Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-29 @ 10:29 AM
Study NCT ID:
NCT06533969
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2024-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Neural Signals for the Control of Assistive Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004569', 'term': 'Electroencephalography'}], 'ancestors': [{'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hand Motor Function', 'timeFrame': 'Baseline, up to 2 months post-implant', 'description': 'Toronto Rehabilitation Institute Hand Function Test (TRI-HFT): Measured on a scale from 0-133 to assess upper extremity manipulation and grip force at time points before and after implant.\n\nHigher scores indicate better hand motor function.'}, {'measure': 'Change in Hand Motor Evoked Potential (MEP)', 'timeFrame': 'Baseline, up to 2 months post-implant', 'description': 'Change in Motor Evoked Potential (MEP): MEP evaluates corticospinal excitability (strength of the connections between the brain and the muscles). The excitability is measured as a peak-to-peak amplitude in millivolts (mV).'}], 'secondaryOutcomes': [{'measure': 'Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)', 'timeFrame': 'Baseline, up to 2 months post-implant', 'description': 'Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP): Standardized test to be measured on a scale from 0-116 through the combination of five subset scores to assess grasping ability at time points before and after implant. A composite score will be obtained for strength, muscle force and tasks.\n\nHigher scores indicate better hand motor function.'}, {'measure': 'Change in Muscle Coordination Measured by Electromyography (EMG)', 'timeFrame': 'Baseline, up to 2 months post-implant', 'description': 'Functional tasks: Assessments to measure reaching ability and obtain muscle coordination via EMG (millivolts).'}, {'measure': 'Change in Movement Kinematics', 'timeFrame': 'Baseline, up to 2 months post-implant', 'description': 'Kinematics data (motion capture, measured in centimeters) at time points before and after implant.'}, {'measure': 'Change in Muscle Strength', 'timeFrame': 'Baseline, up to 2 months post-implant', 'description': 'Muscle force testing: Assessment of changes in muscle strength from measured in Newtons at time points before and after implant.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline, up to 2 months post-implant', 'description': 'Quality of Life using the International Spinal Cord Injury - Quality of Life (ISCI-QOL): ISCI-QOL consists of three single items on satisfaction with life as a whole, physical health, and psychological health using a 0-10 scale where 0=complete dissatisfaction; 10=complete satisfaction.\n\nA composite score will be obtained for this measure.'}, {'measure': 'Change in Independence Measured by Spinal Cord Independence Measure (SCIM III)', 'timeFrame': 'Baseline, up to 2 months post-implant', 'description': 'Independence as measured by Spinal Cord Independence Measure (SCIM III): SCIM III assesses performance in activities of daily living Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence.'}, {'measure': 'Change in Satisfaction of Life', 'timeFrame': 'Baseline, up to 2 months post-implant', 'description': 'Medical Outcomes Study Short Form 36 (SF-36): Patient-reported outcome measurement for health-related quality of life and activities of daily living scored on a scale of 0 (negative health) to 100 (positive health).'}, {'measure': 'Change in Pain Levels', 'timeFrame': 'Baseline, up to 2 months post-implant', 'description': 'Brief Pain Inventory (BPI): A questionnaire for pain will be assessed on a scale of 0 ("no pain") to 10 ("worst imaginable pain") at different points before and after the implant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain Computer Interface', 'Epidural Spinal Cord Stimulation'], 'conditions': ['Spinal Cord Injury (SCI), Initial Encounter']}, 'descriptionModule': {'briefSummary': 'The study will investigate the use of motor intention-based cortical signals to trigger epidural spinal cord stimulation (ESCS) with individuals with SCI. Motor intention of UL tasks will be decoded using brain-computer interface (BCI) system based on cortical signals recorded using an Electroencephalographic (EEG) system or using their intracranially implanted devices Electrocorticographic (ECoG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age 18 and older\n* Able to sign informed consent\n* Not participating in other studies that limit participation\n* Chronic (\\>6 month) traumatic Spinal Cord Injury (SCI) (C4-T1 neurological injury with American Spinal Injury Association Impairment Scale (AIS A-D) with some residual function.\n\nExclusion Criteria:\n\n* Patients that are pregnant\n* Patients under the age of 18\n* Patients unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06533969', 'briefTitle': 'Assessment of Neural Signals for the Control of Assistive Devices', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Assessment of Neural Signals for the Control of Assistive Devices', 'orgStudyIdInfo': {'id': '20190536'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS)', 'description': 'Participants in this group will receive a onetime surgery to have the leads implanted temporarily for ESCS which will be triggered through the BCI system. The BCI-ESCS arms will include Upper limb (UL) therapist-guided training, with triggered through a BCI system during task practice. The BCI system will decode motor intention of Upper limb (UL) tasks from cortical signals recorded using EEG system or using their intracranially implanted devices (e.g., ECoG). Participants will perform UL daily activities (e.g., grasping, reaching) tailored to participants deficits. The therapist will facilitate task practice and progress therapy within and between session.\n\nSubjects will be involved in the intervention for up to 2 months.', 'interventionNames': ['Procedure: Epidural Spinal Cord Stimulation', 'Device: Electrocorticographic', 'Device: Electroencephalographic']}], 'interventions': [{'name': 'Epidural Spinal Cord Stimulation', 'type': 'PROCEDURE', 'otherNames': ['ESCS'], 'description': 'This will be a one time surgery lasting no more than 2 hours where ESCS electrodes will be connected to an external stimulator approved for human research. Stimulation intensity and parameters will be configured before each session for optimal upper extremity motor function.\n\nThe ESCS approach will include surgical implantation of temporarily placed leads in the cervical epidural space and connection cables tunneled percutaneously through the skin for \\<30 days', 'armGroupLabels': ['Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS)']}, {'name': 'Electrocorticographic', 'type': 'DEVICE', 'otherNames': ['ECoG'], 'description': 'Neural activity during upper and/or lower extremity tasks will be recorded to characterize the changes that occur in the signals before, during, and after task performance. Observed characteristics of neural signals that are related to the initiation, continuation, or termination of movement will be used to derive control signals that can trigger or enable assistive devices.', 'armGroupLabels': ['Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS)']}, {'name': 'Electroencephalographic', 'type': 'DEVICE', 'otherNames': ['EEG'], 'description': 'Neural activity during upper and/or lower extremity tasks will be recorded to characterize the changes that occur in the signals before, during, and after task performance. Observed characteristics of neural signals that are related to the initiation, continuation, or termination of movement will be used to derive control signals that can trigger or enable assistive devices.', 'armGroupLabels': ['Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Letitia Fisher', 'role': 'CONTACT', 'email': 'lfisher@miami.edu', 'phone': '305-243-3056'}, {'name': 'Matija Milosevic, PhD', 'role': 'CONTACT', 'email': 'mxm194475@miami.edu', 'phone': '3052433572'}, {'name': 'Jonathan R Jagid, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joacir Graciolli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Abhishek Prasad, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Matija Milosevic, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Lynn Rehabilitation Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Letitia Fisher, BLA', 'role': 'CONTACT', 'email': 'lfisher@miami.edu', 'phone': '305-243-3056'}, {'name': 'Matija Milosevic, Co-I, PhD', 'role': 'CONTACT', 'email': 'mmilosevic@med.miami.edu', 'phone': '305-243-3572'}, {'name': 'Jonathan R. Jagid, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joacir Graciolli., MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mitja Milosevic, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Miami Project to Cure Paralysis', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Letitia Fisher', 'role': 'CONTACT', 'email': 'lfisher@miami.edu', 'phone': '305-243-3056'}, {'name': 'Matija Milosevic, PhD', 'role': 'CONTACT', 'email': 'mxm194475@miami.edu', 'phone': '305-243-3572'}], 'overallOfficials': [{'name': 'Jonathan R Jagid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurological Surgery', 'investigatorFullName': 'Jonathan Jagid', 'investigatorAffiliation': 'University of Miami'}}}}