Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT02985294
Status:
UNKNOWN
Last Update Posted:
2018-08-23
First Post:
2016-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripheral Physiological Measures as Determinants of Pain Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D059348', 'term': 'Peripheral Nerve Injuries'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'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': '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electrophysiological pain phenotypes using MEM. Pain biomarker', 'timeFrame': 'Single assessment (cross sectional study) at the first and only visit', 'description': 'Correlate with parameters of clinical pain and of pain processing in existing pain patients'}, {'measure': 'Electrophysiological pain phenotypes using MEM. Pain predictor', 'timeFrame': 'Single assessment at baseline, before any procedure (surgery/chemotherapy)', 'description': 'Predict development of neuropathic pain in susceptible patients'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neuropathic pain', 'Quantitative Sensory Testing', 'Multiple Excitability Measures', 'Threshold Tracking'], 'conditions': ['Polyneuropathies', 'Peripheral Nerve Injuries', 'Peripheral Nervous System Diseases', 'Chemotherapy Effects', 'Neuralgia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://dolorisk.eu/', 'label': 'Official Consortium web site'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates peripheral nervous system function using Multiple Excitability Measures (MEM) to obtain "electrophysiological pain phenotypes"', 'detailedDescription': 'Using MEM for peripheral sensory and motor axons we want to identify a set of excitability measures that:\n\n1. Correlate with parameters of clinical pain and of pain processing in existing pain patients (cross sectional study), with the aim to obtain an objective Pain Biomarker.\n2. Predict development of neuropathic pain in susceptible patients (longitudinal study). Neuropathic Pain Predictor for patients:\n\ni. Undergoing surgical procedures associated with a relatively high risk of developing neuropathic pain such as thoracotomy and hernia repair ii. Planning to start chemotherapy with potentially neurotoxic agents such as vincristine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. Painless patients and patients with chronic peripheral neuropathic pain\n2. Susceptible patients for developing pain i. Undergoing surgical procedures associated with a relatively high risk of developing neuropathic pain such as thoracotomy and hernia repair ii. Planning to start chemotherapy with potentially neurotoxic agents such as taxol, vincristine, etc.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic peripheral neuropathic pain\n* Painless Patient with risk to develop neuropathic pain (post-surgery, chemotherapy-induced)\n\nExclusion Criteria:\n\n* Minors'}, 'identificationModule': {'nctId': 'NCT02985294', 'acronym': 'DOLORiskWP51', 'briefTitle': 'Peripheral Physiological Measures as Determinants of Pain Risk', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neuroscience Technologies SLP, Barcelona'}, 'officialTitle': 'DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - Peripheral Physiological Measures as Determinants of Pain Risk', 'orgStudyIdInfo': {'id': 'Neuroscience Technologies'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cross-sectional cohort', 'description': 'Multiple Excitability Measures of peripheral nerves on patients with chronic peripheral neuropathic pain', 'interventionNames': ['Other: Multiple Excitability Measures of peripheral nerves']}, {'label': 'Longitudinal cohort', 'description': 'Multiple Excitability Measures of peripheral nerves on painless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, surgery)', 'interventionNames': ['Other: Multiple Excitability Measures of peripheral nerves']}], 'interventions': [{'name': 'Multiple Excitability Measures of peripheral nerves', 'type': 'OTHER', 'otherNames': ['Assessment of sensory phenotype by QST (quantitative sensory testing)', 'Questionnaires'], 'description': "The technique of threshold tracking can be used to obtain several measures of peripheral nerve excitability (Multiple Excitability Measures or MEM), such as refractoriness, supernormality, strength-duration time constant and 'threshold electrotonus' (i.e. the changes in threshold produced by long-lasting depolarizing or hyperpolarizing current pulses). Each of these measurements depends on membrane potential and on other biophysical properties of the axons. Many of these excitability parameters are very constant among different subjects, while other, such as the current/threshold parameters and the super/sub-excitability parameters, appear to be characteristic of an individual", 'armGroupLabels': ['Cross-sectional cohort', 'Longitudinal cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08028', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Romà Solà, MD', 'role': 'CONTACT', 'email': 'rsola@nsc-tec.com', 'phone': '0034 93 4020164'}], 'facility': 'Neuroscience technologies', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Romà Solà, MD', 'role': 'CONTACT', 'email': 'rsola@nsc-tec.com', 'phone': '0034 934020164'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuroscience Technologies SLP, Barcelona', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Oxford', 'class': 'OTHER'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'University of Aarhus', 'class': 'OTHER'}, {'name': 'University of Dundee', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}