Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT07182058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms
Sponsor:
U: The Mind Company
Organization:
Study Overview
Official Title:
Virtual Remote Assessment of Transcranial Electrical Stimulation for Parkinson's Disease Motor Symptoms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: