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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D014202', 'term': 'Tremor'}, {'id': 'D009127', 'term': 'Muscle Rigidity'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D018476', 'term': 'Hypokinesia'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm study where all participants receive active transcranial electrical stimulation treatment with the Sphere V3.0 device. No control or placebo group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in MDS-UPDRS Part III Motor Scores', 'timeFrame': 'Baseline to Week 3 (end of treatment)', 'description': "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."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Tremor', 'Rigidity', 'Dyskinesia', 'Bradykinesia', 'Gait Dysfunction'], 'conditions': ['PARKINSON DISEASE (Disorder)']}, 'descriptionModule': {'briefSummary': "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.\n\nParticipants 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nAll 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", 'detailedDescription': "BACKGROUND AND RATIONALE:\n\nTranscranial 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.\n\nVIRTUAL STUDY DESIGN:\n\nThis 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.\n\nDEVICE SPECIFICATIONS:\n\nThe 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.\n\nCOMPUTER VISION ANALYSIS:\n\nDual 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.\n\nSAFETY MONITORING:\n\nComprehensive 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.\n\nDATA COLLECTION SYSTEMS:\n\nAll 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.\n\nREGULATORY CLASSIFICATION:\n\nThis study operates under Non-Significant Risk (NSR) device classification, providing expedited regulatory pathway while maintaining full IRB oversight and FDA compliance standards."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults 18-80 years with confirmed diagnosis of Parkinson's Disease\n* Hoehn \\& Yahr stages 1-4\n* Stable medication regimen for 4+ weeks prior to enrollment\n* Reliable internet access and telehealth capability\n* Ability to provide informed consent\n* Willingness to comply with treatment protocols and follow-up procedures\n\nExclusion Criteria:\n\n* Metallic head/neck implants (excluding dental fillings)\n* Pregnancy or nursing status\n* Severe skin conditions at electrode placement sites\n* History of epilepsy or seizures (unless technology specifically indicated)\n* Recent stroke or traumatic brain injury (within 6 months)\n* Severe cognitive impairment preventing treatment understanding\n* Any neurological disorders contraindicating transcranial electrical stimulation\n* Current participation in other clinical trials\n* Inability to commit to full treatment and follow-up schedule"}, 'identificationModule': {'nctId': 'NCT07182058', 'briefTitle': "Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms", 'organization': {'class': 'INDUSTRY', 'fullName': 'U: The Mind Company'}, 'officialTitle': "Virtual Remote Assessment of Transcranial Electrical Stimulation for Parkinson's Disease Motor Symptoms", 'orgStudyIdInfo': {'id': 'U-PD-USA-2025-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Treatment Arm', 'description': '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.', 'interventionNames': ['Device: Transcranial Electrical Stimulation Device']}], 'interventions': [{'name': 'Transcranial Electrical Stimulation Device', 'type': 'DEVICE', 'description': 'The Sphere V3.0 is a non-invasive transcranial electrical stimulation device that delivers amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS).', 'armGroupLabels': ['Active Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44124', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Mohammed h Abouelsoud', 'role': 'CONTACT', 'email': 'mo@uthemind.com'}, {'name': 'Hanual Bhandari, MD', 'role': 'CONTACT'}], 'facility': 'U LLC Headquarters', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U: The Mind Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CEO, Neurotechnologist', 'investigatorFullName': 'Mohammed Abouelsoud', 'investigatorAffiliation': 'U: The Mind Company'}}}}