tES Device for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
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.
What prior data suggests that the Sphere V3.0 device is safe for people with Parkinson's disease?
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
Why do researchers think this study treatment might be promising for Parkinson's disease?
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.
What evidence suggests that the Sphere V3.0 device is effective for improving movement problems in Parkinson's disease?
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
Are You a Good Fit for This Trial?
Adults aged 18-80 with Parkinson's disease who have stable medication for at least a month can join this study. They need reliable internet and the ability to use the device at home following a set schedule. The trial is not suitable for those who don't meet these requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the Sphere V3.0 device at home for 13 minutes each weekday for 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment without device use
What Are the Treatments Tested in This Trial?
Interventions
- Sphere V3.0
Trial Overview
The Sphere V3.0, a non-invasive brain stimulation device, is being tested to see if it improves movement problems in Parkinson's patients over six weeks of treatment and monitoring, all done virtually.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants receive active transcranial electrical stimulation treatment using the Sphere V3.0 device. Treatment consists of 13-minute daily sessions Monday through Friday for 3 weeks (15 total sessions), followed by 3 weeks of follow-up monitoring without device use. The device delivers amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS) with current intensity up to 4mA through a 4-electrode array placed on the scalp targeting motor cortex regions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
U: The Mind Company
Lead Sponsor
Citations
Virtual tES Device Treatment for Parkinson's Disease Motor ...
This study tests a new, non-invasive brain stimulation device called Sphere V3.0 to help improve movement problems in people with Parkinson's ...
expert recommendation based on a Delphi consensus study
Even slight variations of stimulation parameters can lead to notable changes of the stimulation effects, including reversal of its intended ...
Virtual tES Device Treatment for Parkinson's Disease Motor ...
This study tests a new, non-invasive brain stimulation device called Sphere V3.0 to help improve movement problems in people with Parkinson's ...
Transcranial Direct Current Stimulation for the Treatment ...
TDCS improved gait by some measures for a short time and improved bradykinesia in both the on- and off-states for longer than 3 months.
Ultrasound + Electrical Stimulation for Parkinson's Disease
Low-intensity transcranial focused ultrasound (TUS) significantly increased motor cortex excitability in Parkinson's disease patients, as evidenced by higher ...
Transcranial electrical stimulation (TES) in human motor ...
TACS has been successfully used in the modulation of human perception and motor coordination, as well as in the clinical treatment of psychiatric disorders such ...
An educational program for remote training and supervision of ...
The Home based transcranial electrical stimulation training program was developed aiming to fulfill the IFCN recommendations on training in ...
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