Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-28 @ 2:38 PM
Study NCT ID:
NCT01682668
Status:
RECRUITING
Last Update Posted:
2024-11-27
First Post:
2012-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subthalamic Nucleus, Akinesia and Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2012-07-19', 'studyFirstSubmitQcDate': '2012-09-07', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'BOLD signal during fMRI', 'timeFrame': '1 month before surgery', 'description': 'Changes in the BOLD signal during fMRI with virtual imagery of movement'}, {'measure': 'real-life assessment', 'timeFrame': '1 month after surgery', 'description': 'recording using the percept device'}], 'primaryOutcomes': [{'measure': 'Firing rate of the subthalamic neurons', 'timeFrame': 'During surgery for bilateral STN stimulation', 'description': 'Changes in the neuronal activity of the STN before, during and after the execution of an arm movement'}], 'secondaryOutcomes': [{'measure': 'Evoked related potentials of the STN', 'timeFrame': '3-5 days after surgery for bilateral STN stimulation', 'description': 'Local-field potentials recordings with DBS electrodes when performing the execution of an arm movement or gait initiation'}, {'measure': 'Biomechanical parameters of gait initiation', 'timeFrame': '6 months', 'description': 'Gait initiation parameters by using a forceplate and EMG recordings'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["parkinson's disease", 'subthalamic nucleus', 'akinesia', 'gait initiation', 'neuronal activity', 'before STN stimulation', 'with STN stimulation', 'functional MRI'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "This program aims to understand the role of the subthalamic nucleus in the control of the movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction contributes to akinesia and how the STN stimulation improves motor signs in PD patients ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria for patients who will be operated\n\n1. Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank)\n2. Age between 18 and 70;\n3. Motor complications in the form of fluctuations in motor state or dyskinesias induced by dopaminergic therapy, despite medical treatment optimum;\n4. Other medical conditions that are stable or do not interfere with the procedure proposed;\n5. Excellent responsiveness to levodopa (UPDRS motor score improvement greater than 50% in the acute levodopa test)\n6. Brain MRI without abnormality\n7. Normality of biological examinations\n8. Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)\n9. Patient with social health insurance\n\nCriteria for non-inclusion of Parkinsonian patients who will be operated\n\n1. Contraindication to examinations necessary for inclusion\n2. Evolutionary psychiatric pathology;\n3. Dementia(MMS\\<24/30);\n4. Patients with a medical condition that makes surgery dangerous neuro-surgical;\n5. Bleeding-promoting diseases and laboratory test abnormalities clotting;\n6. Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia).\n7. Taking drugs interfering with coagulation for 1 month before intervention.\n8. Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty\n\nSelection criteria for non-operated patients\n\n1. Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank);\n2. Age between 18 and 70;\n3. Other medical conditions that are stable or do not interfere with the proposed protocol;\n4. Presence of axial signs (gait and/or balance disorders) no improved by antiparkinsonian treatment\n5. Brain MRI without notable abnormality\n6. Normality of biological examinations\n7. Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)\n8. Patient with social health insurance\n\nCriteria for non-inclusion of non-operated patients\n\n1. Contraindication to examinations necessary for inclusion\n2. Progressive psychiatric pathology;\n3. Dementia (MMS\\<24/30);\n4. Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia).\n5. Persons under guardianship, curatorship or any other administrative or judicial measuredeprivation of rights and liberty\n\nInclusion criteria for group 3 patients (already operated)\n\n1. Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank);\n2. Bilateral deep brain stimulation of the subthalamic nucleus for more than 1 year\n3. Age between 18 and 70;\n4. Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)\n5. Patient with social health insurance\n\nCriteria for non-inclusion of Parkinsonian patients (already operated)\n\n1. Contraindication to examinations necessary for inclusion\n2. Evolutionary psychiatric pathology;\n3. Dementia(MMS\\<24/30);\n4. Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty\n\nInclusion criteria for healthy subjects\n\n1. Age between 18 and 70 years old\n2. Normal neurological examination\n3. Person who voluntarily and informedly agreed to participate in the study (signature of a written consent)\n4. Patient with social health insurance\n\nCriteria for non-inclusion of healthy subjects\n\n1. Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and freedom\n2. Existence of neurological, orthopedic or psychiatric history\n3. Existence of contraindications to MRI (cardiac or neural pacemaker, ferromagnetic surgical clips, implants and metallic objects, foreign bodies intraocular, pregnancy, claustrophobia)."}, 'identificationModule': {'nctId': 'NCT01682668', 'acronym': 'GB-MOV', 'briefTitle': "Subthalamic Nucleus, Akinesia and Parkinson's Disease", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': "Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.", 'orgStudyIdInfo': {'id': 'C11-40'}, 'secondaryIdInfos': [{'id': '2012-A00225-38', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Frequency of subthalamic stimulation', 'description': 'Comparison between healthy controls and PD patients (non-operable patients or who will be operated or already operated)', 'interventionNames': ['Procedure: Bilateral subthalamic stimulation']}], 'interventions': [{'name': 'Bilateral subthalamic stimulation', 'type': 'PROCEDURE', 'armGroupLabels': ['Frequency of subthalamic stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Laure WELTER, PH', 'role': 'CONTACT', 'email': 'marielaure.welter@icm-institute.org', 'phone': '0142162461'}], 'facility': 'CIC-GHPS', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Laure Welter, MD, PhD', 'role': 'CONTACT', 'email': 'marie-laure.welter@psl.aphp.fr'}], 'facility': 'Groupe Hospitalier Pitie-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Marie-Laure Welter, MD, PhD', 'role': 'CONTACT', 'email': 'marielaure.welter@icm-institute.org'}, {'name': 'Carine Karachi, MD, PhD', 'role': 'CONTACT', 'email': 'carine.karachi@gmail.com'}], 'overallOfficials': [{'name': 'Marie-Laure Welter, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GHPS, APHP, Paris, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}