Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT05545358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-09-19
First Post:
2022-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neural Bases of Phantom Pain After Amputation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010591', 'term': 'Phantom Limb'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2022-09-16', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in brain activity, measured through fMRI, following proprioceptive training', 'timeFrame': 'Up to 3 months', 'description': 'Brain activity (BOLD hemodynamic response) will be measured via fMRI before and after proprioceptive training sessions.'}, {'measure': 'Change in spinal cord activity, measured through spinal fMRI, following proprioceptive training', 'timeFrame': 'Up to 3 months', 'description': 'Spinal cord activity (BOLD hemodynamic response) will be measured via spinal fMRI before and after proprioceptive training sessions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fMRI', 'spinal fMRI'], 'conditions': ['Phantom Pain']}, 'descriptionModule': {'briefSummary': "The amputation of a limb results in chronic pain associated with the lost limb in the majority of patients, which persists over time. Despite a large number of studies conducted in an attempt to elucidate the neural basis of phantom pain, these are still not elucidated and current treatments often fail to relieve patients' pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population is composed of :\n\n* patients who have been amputated for more than 2 years and have chronic phantom pain;\n* patients who have been amputated for more than 2 years and do not have chronic phantom pain;\n* healthy participants with no neurological history. The patients will be recruited from the cohort of amputee patients followed by the Physical Medicine and Rehabilitation departments of the Hôpital d'Instruction des Armées Laveran, the Hôpital d'Instruction des Armées Desgenettes and the CHU de Saint-Etienne.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 65 years old\n* For the "amputees with phantom pain" group: patients who have been amputated for more than 2 years and have chronic phantom pain\n* For the "amputees without phantom pain" group: patients who have been amputated for more than 2 years and do not have chronic phantom pain\n* For the "healthy participants" group: healthy participants with no neurological history\n\nExclusion Criteria:\n\n* Clinically significant pathology (gastrointestinal, renal, hepatic, endocrine, cardiovascular or respiratory)\n* Progressive psychiatric or neurological pathology\n* On psychotropic medication\n* Pregnant or nursing woman\n* Inadequate level of French language'}, 'identificationModule': {'nctId': 'NCT05545358', 'acronym': 'Phantom limb', 'briefTitle': 'Neural Bases of Phantom Pain After Amputation', 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': 'Experimental Study of the Neural Bases of Phantom Pain After Amputation and Their Modification by Proprioceptive Training: MRI Study of the Brain and Spinal Cord', 'orgStudyIdInfo': {'id': '2020PPRC09'}, 'secondaryIdInfos': [{'id': '2021-A01733-38', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Amputees with phantom pain', 'description': 'Adult patients who have been amputated for more than 2 years and have chronic phantom pain', 'interventionNames': ['Other: Questionnaires', 'Device: Brain and Spinal Cord functional Magnetic Resonance Imaging', 'Other: Proprioceptive training']}, {'label': 'Amputees without phantom pain', 'description': 'Adult patients who have been amputated for more than 2 years and do not have chronic phantom pain', 'interventionNames': ['Other: Questionnaires', 'Device: Brain and Spinal Cord functional Magnetic Resonance Imaging']}, {'label': 'Healthy participants', 'description': 'Healthy adult participants with no neurological history', 'interventionNames': ['Device: Brain and Spinal Cord functional Magnetic Resonance Imaging', 'Other: Proprioceptive training']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': "Short-Form McGill Pain Questionnaire (SF-MPQ) Pain Disability Index (PDI) Prosthesis Evaluation Questionnaire (PEQ) Psychological Inflexibility to Pain Scale (PIPS) Chronic Pain Acceptance Questionnaire (CPAQ) Cognitive Difficulties Scale (CDS) Amputee Body Image Scale (ABIS) Trinity Amputation and Prosthesis Experience Scales (TAPES) Pain Catastrophizing Scale (PCS) Hospital Anxiety and Depression Scale (HAD) Credibility/Expectancy Questionnaire (CEQ) Short-Form Edinburgh Handedness Inventory (SF-EHI) Patient's Global Impression of Change (PGIC)", 'armGroupLabels': ['Amputees with phantom pain', 'Amputees without phantom pain']}, {'name': 'Brain and Spinal Cord functional Magnetic Resonance Imaging', 'type': 'DEVICE', 'description': 'Brain and Spinal Cord functional Magnetic Resonance Imaging', 'armGroupLabels': ['Amputees with phantom pain', 'Amputees without phantom pain', 'Healthy participants']}, {'name': 'Proprioceptive training', 'type': 'OTHER', 'description': 'Proprioceptive muscular training via a mechanical vibration of low amplitude and frequency between 60 and 80 Hz applied to the tendons.', 'armGroupLabels': ['Amputees with phantom pain', 'Healthy participants']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}