Enrollment Completed in Pilot Study for Parkinson’s Disease Treatment

Stimvia has finished enrolling patients in a pilot study for Parkinson’s disease (PD) and essential tremor (ET) treatment. Trial participants will be using the company’s URIS device, which employs a new method called peroneal neuromodulation (eTNM) for deep brain stimulation.

The company is following up with a pilot study in response to previous clinical trials that showed the URIS device is one of the most effective non-invasive technologies in treating central nervous system-related diseases. The study assesses the positive impact on the symptoms of patients with PD or ET disorders, as well as the treatment’s influence on their quality of life.
 
Twenty-four patients meeting specific criteria are participating in the study, with half suffering from essential tremor and the other half diagnosed with Parkinson’s disease. For six weeks, patients will use the URIS device for 30-minute stimulation sessions daily. Following this phase, patients will go six weeks without stimulation, during which they will continue to be monitored to assess whether any positive effects persist after the treatment has ended.
 
It is estimated that 1 million U.S. residents are affected by Parkinson’s disease, while there are more than 10 million patients suffering from it worldwide. Parkinson’s disease is the second most common neurodegenerative disorder after Alzheimer’s disease, and is characterized by movement disorders, muscle stiffness, resting tremors, and issues with stability and walking. “Patients with Parkinson’s disease are typically treated with medications designed to increase dopamine levels in the brain. However, these drugs cannot prevent the progression of the disease. After a few years of use, it often happens that the drugs no longer work as intended,” said prof. David Skoloudik, M.D., Ph.D., study leader and vice dean for Science and Research at the Medical Faculty of Ostrava University. “This is why surgical solutions, involving the implantation of a neurostimulator under the patient’s collarbone and the insertion of electrodes into specific areas of the brain, are sometimes necessary. Like any surgery, this procedure carries significant risks. Treatment with URIS technology, on the other hand, is non-invasive and operates on the principle of neuromodulation, a new approach potentially applicable to many neurological diseases,” 

Stimvia and the URIS technology have already demonstrated high effectiveness in the treatment of overactive bladder. “The essence of our previous success lies in the specific method of peroneal neuromodulation. Although the classical technique of electrical neurostimulation has been known for a long time, URIS technology distinguishes itself with extremely precise stimulation of the peroneal nerve and the ability to deliver the necessary signal directly to the patient’s brain. Other non-invasive neurostimulation methods cannot achieve this. The electrical stimulation in the brain activates areas that are suppressed and, conversely, suppresses the activity of regions that exhibit excessive activity. The success in the pilot study for the treatment of Parkinson’s disease and essential tremor would confirm this central effect for us,” Stimvia CEO Lukas Doskocil stated.
 
The results of the pilot study are expected to be available in the first half of this year. If the URIS technology proves to have a positive impact on the treatment of patients with PD or ET, Stimvia plans to invest in subsequent clinical trials to confirm the effectiveness and safety of the entire method. 
 
Doskocil founded Stimvia in 2014 under the name Tesla Medical. The company’s activities were based on the preparatory phase of a project at the Second Faculty of Medicine, Charles University in Prague, which focused on the treatment of overactive bladder. Following this, several years of research were conducted under the guidance of the Stimvia team, leading to a series of clinical studies that propelled the technology to a new level. The result was the development of a unique device called URIS, utilizing peroneal neuromodulation technology (eTNM), which, for the first time ever, allows non-invasive stimulation of deep brain structures where the origin of many chronic diseases lies. Key technological components and methods of Stimvia are currently protected by more than 100 international patents within the EU, Japan, Russia, and the United States. Additionally, the company boasts one of the most prestigious certifications from the German institution TÜV SÜD.