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NCT07182058 · ClinicalTrials.gov registry record · Phase 1
Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms
A Phase 1 study of PARKINSON DISEASE (Disorder), sponsored by U: The Mind Company.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT07182058: Recruiting Phase 1 study of PARKINSON DISEASE (Disorder), sponsored by U: The Mind Company.
NCT07182058 is a Phase 1 study of PARKINSON DISEASE (Disorder) that is actively recruiting participants, run by U: The Mind Company. The registered enrollment target is 30 participants, below the 39-participant average among 5 other PARKINSON DISEASE (Disorder) trials with a reported enrollment target (23% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07182058, a Phase 1 study of PARKINSON DISEASE (Disorder), is actively recruiting participants, sponsored by U: The Mind Company.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Transcranial Electrical Stimulation Device
Study Locations (1)
Ohio
- U LLC Headquarters - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-01-01 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 1 |
What NCT07182058 shows while recruiting
NCT07182058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 39-participant average among 5 other PARKINSON DISEASE (Disorder) trials with a reported enrollment target (23% lower).
The record links to 1 condition, with PARKINSON DISEASE (Disorder) appearing as the primary indexed condition, and to 1 intervention - of which Transcranial Electrical Stimulation Device is the first listed.
NCT07182058 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT07182058 about?
NCT07182058 is a clinical study titled "Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms". 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 1...
What is the current status of trial NCT07182058?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-01-01. Estimated completion is 2026-04-01.
What conditions does trial NCT07182058 study?
This clinical trial studies the following conditions: PARKINSON DISEASE (Disorder).
What interventions are being tested in trial NCT07182058?
The interventions under investigation include: Transcranial Electrical Stimulation Device (DEVICE).
Who is sponsoring clinical trial NCT07182058?
This trial is sponsored by U: The Mind Company, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07182058 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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