NCT07182058 Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms
| NCT ID | NCT07182058 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | U: The Mind Company |
| Condition | PARKINSON DISEASE (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-01-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Frequently Asked Questions
Who can join the NCT07182058 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying PARKINSON DISEASE (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07182058 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07182058 currently recruiting?
Yes, NCT07182058 is actively recruiting participants. Visit ClinicalTrials.gov or contact U: The Mind Company to inquire about joining.
Where is the NCT07182058 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07182058 clinical trial?
NCT07182058 is sponsored by U: The Mind Company. The trial plans to enroll 30 participants.
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