Movement Disorders Clinical Trials

Find Movement Disorders Clinical Trials Near You

Virtual Remote Assessment of Transcranial Electrical Stimulation for Parkinson's Disease Motor Symptoms

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
U LLC Headquarters
RECRUITING
Cleveland
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 30
Treatments
Experimental: Active Treatment Arm
All participants receive active transcranial electrical stimulation treatment using the Sphere V3.0 device. Treatment consists of 13-minute daily sessions Monday through Friday for 3 weeks (15 total sessions), followed by 3 weeks of follow-up monitoring without device use. The device delivers amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS) with current intensity up to 4mA through a 4-electrode array placed on the scalp targeting motor cortex regions.
Sponsors
Leads: U: The Mind Company

This content was sourced from clinicaltrials.gov

Similar Clinical Trials