Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-07 @ 11:49 PM
Study NCT ID:
NCT02901002
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2016-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body Perception and Complex Regional Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-16', 'studyFirstSubmitDate': '2016-09-05', 'studyFirstSubmitQcDate': '2016-09-09', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensory testing', 'timeFrame': 'day 1', 'description': 'areas of the hand where spontaneous sensations were felt'}], 'secondaryOutcomes': [{'measure': 'Neurological evaluation by questionary', 'timeFrame': 'day 1', 'description': 'Score to HAD (anxiety-depression) scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Complex Regional Pain Syndromes', 'Pain', 'Spontaneous sensations', 'interoception'], 'conditions': ['Complex Regional Pain Syndromes']}, 'descriptionModule': {'briefSummary': 'In CRPS, perturbation of body image and pseudo-neglect syndrome of the body part affected are frequently found. Pain and sensory perturbation seems to modify the way patients perceived their body part affected.\n\nDoes a local body image perturbation can affect the balanced of the global self-awareness?', 'detailedDescription': 'With the investigation of spontaneous sensations (SPS) according to the protocol of Michael and al (2011) the investigators study how patients can listen to their internal sensations located in other body part than the painful member in order to construct a representation of the body and maintain it in active consciousness. A group of controls will be included to understand if there is a global modification in the perception of SPS witch may be linked to the pathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from CRPS of the lower limb and Healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For patients:\n\n • a diagnosis of CRPS of the lower limb according to the Budapest Criteria (men or women) For patients and control group\n* Age ≥ 18 years\n\nExclusion Criteria:\n\nFor patients and control group\n\n* neurological disease with cerebral repercussion or not stabilized serious physical illness;\n* psychotropic medication\n* disorders related to the use of a psychoactive substance (abuse, dependence or withdrawal);\n\n * For patients:\n* Presence of an other pain disorder'}, 'identificationModule': {'nctId': 'NCT02901002', 'acronym': 'SDRC', 'briefTitle': 'Body Perception and Complex Regional Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Body Perception and Complex Regional Pain Syndrome : a Case-control Study', 'orgStudyIdInfo': {'id': '1608097'}, 'secondaryIdInfos': [{'id': '2016-A01248-43', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient', 'description': 'Patients suffering from CRPS of the lower limb Patients with sensory testing in the two hand and neuropsychological evaluation', 'interventionNames': ['Other: Sensory testing in the two hand', 'Other: Neuropsychological evaluation']}, {'label': 'Control', 'description': 'Healthy controls match by age, gender, Body Mass Index Healthy volunteers with sensory testing in the two hand and neuropsychological evaluation', 'interventionNames': ['Other: Sensory testing in the two hand', 'Other: Neuropsychological evaluation']}], 'interventions': [{'name': 'Sensory testing in the two hand', 'type': 'OTHER', 'description': 'spontaneous sensations while watching a hand', 'armGroupLabels': ['Control', 'Patient']}, {'name': 'Neuropsychological evaluation', 'type': 'OTHER', 'description': 'Score to anxiety-depression scale', 'armGroupLabels': ['Control', 'Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': "Christelle CREAC'H, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}