Recruiting
Phase 1
Phase 2

Sphere V3.0

Sponsor:

U: The Mind Company

Code:

NCT07182058

Conditions

PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial Electrical Stimulation Device

Study Details

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)

Study ID

NCT07182058

Start date

Jan 1, 2026

Status verified date

Jan, 2026

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Treatment Arm

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.

Interventions

Transcranial Electrical Stimulation Device

The Sphere V3.0 is a non-invasive transcranial electrical stimulation device that delivers amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS).

Primary outcome measure

  • Change in MDS-UPDRS Part III Motor Scores [ Time Frame: Baseline to Week 3 (end of treatment) ]

Central Contacts and Locations

Locations

U LLC Headquarters

Recruiting

Cleveland, Ohio, United States, 44124

Contacts

Mohammed h Abouelsoud

mo@uthemind.com

More Information

Sponsor

U: The Mind Company

Last update posted

Jan 27, 2026

Last verified

Jan, 2026

Keywords

  • Tremor
  • Rigidity
  • Dyskinesia
  • Bradykinesia
  • Gait Dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by U: The Mind Company on 2026-01-27.