Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms

NCT07182058 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: U-PD-USA-2025-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Tremor; Rigidity; Dyskinesia; Bradykinesia; Gait Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in MDS-UPDRS Part III Motor Scores

  Change from baseline to end of treatment in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III motor examination scores. The MDS-UPDRS Part III assesses motor signs of Parkinson's disease including tremor, rigidity, bradykinesia, and postural instability. Scores range from 0-132 with higher scores indicating worse motor function. All assessments conducted by qualified medical personnel including physicians, certified research coordinators, or trained clinical research assistants under physician supervision.

  Baseline to Week 3 (end of treatment)

Study Arms (1)

Active Treatment Arm

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.

Device: Transcranial Electrical Stimulation Device

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).

Active Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• U: The Mind Company: lead

Study Sites (1)

U LLC Headquarters

Cleveland, Ohio, 44124, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Tremor; Muscle Rigidity; Dyskinesias; Hypokinesia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO, Neurotechnologist

Model Details: Single-arm study where all participants receive active transcranial electrical stimulation treatment with the Sphere V3.0 device. No control or placebo group.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 19, 2025
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (1)