's Disease is a progressive neurodegenerative disorder that profoundly impacts the central nervous system.

Its characteristic motor symptoms arise from the critical depletion of dopamine, a vital neurotransmitter.

This depletion is directly linked to the death of a specific group of cells located deep within the brain, in an area known as the substantia nigra.


While the precise reason for this cell death remains unknown, its impact on dopamine levels is central to the disease's manifestation.


The hallmark motor deficits of Parkinson's include slowed physical movement (bradykinesia), muscle rigidity, involuntary resting tremors, postural instability, and gait disturbances. These challenging symptoms stem from the abnormal functioning of the basal ganglia, a complex collection of deep brain structures primarily responsible for controlling the automatic and precise aspects of movement without conscious effort. 

Normally, neurons within the basal ganglia release dopamine, which is crucial for seamless motor control.

In Parkinson's disease, either the release of dopamine or the function of its receptors is severely compromised.

As the disease advances, motor difficulties often extend to controlling essential functions like speech and swallowing.

Speech may become notably slow and soft, sometimes reducing to little more than a whisper as patients struggle to force air through their windpipes, which is necessary for vocal projection. 

Parkinson's disease affects an estimated 1-2% of the global population, with approximately 1 million patients in the U.S. alone. In Israel, although there isn't a centralized registry, estimates based on prevalence suggest between 60,000 and 100,000 patients. 

The average age of onset for Parkinson's is around 57-58 years, and its prevalence significantly increases with age.

Various drug therapies are currently available that aim to alleviate Parkinson's symptoms by artificially introducing dopamine into the body or mimicking its effects. 


While these medications can effectively ease symptoms, they often come with a range of side effects such as nausea (especially at the beginning of treatment), involuntary movements (dyskinesia), confusion, or hallucinations resulting from an overdose. 


In Summary

Parkinson's Disease is a progressive neurodegenerative disorder characterized by dopamine depletion and debilitating motor symptoms. 


While conventional drug therapies can alleviate symptoms, they often come with significant side effects and do not halt disease progression. 

Deep TMS emerges as a promising, non-invasive treatment option.

Curious about How BrainsWay Deep TMS® could transform your Health?

BrainsWay Deep TMS® offers innovative approaches not only for neurological and psychiatric conditions. 


Important disclaimer

BrainsWay Deep TMS® Treatment for Parkinson's Syndrome is not intended for individuals in the United States as it HAS NOT BEEN FULLY CLEARED by the FDA for safety and efficacy for these specific indications. 


 "It is important to note that while these specific indications may not be FDA-cleared in the United States, some BrainsWay Deep TMS® treatments for certain conditions may have received CE Mark approval in Europe, indicating compliance with European health, safety, and environmental protection standards. Always verify the regulatory status of any treatment in your specific region."