Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT01936558
Status:
UNKNOWN
Last Update Posted:
2014-01-16
First Post:
2013-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Origin of Phantom Limb Sensation and Phantom Limb Pain in Amputees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-14', 'studyFirstSubmitDate': '2013-05-01', 'studyFirstSubmitQcDate': '2013-09-03', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting functional MR images', 'timeFrame': 'one year', 'description': 'The resting fMRI images will be obtained before and after the far infrared exposed to the phantom limb site. The default mode of the brain will be analyzed. If the default mode was changed, it was one of the evidence that the neural signal was transmitted from the phantom limb site into the brain and caused the change.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Exposure to Infrared Radiation']}, 'descriptionModule': {'briefSummary': "With the far infrared ray applied to the 'phantom limbs' in amputees and the corresponding normal legs in healthy subjects, the sensation of (phantom) limb will be assessed for each subject using the techniques of fMRI and meridian response.", 'detailedDescription': "This project will investigate two main hypotheses based on our previous studies on phantom limb sensation and phantom limb pain. The first hypothesis states that phantom limb sensation and phantom limb pain both correlate with the 'phantom limb', while the second one maintains that the phantom limb can interact with the patient's body by means of the meridian system. With the far infrared ray applied to the 'phantom limbs' in amputees and the corresponding normal legs in healthy subjects, the sensation of (phantom) limb will be assessed for each subject using the techniques of fMRI and meridian response. By analyzing the data collected from both groups, the investigators expect both hypotheses will be supported by the results of experiments in this project."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Amputees / healthy subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Amputees: at least one arm or one leg amputated\n* Healthy subjects: healthy person under 30 years old\n\nExclusion Criteria:\n\n* with mental diseases'}, 'identificationModule': {'nctId': 'NCT01936558', 'briefTitle': 'The Origin of Phantom Limb Sensation and Phantom Limb Pain in Amputees', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Origin of Phantom Limb Sensation and Phantom Limb Pain in Amputees', 'orgStudyIdInfo': {'id': '201210078RIC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Amputees', 'description': 'Amputee with one arm or one leg amputated/ Far infrared ray to the phantom limb site', 'interventionNames': ['Other: Far infrared ray to the sole']}, {'label': 'Healthy subjects', 'description': 'Healthy subjects under 30 years old/ Far infrared ray to the sole', 'interventionNames': ['Other: Far infrared ray to the sole']}], 'interventions': [{'name': 'Far infrared ray to the sole', 'type': 'OTHER', 'description': 'exposure 40-minute far infrared ray to the sole for each person/amputee.', 'armGroupLabels': ['Amputees', 'Healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'ChiYu Huang', 'role': 'CONTACT', 'email': 'chiyuhuang@ntu.edu.tw'}], 'facility': 'NTUH department of orthopedics; NTU department of electrical engneering', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Chi-Yu Huang', 'role': 'CONTACT', 'email': 'chiyuhuang@ntu.edu.tw'}], 'overallOfficials': [{'name': 'Rong-Sen Yang', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of orthopedics, NTUH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}