RecruitingPhase 1Phase 2NCT07182058

Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms

Virtual Remote Assessment of Transcranial Electrical Stimulation for Parkinson's Disease Motor Symptoms


Sponsor

U: The Mind Company

Enrollment

30 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study tests a new, non-invasive brain stimulation device called Sphere V3.0 to help improve movement problems in people with Parkinson's disease. The device delivers gentle electrical signals to the scalp using small electrodes placed on the head. Participants will use the device at home for 13 minutes each weekday (Monday through Friday) for 3 weeks, then be monitored for another 3 weeks without treatment. The entire study lasts 6 weeks and is conducted virtually through video calls and online assessments. The investigators will measure changes in Parkinson's symptoms using standard rating scales and video recordings of movement tasks like walking and hand tremor tests. Participants will also record videos of their movements at home using their smartphone or computer. The study includes 30 adults aged 18-80 who have been diagnosed with Parkinson's disease and have stable medication for at least 4 weeks. Participants must have reliable internet access and be able to follow the treatment schedule. The main goal is to see if this brain stimulation treatment can reduce motor symptoms like tremor, stiffness, and slowness of movement. The investigators will also check if any improvements last after treatment ends and monitor for any side effects. All participants receive the active device treatment - there is no placebo group. The device has been tested in over 250 people in previous studies with no serious adverse events reported


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a non-invasive brain stimulation device delivered via telehealth (at home) for people with Parkinson's disease. The device uses mild electrical currents applied through the scalp to try to improve movement-related symptoms, and the treatment is monitored remotely. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with Parkinson's disease - Your Parkinson's is in stages 1-4 on the Hoehn & Yahr scale (mild to moderately severe) - Your medications have been stable for at least 4 weeks - You have reliable internet access and can participate in telehealth sessions **You may NOT be eligible if...** - You have metal implants in your head or neck (except dental fillings) - You are pregnant or nursing - You have a history of epilepsy or seizures - You have had a stroke or serious brain injury in the past 6 months - You have severe cognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscranial Electrical Stimulation Device

The Sphere V3.0 is a non-invasive transcranial electrical stimulation device that delivers amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS).


Locations(1)

U LLC Headquarters

Cleveland, Ohio, United States

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NCT07182058


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