Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-02 @ 11:07 AM
Study NCT ID:
NCT01081457
Status:
COMPLETED
Last Update Posted:
2012-02-07
First Post:
2010-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-06', 'studyFirstSubmitDate': '2010-03-04', 'studyFirstSubmitQcDate': '2010-03-04', 'lastUpdatePostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anal pressure', 'timeFrame': '2 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'deep brain stimulation', 'GI motility'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '26053217', 'type': 'DERIVED', 'citation': 'Derrey S, Chastan N, Maltete D, Verin E, Dechelotte P, Lefaucheur R, Proust F, Freger P, Leroi AM, Weber J, Gourcerol G. Impact of deep brain stimulation on pharyngo-esophageal motility: a randomized cross-over study. Neurogastroenterol Motil. 2015 Sep;27(9):1214-22. doi: 10.1111/nmo.12607. Epub 2015 Jun 5.'}]}, 'descriptionModule': {'briefSummary': "Parkinson's disease is characterized by extra-pyramidal symptoms as well as digestive involvement with gastrointestinal motility (GI) impairment. Deep brain stimulation has been recently developed as a successful treatment for extrapyramidal symptoms. In addition, preliminary reports suggest that this therapy might be successful to relieve GI symptoms as well. The aim of this study is therefore to assess the effect of deep brain stimulation on GI voluntary as well as involuntary motility."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patient over 18 yo\n* patient with Parkinson's disease implanted for deep brain stimulation\n* patient responders to deep brain stimulation (UPDRS improved by at least 40%)\n* patient covered by the french health care system\n* patient not taking anti-parkinsonian medication the day before evaluation\n* French speaking\n\nExclusion Criteria:\n\n* patient below 18 yo\n* pregnancy\n* Severe psychiatric or cognitive disorders\n* diabetes mellitus\n* morbid obesity\n* compulsive eating disorders\n* diffuse GI motility impairment (except Parkinson's disease)\n* other evolutive neurologic disorders\n* previous history of significant GI resection\n* inability to swallow or defecate when asked"}, 'identificationModule': {'nctId': 'NCT01081457', 'acronym': 'SCP-Comodig', 'briefTitle': 'Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': "Effect of Deep Brain Stimulation on Voluntary and Involuntary Gastrointestinal Motility in Parkinson's Disease", 'orgStudyIdInfo': {'id': '2008/163/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ON', 'description': 'Stimulator switched ON', 'interventionNames': ['Device: Deep brain stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'OFF', 'description': 'Stimulator switched OFF', 'interventionNames': ['Device: Deep brain stimulation']}], 'interventions': [{'name': 'Deep brain stimulation', 'type': 'DEVICE', 'description': 'Comparison ON vs OFF', 'armGroupLabels': ['OFF', 'ON']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Guillaume GOURCEROL', 'investigatorAffiliation': 'University Hospital, Rouen'}}}}