Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT02885194
Status:
COMPLETED
Last Update Posted:
2016-10-13
First Post:
2016-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Subthalamic Nucleus Deep Brain Stimulation on Pain in Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D010146', 'term': 'Pain'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D066331', 'term': 'Laser-Evoked Potentials'}], 'ancestors': [{'id': 'D005073', 'term': 'Evoked Potentials, Somatosensory'}, {'id': 'D005071', 'term': 'Evoked Potentials'}, {'id': 'D000071080', 'term': 'Cortical Excitability'}, {'id': 'D055724', 'term': 'Electrophysiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2016-08-26', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modification of habituation in percentage, between tests performed before and after DBS', 'timeFrame': 'After the second laser evoked potential which occurred around 3 months after STN-DBS', 'description': 'The habituation is the change of amplitude between the first and the second response of the double stimulation during the laser evoked potential. We calculated a percentage'}], 'secondaryOutcomes': [{'measure': 'Change in latency of laser evoked potential responses before and after DBS', 'timeFrame': 'After the second laser evoked potential which occurred around 3 months after STN-DBS', 'description': 'latency is calculated in millisecond'}, {'measure': 'Change in amplitude of laser evoked potential responses before and after DBS', 'timeFrame': 'After the second laser evoked potential which occurred around 3 months after STN-DBS', 'description': 'amplitude is calculated in microvolts'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'Pain', 'Deep Brain Stimulation', 'Laser-Evoked Potentials'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Pain is a common symptom of Parkinson's disease (PD) but the physiology remains poorly understood. Recent work suggests that subthalamic nucleus deep brain stimulation (STN-DBS) could make a profit on the pain in PD.\n\nThe investigator would drive a study with a follow up of PD patients before and after STN-DBS. The pain will be clinically explored by targeted questionnaires and electrophysiological through laser evoked potentials.\n\nThe questionnaires are designed to quantify and characterize the pain in these patients. Laser evoked potentials will, through repetitive stimulation, study both the functional status of the afferent nociceptive pathways, their habituation to repetitive nociceptive stimuli, and so better understand any abnormalities of the central processing of nociceptive information."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A patient with idiopathic Parkinson's disease\n* Age between 30 and 70 inclusive.\n* No cognitive decline (MMS greater than or equal to 24)\n* Normal brain MRI\n* Informed consent signed\n* With or without pain sensation\n\nExclusion Criteria:\n\n* Presence of other neurological pathology that could explain the pain.\n* MMS less than 24\n* Pregnant or breastfeeding women"}, 'identificationModule': {'nctId': 'NCT02885194', 'briefTitle': 'Impact of Subthalamic Nucleus Deep Brain Stimulation on Pain in Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Impact of Subthalamic Nucleus Deep Brain Stimulation on Pain in Parkinson Disease : Clinical and Neurophysiological Study', 'orgStudyIdInfo': {'id': '2014.866'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients who underwent Deep Brain Stimulation (DBS)', 'description': 'Patients who underwent Subthalamic Nucleus (STN)-DBS at Lyon', 'interventionNames': ['Other: Laser-Evoked potential']}], 'interventions': [{'name': 'Laser-Evoked potential', 'type': 'OTHER', 'description': 'Laser-Evoked potential can document lesions of spinothalamic tract and lateral brainstem and of thalamo-cortical projections conducting nociceptive signals. The rapid heating of skin by infrared laser pulses stimulate small fibers sensory pathways. The main cortical laser evoked potential is a complex of components N2-P2. Evaluation of the registered potentials includes shape, latency and amplitude.', 'armGroupLabels': ['Patients who underwent Deep Brain Stimulation (DBS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Service de Neurologie C, Hôpital Neurologique, HCL', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Stéphane THOBOIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}