Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 80Years
All Genders
NCT07182058

Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms

Led by U: The Mind Company · Updated on 2026-01-27

30

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18-80 years with confirmed diagnosis of Parkinson's Disease
  • Hoehn & Yahr stages 1-4
  • Stable medication regimen for 4 or more weeks prior to enrollment
  • Reliable internet access and telehealth capability
  • Ability to provide informed consent
  • Willingness to comply with treatment protocols and follow-up procedures
Not Eligible

You will not qualify if you...

  • Metallic head or neck implants (excluding dental fillings)
  • Pregnancy or nursing status
  • Severe skin conditions at electrode placement sites
  • History of epilepsy or seizures (unless technology specifically indicated)
  • Recent stroke or traumatic brain injury within 6 months
  • Severe cognitive impairment preventing treatment understanding
  • Any neurological disorders contraindicating transcranial electrical stimulation
  • Current participation in other clinical trials
  • Inability to commit to full treatment and follow-up schedule

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

U LLC Headquarters

Cleveland, Ohio, United States, 44124

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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