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Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms

RecruitingPhase 1, Phase 2Ages 18 Years - 80 YearsAllU: The Mind Company
NCT07182058 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 medicat

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults 18-80 years with confirmed diagnosis of Parkinson's Disease * Hoehn \& Yahr stages 1-4 * Stable medication regimen for 4+ 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 Exclusion Criteria: * Metallic head/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
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What it tests

  • Transcranial Electrical Stimulation Device
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Where

1 site
U LLC Headquarters
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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