Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT06010251
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2023-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Utility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'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': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2023-08-18', 'studyFirstSubmitQcDate': '2023-08-18', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI)', 'timeFrame': 'Baseline, up to 4 weeks', 'description': 'The NPSI is a self-reported, validated questionnaire that includes 10 items (on different pain sensations, e.g., burning, squeezing, electric-shock, etc.) used to evaluate the properties of neuropathic pain. Each item is scored on an 11-point NRS (0 meaning no symptom and 10 meaning worst symptom), with higher scores indicating more severe neuropathic pain symptoms.'}, {'measure': 'Change in neuropathic pain interference assessed by pain interference questionnaire.', 'timeFrame': 'Baseline, up to 4 weeks', 'description': 'The questionnaire consists in a numerical rating of pain interference ranging from 0= No Interference to 10=Extreme interference with activities, mood and sleep'}, {'measure': 'Changes associated with sensory function/dysfunction assessed by quantitative sensory testing', 'timeFrame': 'Baseline, up to 4 weeks', 'description': 'The sensory test assesses thermal thresholds and includes:\n\ncool detection threshold (CDT), warm detection threshold (WDT), cold pain threshold (CPT), hot pain threshold (HPT), all performed using the method of limits: 0 to 50 Celsius (ºC) all values will be reported in Celsius.'}], 'secondaryOutcomes': [{'measure': 'Change in manageable pain assessed by days of manageable pain questionnaire.', 'timeFrame': 'Baseline, up to 4 weeks', 'description': 'This item specifies the total number of days with pain during the last 7 days, including today, and the response categories ranges from 0=none to 7=seven days.'}, {'measure': 'Changes of psychosocial assessed by Multidimensional Pain Inventory (pain severity subscale)', 'timeFrame': 'Baseline, up to 4 weeks', 'description': 'Multidimensional Pain Inventory assesses the psychosocial impact of pain. This scale consists of three questions: 1) pain at the present moment; 2) pain during the past week and 3) suffering because of pain.\n\nThe range of the responses are from 0 (no pain or suffering) to 6 (extreme pain or suffering) and the scores of these three questions will be summed to obtain a composite pain severity score.'}, {'measure': 'Change in Global impression of changes by PGIC questionnaire', 'timeFrame': 'Baseline, up to 4 weeks', 'description': 'Patients\' Global Impression of Changes (PGIC) assesses patients\' perceptions of changes following treatment. It is a 7-point verbal scale, with the options ranging from "very much improved" (3), "much improved" (2), "minimally improved" (1), "no change" (0), "minimally worsened" (-1) "much worsened" (-2), and "very much worsened" (-3).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries', 'Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effectiveness of bodily illusions combined with transcranial direct current stimulation (tDCS) on neuropathic pain symptoms and sensory functions in participants with spinal cord injury (SCI) and neuropathic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The study will be open to people of any ethnicity, racial background, and gender.\n\nInclusion criteria:\n\nSCI with Pain:\n\n1. Men or women\n2. fluent in English\n3. 18-70 years of age who have: (3a) Complete and incomplete SCI, level of injury (above L1); (3b) Persistent neuropathic pain started after the injury for a minimum of three months prior to entering the study that is at least moderate in severity, defined as ≥ 4 on a Numeric Rating Scale (NRS) ranging 0 to 10.\n\nExclusion criteria:\n\nParticipants will be excluded if they have:\n\n1. Major psychiatric disease/disorder (self-reported);\n2. a significant neurological trauma (self-reported) other than SCI;\n3. a recent (one-year) history of alcohol or drug abuse assessed by the Drug Abuse Screening Test (DAST-10)\n4. history of visual and hearing loss not corrected\n5. history of epilepsy or seizures\n6. any metal implants in the head, or implanted devices such as cochlea implants or cardiac pacemakers.\n\nWe will not include any special population like:\n\nAdults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners'}, 'identificationModule': {'nctId': 'NCT06010251', 'briefTitle': 'Utility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Mechanisms and Utility of Multisensory Body- Representation in SCI and SCI-Related Neuropathic Pain', 'orgStudyIdInfo': {'id': '20230447'}, 'secondaryIdInfos': [{'id': 'SC220073', 'type': 'OTHER_GRANT', 'domain': 'CDMRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCI with pain', 'description': 'Participants will undergo 2-4 weeks of combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions (10 sessions total).', 'interventionNames': ['Other: tDCS and bodily illusions']}], 'interventions': [{'name': 'tDCS and bodily illusions', 'type': 'OTHER', 'description': 'Participants will be required to perform (in person) 10 interventions over a time frame of 2-4 weeks. They can perform this everyday or for a minimum of 2-3 times per week over 4 weeks.\n\nTwo types of illusions will be used 15 min each, the rubber hand illusion and the walking illusion to target upper and lower limbs. These procedures will impact the body representation of the participants resulting in bodily illusions.', 'armGroupLabels': ['SCI with pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eva Widerstrom-Noga, PhD', 'role': 'CONTACT', 'email': 'ewiderstrom-noga@med.miami.edu', 'phone': '305-243-7125'}, {'name': 'Roberta Vastano, PhD', 'role': 'CONTACT', 'email': 'rxv331@miami.edu', 'phone': '7542073627'}, {'name': 'Eva Widerstrom-Noga, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Roberta Vastano, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Eva Widerstrom-Noga, PhD', 'role': 'CONTACT', 'email': 'ewiderstrom-noga@med.miami.edu', 'phone': '(305)243-7125'}, {'name': 'Roberta Vastano, PhD', 'role': 'CONTACT', 'email': 'rxv331@miami.edu', 'phone': '754 207 3627'}], 'overallOfficials': [{'name': 'Eva Widerstrom-Noga, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eva Widerstrom-Noga', 'investigatorAffiliation': 'University of Miami'}}}}