Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-27 @ 2:32 AM
Study NCT ID:
NCT05908266
Status:
RECRUITING
Last Update Posted:
2023-06-18
First Post:
2023-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flexible Reaching Control in Parkinson 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-08', 'studyFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2023-06-08', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kinematics', 'timeFrame': 'Measured during the entire experiment (an average of 4.5 years)', 'description': 'Position of the handle as a function of time. Units are millimetres'}, {'measure': 'Surface Electromyogram', 'timeFrame': 'Measured during the entire experiment (an average of 4.5 years)', 'description': 'Surface recordings of muscles activities from the main muscles involved in movement production. Units are volts'}, {'measure': 'Applied forces', 'timeFrame': 'Measured during the entire experiment (an average of 4.5 years)', 'description': 'Forces applied by participants on the robotic handle. Units are Newtons'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'Current research and theories have highlighted that the parameters linked to movement planning, e.g. the decision to select a movement goal, and adaptation, e.g. the ability to update control dependent on a novel dynamical context, are update quickly and within an ongoing movement in the general population. In parallel, it has been suggested that the evaluation of movement costs is a function of the basal ganglia, and it is impaired in Parkinson disease (PD). Here the investigators want to test whether these mechanisms also alter the ability of patients to update control during an ongoing action. A positive result would confirm that movement-related costs and dynamical representations depend on the integrity of the basal ganglia, in contrast a negative result would indicate that the deficit in PD is more specifically related to movement initiation, which would invite one to reconsider the cause of bradykinesia in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be based on two populations: on population of volunteers with Parkinson disease, and one population of age and sex matched healthy individuals.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to perform the task (assessed during the experiment)\n\nExclusion Criteria:\n\n* Inability to perform the task (motor) or to understand the task requirements (cognitive)'}, 'identificationModule': {'nctId': 'NCT05908266', 'acronym': 'REACH-PD', 'briefTitle': 'Flexible Reaching Control in Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'Université Catholique de Louvain'}, 'officialTitle': 'Behavioural Study of Reaching Control in Healthy Volunteers and Volunteers With Parkinson Disease in Dynamical Context', 'orgStudyIdInfo': {'id': 'REACH-PD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PD', 'description': 'Patients with Parkinson disease', 'interventionNames': ['Other: Reaching movements', 'Other: Disease Assessment']}, {'label': 'Control', 'description': 'Healthy volunteers', 'interventionNames': ['Other: Reaching movements']}], 'interventions': [{'name': 'Reaching movements', 'type': 'OTHER', 'description': 'Participants will be instructed to perform reaching movements by moving the handle of a robotic arm mounted with a virtual reality display.', 'armGroupLabels': ['Control', 'PD']}, {'name': 'Disease Assessment', 'type': 'OTHER', 'description': 'Disease stage assessed by trained professionals', 'armGroupLabels': ['PD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1348', 'city': 'Louvain-la-Neuve', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'André Mouraux, PhD', 'role': 'CONTACT', 'email': 'andre.mouraux@uclouvain.be', 'phone': '+32 2 764 54 47'}], 'facility': 'Université catholique de Louvain', 'geoPoint': {'lat': 50.66829, 'lon': 4.61443}}], 'centralContacts': [{'name': 'André Mouraux, PhD', 'role': 'CONTACT', 'email': 'andre.mouraux@uclouvain.be', 'phone': '+32 2 764 54 47'}, {'name': 'Frédéric Crevecoeur, PhD', 'role': 'CONTACT', 'email': 'frederic.crevecoeur@uclouvain.be'}], 'overallOfficials': [{'name': 'Frédéric Crevecoeur, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}