At-home electrical brain stimulation for Parkinson's movement symptoms
Virtual Remote Assessment of Transcranial Electrical Stimulation for Parkinson's Disease Motor Symptoms
This trial tests a wearable, at-home electrical stimulation device called Sphere V3.0 to see if it improves movement problems in adults with Parkinson's disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | U: The Mind Company Industry-sponsored |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07182058 on ClinicalTrials.gov |
What this trial studies
This fully remote Phase 1/2 trial sends the Sphere V3.0 device to participants to use at home for 13 minutes each weekday over three weeks, followed by three weeks of monitoring without treatment. The device delivers amplitude‑modulated transcranial pulsed random noise stimulation (am‑tPRNS) through a four‑electrode array and built‑in safety features. Outcomes include standard Parkinson's rating scales and computer‑vision analysis of standardized and participant‑recorded videos of walking and tremor/hand tasks. The study enrolls 30 adults (ages 18–80) with stable Parkinson's medications and uses telehealth visits for onboarding and assessments.
Who should consider this trial
Good fit: Adults 18–80 with a confirmed Parkinson's diagnosis, Hoehn & Yahr stages 1–4, stable medications for at least four weeks, reliable internet access, and ability to follow telehealth instructions are ideal candidates.
Not a fit: People with metallic head/neck implants, recent stroke or brain injury, a history of epilepsy, severe cognitive impairment, or severe skin problems at electrode sites may not be suitable or receive benefit.
Why it matters
Potential benefit: If successful, the device could reduce tremor, rigidity, slowness, or gait problems and offer a convenient at‑home therapy option.
How similar studies have performed: Prior work with this stimulation approach has enrolled over 250 participants with extensive hours of use and favorable safety reports, but robust, published evidence of clinical benefit remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- U LLC Headquarters — Cleveland, Ohio, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.