Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms
Recruiting · NCT07182058 · Interventional (participants receive a specific treatment) · Lead sponsor: U: The Mind Company
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
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
Where it is running
1 location listed across 1 US state.
- U LLC Headquarters - Cleveland, Ohio, United States