Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT05161767
Status:
TERMINATED
Last Update Posted:
2024-01-12
First Post:
2021-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shifting Away From Pain: Neurocognitive Approach to Explain and Predict Recovery Following Whiplash Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014911', 'term': 'Whiplash Injuries'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D019838', 'term': 'Neck Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': 'D059906', 'term': 'Neuroimaging'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Difficult recruitment of acute patients via emergency services due to COVID-19. The required sample size was consequently not reached within the PhD period of the involved researchers.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2021-12-03', 'studyFirstSubmitQcDate': '2021-12-03', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state', 'timeFrame': 'Baseline and 6-months follow-up', 'description': 'Change between baseline assessment (within 4 weeks after the trauma) and the 6-months follow-up assessment.'}, {'measure': 'Structural MRI measures (i.e., grey and white matter)', 'timeFrame': 'Baseline and 6-months follow-up', 'description': 'Change between baseline assessment (within 4 weeks after the trauma) and the 6-months follow-up assessment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['whiplash', 'chronic pain', 'neuroimaging'], 'conditions': ['Whiplash Injuries']}, 'descriptionModule': {'briefSummary': 'Around half of the patients with neck pain after trauma (whiplash) will develop chronic pain. Understanding the transition from acute to chronic pain after whiplash is a priority since will help to identify those which patients are likely to fully recover and who do not. In the last years, there have been a call for an investigation of new biomarkers; particularly in brain structure and function. Alterations in the structure of the brain (gray matter, white matter and cortical thickness) as well as the brain function have been found in people with chronic WAD; which are also correlated with pain, disability and symptoms of central sensitization such as hyperalgesia. Previous research has found structural and functional brain differences between people who develop chronic low back pain compared to those who recovered; but research in this vein is still lacking in people with whiplash. Consequently, this study aims to examine the neural correlates of recovery following whiplash injury.', 'detailedDescription': 'This study aims to investigate whether or not there are differences in brain structure and function between people who recover after whiplash and those who do not. Thus, patients with acute neck pain after whiplash will be recruited. Also, a pain-free age- and sex-matched control group will be recruited for comparison.\n\nA longitudinal prospective study will be conducted with two follow-up measurements (3 and 6 months). All measurements will take place at University Hospital of Ghent (UZ Gent), Ghent (Belgium). MRI measures will be taken at baseline (\\<4 weeks after the accident) and 6-months follow-up. The 3-months follow-up will only consist of the assessment of the online questionnaires; so, patients will not be required to come to UZ Gent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Whiplash injury is a type of neck injury caused by sudden movement of the head forwards, backwards or sideways (i.e. motor vehicle accident)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Whiplash patients\n\nInclusion Criteria:\n\n* Neck pain within 4 weeks after the trauma\n* Native Dutch speaker\n* Refraining from consuming caffeine, alcohol and nicotine in the hour before the MRI scans in both measurement times\n\nExclusion Criteria:\n\n* Neuropathic pain\n* Being pregnant\n* A history of a chronic pain syndrome\n* Chronic fatigue syndrome\n* Fibromyalgia\n* Cardiovascular disorders\n* Epilepsy\n* Endocrinological disorders\n* Rheumatic disorders\n* Psychiatric disorders\n* History of neck surgery\n* Loss of consciousness during/after the whiplash trauma\n* MRI incompatible health condition (e.g., pacemaker, metal prosthetic devices)\n* Claustrophobia.\n\nHealthy volunteers: (matched for age and gender). Additional exclusion criteria include for healthy volunteers\n\n* a history of a chronic pain syndrome\n* a pain condition in the last six months for which treatment was sought'}, 'identificationModule': {'nctId': 'NCT05161767', 'briefTitle': 'Shifting Away From Pain: Neurocognitive Approach to Explain and Predict Recovery Following Whiplash Injury', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Shifting Away From Pain: Neurocognitive Approach to Explain and Predict Recovery Following Whiplash Injury', 'orgStudyIdInfo': {'id': 'B670201941074'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Recovered group', 'description': 'This will group will consists of people who have a remission of their symptoms at 6-months follow-up after whiplash injury.', 'interventionNames': ['Diagnostic Test: Brain MRI (neuroimaging)']}, {'label': 'non-recovered group', 'description': 'This will group will consists of people who develop persistent symptoms at 6-months follow-up after whiplash injury.', 'interventionNames': ['Diagnostic Test: Brain MRI (neuroimaging)']}], 'interventions': [{'name': 'Brain MRI (neuroimaging)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Structural and functional brain scans will be taken.', 'armGroupLabels': ['Recovered group', 'non-recovered group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Department of rehabilitation sciences (Ghent University)', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Iris Coppieters, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vrije Universiteit Brussel, KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}