Virtual Remote Assessment of Transcranial Electrical Stimulation for Parkinson's Disease Motor Symptoms
U: The Mind Company
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
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 amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS) with randomized timing parameters to target motor cortex regions. Previous clinical experience with this technology includes over 250 participants across multiple studies with over 30,000 hours of treatment data and no adverse events recorded. VIRTUAL STUDY DESIGN: This fully remote study leverages HIPAA-compliant telehealth…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceTranscranial 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).
Location
- U LLC HeadquartersCleveland, Ohio