Thursday, April 03, 2025
FDA is taking an initiative to authorize the marketing of Portable Neuromodulation Stimulator (PoNS) for Multiple Sclerosis patients which can help patients with their motor deficit to some extent.
Are you aware of the condition called Multiple Sclerosis? This is one of the leading causes of neurological disability in many patients worldwide. It basically affects the nerve lining sheath. When this nerve sheath gets worn out, it results in electric shock, and pain may affecting their functions like talking, walking, and writing. Just imagine, the outer covering of the nerve sheath gets worms out causing intense damage to the actual nerve. It can get really painful and affect your walking and speech as the communication between the brain and body is carried by nerves. In the end, the nervous system gets disrupted resulting in slow walking and delayed speech. As age advances, the person suffering from Multiple Sclerosis gets further deteriorated.
FDA comes to help the patients with Multiple Sclerosis
On 26th March 2021, the Food and Drug Administration (FDA) authorized the marketing of a device that can help patients of Multiple Sclerosis with gait deficit with mild to moderate symptoms. The device is to be used by a prescription only as an adjunct to supervise exercise training programs in patients with Multiple Sclerosis at age 22 or older. The device is called Portable Neuromodulation Stimulator (PoNS) is a neuromuscular stimulator which helps generate electrical impulses or trigeminal and facial nerve via the tongue to provide treatment for motor deficit problems.
What is Multiple Sclerosis?
Multiple sclerosis is a chronic disease of the central nervous system. It is an autoimmune disorder, a condition in which the body mistakenly attacks its own healthy cells. Multiple Sclerosis is an unpredictable disease that affects people differently. The symptoms may vary from patient to patient and each may depend upon the area of damage. Multiple Sclerosis is the second cause of neurological disease and disability, after trauma. It affects more men than women.
The real science behind Multiple Sclerosis
As the name suggests, there is sclerosis or degradation of the outer sheath of the nerve which is also known as the myelin sheath. Myelin sheath is the outer fatty layer of the nerve. This myelin sheath protects the nerve fibers by providing a shield to the actual nerve. In Multiple Sclerosis , the myelin sheath is destroyed in many years affecting their functioning. This loss of myelin forms scar tissue called sclerosis. When the nerves are damaged in this way, they conduct electrical impulses to and from the brain.
Causes for Multiple Sclerosis
Autoimmune causes Infectious agents such as virus Environmental factors Genetic factorsSymptoms of Multiple Sclerosis
The symptoms of Multiple Sclerosis are unpredictable. They may be mild or severe, short-term or long-lasting. Theory may appear in different combinations, dispensing on the area of the nervous system affected. The following are the most common symptoms of Multiple Sclerosis. But each person may have different symptoms.
Blurred or double vision Red or green color distortion Pain or loss of vision because of swelling of the optic nerve Trouble walking An abnormal feeling such as numbness or pricking sensation of pins and needles Muscle weakness in arms and legs Difficulty in coordination while walking and standing Spasticity: Involuntary increased tone of muscles Stiffness Of muscles Spasm of muscles Fatigue on physical activity Constant tiredness that does not go away Loss of feeling Speech problems: delayed of slurred speech Tremors Dizziness Hearing loss Bowel and Bladder problem Depression Changes in sexual function Thinking inability or cognitive function Difficulty in focus and attention Memory loss Poor judgmentAll you need to know about the Portable Neuromodulation Stimulator (PoNS) for Multiple Sclerosis patients
The FDA assesses the safety and effectiveness of Portable Neuromodulation Stimulator (PoNS) for Multiple Sclerosis patients through 2 clinical studies and retrospective analysis of the Real-World Clinical Data (RWD). The FDA is granted marked authorization of Portable Neuromodulation Stimulator (PoNS) for Multiple Sclerosis patients to Helius Medical Inc.
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