Status:
NOT_YET_RECRUITING
Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms
Lead Sponsor:
U: The Mind Company
Conditions:
PARKINSON DISEASE (Disorder)
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
BACKGROUND AND RATIONALE: Transcranial electrical stimulation (tES) represents a promising non-invasive approach for treating Parkinson's disease motor symptoms. The Sphere V3.0 device utilizes ampli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07182058
Start Date
September 1 2025
End Date
March 1 2026
Last Update
September 24 2025
Active Locations (1)
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1
U LLC Headquarters
Cleveland, Ohio, United States, 44124