PARKINSON DISEASE (Disorder)Phase 1/2NCT07182058
Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms
A Phase 1/2 study testing Transcranial Electrical Stimulation Device in people with PARKINSON DISEASE (Disorder), run by U: The Mind Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Transcranial Electrical Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Any neurological disorders contraindicating transcranial electrical stimulation
- Current participation in other clinical trials
- Inability to commit to full treatment and follow-up schedule
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
U LLC Headquarters
Cleveland, Ohio, 44124
Mohammed h Abouelsoud, mo@uthemind.com
Hanual Bhandari, MD
About this study
Official title: Virtual Remote Assessment of Transcranial Electrical Stimulation 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 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.
Read more
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
Read the detailed description
BACKGROUND AND RATIONALE:
Transcranial electrical stimulation (tES) represents a promising non-invasive approach for treating Parkinson's disease motor symptoms. The Sphere V3.0 device utilizes amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS) with randomized timing parameters to target motor cortex regions. Previous clinical experience with this technology includes over 250 participants across multiple studies with over 30,000 hours of treatment data and no adverse events recorded.
VIRTUAL STUDY DESIGN:
This fully remote study leverages HIPAA-compliant telehealth platforms to conduct all assessments and monitoring virtually. Participants receive the device via mail with comprehensive training materials and video tutorials. Virtual onboarding includes supervised device setup and electrode placement training via video call.
DEVICE SPECIFICATIONS:
The Sphere V3.0 employs a 4-electrode array configuration with 3D-printed dry electrodes and dual-channel programmability. Stimulation parameters include pulse duration of 450-650ms (randomly varied), inter-pulse intervals of 45-65ms, phase durations of 4.5-5.5 seconds, and current intensity up to 4mA maximum. Safety features include current limiting circuitry, automatic shutoff if skin contact is compromised, and biocompatible electrode materials.
COMPUTER VISION ANALYSIS:
Dual video protocols collect standardized movement assessments for objective analysis. Protocol A focuses on computer vision analysis with specific camera positioning for tremor (top-down view with white tablecloth) and gait assessment (perpendicular and end-on camera angles). Protocol B provides standard clinical videos for potential future MDS-UPDRS scoring. All videos are collected at consistent times, preferably before 9 AM.
SAFETY MONITORING:
Comprehensive remote safety monitoring includes weekly digital diary submissions, 24/7 emergency hotline support, and predefined escalation pathways. Level 1 events (mild headache, slight skin irritation) are documented in daily diaries. Level 2 events (persistent symptoms) require immediate hotline contact. Level 3 events (severe symptoms) mandate device cessation and emergency medical evaluation.
DATA COLLECTION SYSTEMS:
All data is collected through encrypted, HIPAA-compliant electronic data capture systems with secure cloud-based storage. Device usage metrics are transmitted in real-time to study coordinators. Video uploads utilize automated processing for standardized analysis.
REGULATORY CLASSIFICATION:
This study operates under Non-Significant Risk (NSR) device classification, providing expedited regulatory pathway while maintaining full IRB oversight and FDA compliance standards.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Transcranial Electrical Stimulation Device
- Keywords
- Tremor, Rigidity, Dyskinesia, Bradykinesia, Gait Dysfunction
- Medical subject headings
- Parkinson Disease, Tremor, Muscle Rigidity, Dyskinesias, Hypokinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Electrical Stimulation DeviceDevice
The Sphere V3.0 is a non-invasive transcranial electrical stimulation device that delivers amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial Electrical Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 3 (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Jan 2026
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm study where all participants receive active transcranial electrical stimulation treatment with the Sphere V3.0 device. No control or placebo group.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U: The Mind Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Mohammed Abouelsoud, U: The Mind Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182058
- Sponsor's protocol ID
- U-PD-USA-2025-001
- Status last verified
- Jan 2026
- First submitted
- 16 Sep 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Remote Assessment of Transcranial Electrical Stimulation for Parkinson's Disease Motor Symptoms
- ClinicalTrials.gov ID
- NCT07182058
- Acronym / sponsor ID
- U-PD-USA-2025-001
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Tremor, Rigidity, Dyskinesia, Bradykinesia, Gait Dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- U: The Mind CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
BACKGROUND AND RATIONALE:
Transcranial electrical stimulation (tES) represents a promising non-invasive approach for treating Parkinson's disease motor symptoms. The Sphere V3.0 device utilizes amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS) with randomized timing parameters to target motor cortex regions. Previous clinical experience with this technology includes over 250 participants across multiple studies with over 30,000 hours of treatment data and no adverse events recorded.
VIRTUAL STUDY DESIGN:
This fully remote study leverages HIPAA-compliant telehealth platforms to conduct all assessments and monitoring virtually. Participants receive the device via mail with comprehensive training materials and video tutorials. Virtual onboarding includes supervised device setup and electrode placement training via video call.
DEVICE SPECIFICATIONS:
The Sphere V3.0 employs a 4-electrode array configuration with 3D-printed dry electrodes and dual-channel programmability. Stimulation parameters include pulse duration of 450-650ms (randomly varied), inter-pulse intervals of 45-65ms, phase durations of 4.5-5.5 seconds, and current intensity up to 4mA maximum. Safety features include current limiting circuitry, automatic shutoff if skin contact is compromised, and biocompatible electrode materials.
COMPUTER VISION ANALYSIS:
Dual video protocols collect standardized movement assessments for objective analysis. Protocol A focuses on computer vision analysis with specific camera positioning for tremor (top-down view with white tablecloth) and gait assessment (perpendicular and end-on camera angles). Protocol B provides standard clinical videos for potential future MDS-UPDRS scoring. All videos are collected at consistent times, preferably before 9 AM.
SAFETY MONITORING:
Comprehensive remote safety monitoring includes weekly digital diary submissions, 24/7 emergency hotline support, and predefined escalation pathways. Level 1 events (mild headache, slight skin irritation) are documented in daily diaries. Level 2 events (persistent symptoms) require immediate hotline contact. Level 3 events (severe symptoms) mandate device cessation and emergency medical evaluation.
DATA COLLECTION SYSTEMS:
All data is collected through encrypted, HIPAA-compliant electronic data capture systems with secure cloud-based storage. Device usage metrics are transmitted in real-time to study coordinators. Video uploads utilize automated processing for standardized analysis.
REGULATORY CLASSIFICATION:
This study operates under Non-Significant Risk (NSR) device classification, providing expedited regulatory pathway while maintaining full IRB oversight and FDA compliance standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm study where all participants receive active transcranial electrical stimulation treatment with the Sphere V3.0 device. No control or placebo group.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Arm | Experimental | Device: Transcranial Electrical Stimulation DeviceAll 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Electrical Stimulation DeviceThe Sphere V3.0 is a non-invasive transcranial electrical stimulation device that delivers amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS). | Device | Active Treatment Arm |
Primary outcome
Change in MDS-UPDRS Part III Motor Scores
Time frame: Baseline to Week 3 (end of treatment)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcranial Electrical Stimulation Device in people with PARKINSON DISEASE (Disorder), run by U: The Mind Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MDS-UPDRS Part III Motor Scores (time frame: Baseline to Week 3 (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.