Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT04007302
Status:
COMPLETED
Last Update Posted:
2019-07-08
First Post:
2019-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-03', 'studyFirstSubmitDate': '2019-07-01', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of prefrontal cortex activity', 'timeFrame': 'Day 1', 'description': 'Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar\\*cm)'}, {'measure': 'measurement of prefrontal cortex activity', 'timeFrame': 'Day 2', 'description': 'Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar\\*cm)'}], 'secondaryOutcomes': [{'measure': 'assessment of average pain', 'timeFrame': 'Inclusion', 'description': 'analogical visual and numerical scale (0, no pain - 10 max pain)'}, {'measure': 'assessment of average pain', 'timeFrame': 'Day 1', 'description': 'analogical visual and numerical scale (0, no pain - 10 max pain)'}, {'measure': 'assessment of average pain', 'timeFrame': 'Day 2', 'description': 'analogical visual and numerical scale (0, no pain - 10 max pain)'}, {'measure': 'measurement of the distance travelled', 'timeFrame': 'Inclusion', 'description': 'meters'}, {'measure': 'measurement of the distance travelled', 'timeFrame': 'Day 1', 'description': 'meters'}, {'measure': 'measurement of the distance travelleddistraction.', 'timeFrame': 'Day 2', 'description': 'meters'}, {'measure': 'Observe a decrease in perceived effort with virtual reality distraction.', 'timeFrame': 'Inclusion', 'description': "Borg's scale (0-10)"}, {'measure': 'measurement of perceived effort', 'timeFrame': 'Day 1', 'description': "Borg's scale (0-10)"}, {'measure': 'measurement of perceived effort', 'timeFrame': 'Day 2', 'description': "Borg's scale (0-10)"}, {'measure': 'measurement of perceived effort', 'timeFrame': 'Day 1', 'description': 'IPQ questionary (-3 ; +3)'}, {'measure': "Quantify patients' adherence (presence) to the virtual environment", 'timeFrame': 'Day 2', 'description': 'IPQ questionary (-3 ; +3)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this work is that distraction is an effective way to modify the feeling and experience of chronic lumbar pain by modifying the functioning of the prefrontal cortex.\n\nThe main objective of this study is to show that during chronic low back pain generated during physical exercise, virtual reality distraction leads to the modification of the activity of the prefrontal cortex.\n\nThe secondary objectives are:\n\n* Show a significant decrease in the average pain assessed with EVA during physical exercise with virtual reality distraction.\n* Show an increase in the distance travelled with virtual reality distraction.\n* Observe a decrease in perceived effort with virtual reality distraction.\n* Quantify the adherence (presence) of subjects to the virtual environment', 'detailedDescription': "A pre-test phase at D0 will be carried out with the objective of individually determining the exercise conditions (speed and slope) of walking that will generate lumbar pain. Patients who have not experienced lumbar pain during this phase will be excluded from the study. The patients included are then randomized according to the order of physical exercise situations.\n\nFor the tests, patients will be equipped with a miniaturized wireless (Octamon, Artinis) and multi-channel (8 optodes) NIRS device placed on the patient's frontal lobe according to EEG 10-20 positioning (fig. 2). They will then be placed on an inclined treadmill according to the angle that caused the pain during the pre-test.\n\nDuring the test, subjects will walk to the voluntary stop and the different reasons for the stop (feeling of fatigue, pain, etc.) will be recorded by visual analogue scales and questionnaires. The duration of the exercise will be measured by a digital stopwatch connected to the treadmill. During physical exercise, the bilateral activity of the prefrontal cortex will be recorded continuously at a sampling frequency of 10 Hz.\n\nFor each test, subjects will be confronted with 2 situations, on D1 and D2. In a situation, walking will be done without distraction. In the other situation, the patient will be placed in front of a screen with virtual reality simulation while performing the walking exercise."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given free and informed consent and signed the consent\n* The patient must be a member or beneficiary of a health insurance plan\n* The patient is available for a 3-day follow-up\n* The patient is between 18 and 75 years old\n* Disabling lumbar pain beyond three months\n\nExclusion Criteria:\n\n* Subject participates in another intervention study\n* Subject is in an exclusion period determined by a previous study\n* The subject is under the protection of justice, guardianship or curatorship\n* Subject refuses to sign consent\n* It is impossible to provide informed information about the subject\n* The subject is unable to complete the study questionnaires\n* The patient is pregnant, parturient, or breastfeeding\n* The subject has a contraindication (or incompatible drug combination) for a treatment required for this study\n* Recent involuntary weight loss\n* Inflammatory schedule pain (predominantly nocturnal, requiring early morning rusting, improved by physical activity)\n* Associated fever,\n* Saddle anaesthesia\n* Vesico-sphincterial disorders\n* Typical root symptoms\n* Systemic corticosteroid therapy\n* History of cancer\n* History of spinal trauma\n* History of intravenous drug use\n* Systemic corticosteroid therapy\n* Surgical intervention of the spine or lower limbs\n* Painful pathology of the lower limbs (coxarthrosis, gonarthrosis, vascular claudication or neurogenic when walking).\n\nExclusion criteria:\n\n● Taking prescribed analgesic treatment after the inclusion procedure.'}, 'identificationModule': {'nctId': 'NCT04007302', 'acronym': 'NGUYEN', 'briefTitle': 'Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': "Modification de l'activité du Cortex préfrontal Induite Par Distraction en réalité Virtuelle Chez le Sujet Lombalgique Chronique.", 'orgStudyIdInfo': {'id': 'LOCAL 2017/DMNG-01'}, 'secondaryIdInfos': [{'id': '2017-A02958-45', 'type': 'OTHER', 'domain': 'ANSM, France'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'walking with distraction', 'description': 'the patient walks in front of a screen with virtual reality simulation', 'interventionNames': ['Other: measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy)', 'Other: completion of questionnaires', 'Other: completion of questionnaires for pain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Walking without distraction', 'description': 'the patient walks on a treadmill without virtual reality simulation', 'interventionNames': ['Other: measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy)', 'Other: completion of questionnaires', 'Other: completion of questionnaires for pain']}], 'interventions': [{'name': 'measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy)', 'type': 'OTHER', 'description': 'measurement of the cerebral oxygenation response by the use of the Near Infrared Spectroscopy (NIRS) method', 'armGroupLabels': ['Walking without distraction', 'walking with distraction']}, {'name': 'completion of questionnaires', 'type': 'OTHER', 'description': 'igroup presence questionnaire (IPQ), Dallas Pain Questionnaire (DRAD), Fear-Avoidance Beliefs (FABQ) and Quebec Back Lumbago Scale', 'armGroupLabels': ['Walking without distraction', 'walking with distraction']}, {'name': 'completion of questionnaires for pain', 'type': 'OTHER', 'description': 'analogical visual and numerical scale and Borg scale', 'armGroupLabels': ['Walking without distraction', 'walking with distraction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30129', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Anissa MEGZARI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Nīmes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}