Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-03-14 @ 7:29 AM
Study NCT ID:
NCT02929732
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2016-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Sympathetic Activity in Willis-Ekbom Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012148', 'term': 'Restless Legs Syndrome'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-10-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2016-10-07', 'studyFirstSubmitQcDate': '2016-10-07', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac sympathetic activity measurement by the 123I-metaiodobenzylguanidine (123I-MIBG) scintigraphy. Analysis of 123I-MIBG uptake based on the ratio heart/mediastinum', 'timeFrame': 'Day 0'}], 'secondaryOutcomes': [{'measure': 'Cardiac sympathetic activity measurement by the 123I-metaiodobenzylguanidine (123I-MIBG) scintigraphy. Analysis of 123I-MIBG washout.', 'timeFrame': 'Day 0'}, {'measure': 'Analysis of circadian variations of blood pressure and heart rate assessed by the 24-hour ambulatory blood pressure monitoring', 'timeFrame': 'Day 0'}, {'measure': 'Measurement of pro inflammatory biomarkers and urinary catecholamines levels', 'timeFrame': 'Day 0'}, {'measure': '5) Analysis of mean increases of blood pressure and heart rate based on sleep stages, micro-arousals, periodic limb movements and sleep apnoeas as measured by continuous non-invasive blood pressure monitoring', 'timeFrame': 'Day 0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Willis-Ekbom Disease', 'Restless Legs Syndrome']}, 'descriptionModule': {'briefSummary': 'Willis-Ekbom disease (WED), also known as restless legs syndrome (RLS) is a common neurological sensorimotor disorder that typically impairs sleep and quality of life, likely consequent to a central dopaminergic dysfunction associated to brain iron deficiency. Periodic limb movements (PLMS) in sleep are present in 80% of patients with WED. PLMS are often associated with micro-arousals that contribute to sleep fragmentation and repeated increases of blood pressure and heart rate throughout the night, thus representing an increased risk for hypertension and cardiovascular diseases (CVD).\n\nWillis-Ekbom disease affects people with higher cardiovascular risk factors, such as advanced age, obesity, diabetes mellitus and hypercholesterolemia. However, previous observational, cross-sectional or longitudinal population-based studies on the association between RLS and CVD and hypertension showed controversial results.\n\nWhile the pathophysiology of RLS is yet to be elucidated and is likely multifactorial, one theory involves a reduction in dopaminergic outflow to the preganglionic sympathetic neurons in the dorsal horn of the spinal cord. Dopamine inhibits preganglionic sympathetic neurons, therefore a reduction in dopamine may in turn increase sympathetic outflow.\n\nBased on this notion, the investigators hypothesize an increase of sympathetic autonomic activity in Willis-Ekbom disease responsible for the recurrent increase in blood pressure and heart rate during sleep, which may play a role in increasing the risk of cardiovascular diseases.\n\nThe aim of this study is to analyze the autonomic nervous activity in patients with WED compared to healthy volunteers controls. The investigators will measure primarily the cardiac sympathetic activity by the 123I-metaiodobenzylguanidine (123I-MIBG) scintigraphy and secondarily the sympathetic nerve activity by the plasmatic pro inflammatory biomarkers and urinary catecholamine levels and the circadian variation of blood pressure and heart rate as assessed by the 24-hour ambulatory blood pressure monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-specific inclusion criteria (CASE + CONTROL)\n\n * 18 years-old or more, and less than 75 years-old\n * French-speaking\n * able to understand the study\n * signed written informed consent\n * affiliated to social security\n* CASE-specific inclusion criteria\n\n * 5 " International RLS Study Group (IRLSSG) 2012 " positive criteria\n * RLS severity scale (IRLS) score ≥ 15\n * ferritin \\> 50 ng/ml\n * periodic limb movements index \\> 10/hour\n * idiopathic (or primary) Willis-Ekbom disease not treated with dopaminergic agonists or pregabalin or gabapentin in the last 8 days, at least 3 years of disease duration with symptoms recurring at least 3 times a week\n\nExclusion Criteria:\n\n* Non-specific exclusion criteria (CASE + CONTROL)\n\n * vulnerable subject : subject deprived of liberty or protected by law (trusteeship, legal guardianship), pregnant or breastfeeding woman\n * exclusion period after other research protocol\n * malignant neoplastic disease treated in the last 12 months\n * medical history of cardiovascular disease (ischemic heart disease, heart failure, stroke, hypertension, sleep apnea syndrome)\n * antidepressant, neuroleptic, sympathomimetic, sympatholytic, vasculotropic, dopamine agonists, opiate treatments\n* CASE-specific exclusion criteria\n\n \\- restless legs syndrome secondary to renal failure, hemochromatosis, neurologic disorders, iatrogenesis\n* CONTROL-specific exclusion criteria - Willis-Ekbom Disease'}, 'identificationModule': {'nctId': 'NCT02929732', 'acronym': 'MIBG-RLS', 'briefTitle': 'Analysis of Sympathetic Activity in Willis-Ekbom Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Analysis of Sympathetic Activity in Willis-Ekbom Disease', 'orgStudyIdInfo': {'id': 'RECHMPL16_0056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Willis-Ekbom disease patients (CASE)', 'interventionNames': ['Other: Sympathetic nervous activity measurement']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers (CONTROL)', 'interventionNames': ['Other: Sympathetic nervous activity measurement']}], 'interventions': [{'name': 'Sympathetic nervous activity measurement', 'type': 'OTHER', 'description': 'Polysomnography, MIBG myocardic scintigraphy, and 24h blood pressure measurement', 'armGroupLabels': ['Healthy volunteers (CONTROL)', 'Willis-Ekbom disease patients (CASE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yves Dauvilliers, PhD', 'role': 'CONTACT', 'email': 'y-dauvilliers@chu-montpellier.fr', 'phone': '+33467336361'}], 'facility': 'University Hospital of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}