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RECRUITING
NCT07182058
PHASE1/PHASE2

Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms

Sponsor: U: The Mind Company

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-01-01

Completion Date

2026-04-01

Last Updated

2026-01-27

Healthy Volunteers

No

Interventions

DEVICE

Transcranial 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