tES Device for Parkinson's Disease

This trial tests a new device called Sphere V3.0 to help people with Parkinson's disease manage movement problems like tremors and stiffness. The device delivers gentle electrical signals to the scalp and is used at home for short daily sessions. The study aims to determine if these treatments can reduce symptoms and if improvements persist after treatment ends. Participants should have Parkinson’s, maintain stable medication for at least 4 weeks, and be comfortable using video calls and online tools. All participants will use the active device, and past tests have shown no serious side effects. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

The trial requires that participants have a stable medication regimen for at least 4 weeks before joining, so you should not stop taking your current medications.

Research has shown that the Sphere V3.0 device, which stimulates the brain non-surgically, was tested on over 250 people in earlier studies. Importantly, these studies reported no serious side effects, suggesting the device is generally safe for users. It sends gentle electrical signals to the scalp to help improve movement problems related to Parkinson's disease. Although researchers continue to study the device, the absence of serious side effects in past trials indicates promising safety for humans.¹²³⁴⁵

Unlike the standard treatments for Parkinson's disease, which often include medications like Levodopa and dopamine agonists that focus on managing symptoms, the Sphere V3.0 device offers a new approach through brain stimulation. Sphere V3.0 uses a method called amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS) to target specific motor cortex regions in the brain. This non-invasive technique delivers electrical stimulation via a 4-electrode array, potentially enhancing motor function without the side effects associated with traditional medications. Researchers are excited about this device because it could offer a novel and effective way to improve quality of life for those with Parkinson's.

Research has shown that transcranial electrical stimulation (tES) can improve movement in people with Parkinson's disease. Users of similar devices have experienced better walking and reduced slowness in movement, with benefits lasting several months. In this trial, all participants will receive active treatment using the Sphere V3.0 device, safely used by over 250 people without serious side effects. The device sends gentle electrical signals to the brain, potentially reducing tremors and stiffness. Although this research remains in the early stages, initial results suggest this method could help manage movement symptoms in Parkinson's disease.¹²⁴⁶⁷