Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
U: The Mind Company
Study ID
NCT07182058
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Electrical Stimulation Device — DEVICE
    The Sphere V3.0 is a non-invasive transcranial electrical stimulation device that delivers amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS).

Study Details

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

Key Dates

Start date
Jan 1, 2026
Status verified
Jan 2026
Primary completion
Mar 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in MDS-UPDRS Part III Motor Scores [ Time Frame: Baseline to Week 3 (end of treatment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
U LLC HeadquartersClevelandOhio44124
Mohammed h Abouelsoud
[email protected]
Hanual Bhandari, MD

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By research site
U LLC Headquarters· Cleveland, OH

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