Recruiting

Transcranial Electrical Stimulation for Parkinson's Disease Motor Symptoms

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What is being tested

Transcranial Electrical Stimulation Device

Device
Who is being recruted

Synucleinopathies+17

+ Basal Ganglia Diseases

+ Brain Diseases

From 18 to 80 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorU: The Mind Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2026

Actual date on which the first participant was enrolled.

The study is focused on using a new technology called transcranial electrical stimulation (tES) to help manage movement symptoms in people with Parkinson's disease. This technology, delivered through a device known as Sphere V3.0, aims to non-invasively stimulate parts of the brain that control movement. It is significant as it offers a potential treatment without the need for surgery or medication, which may provide a safer alternative for managing symptoms. The study targets individuals with Parkinson's and uses a fully remote setup, allowing participants to receive and use the device at home. Participants are sent the Sphere V3.0 device through the mail, along with instructions and video tutorials. They are trained through video calls to correctly set up and use the device, which involves placing electrodes on the head to deliver the stimulation. The study measures the effectiveness of the treatment by analyzing participants' movements through video assessments. These videos are taken at specific times and angles to ensure consistency. Safety is a priority, with 24/7 emergency support, regular digital diary entries for reporting minor issues, and a structured response plan for more serious events. All data is securely collected and stored, ensuring participants' privacy throughout the study.

Official TitleVirtual Remote Assessment of Transcranial Electrical Stimulation for Parkinson's Disease Motor Symptoms
NCT07182058
Principal SponsorU: The Mind Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersMuscle HypertoniaMuscle RigidityMuscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeurologic ManifestationsParkinson DiseaseSigns and SymptomsPathological Conditions, Signs and SymptomsTremorHypokinesiaNeurodegenerative DiseasesParkinsonian DisordersDyskinesiasNeuromuscular Manifestations

Criteria

6 inclusion criteria required to participate
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

Show More Criteria

9 exclusion criteria prevent from participating
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)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

U LLC Headquarters

Cleveland, United StatesOpen U LLC Headquarters in Google Maps
Recruiting
One Study Center