Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 1:37 PM
Study NCT ID:
NCT04708392
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2020-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-04-09', 'mcpReleaseN': 2, 'releaseDate': '2024-03-13'}, {'resetDate': '2025-04-11', 'mcpReleaseN': 3, 'releaseDate': '2025-03-25'}], 'estimatedResultsFirstSubmitDate': '2024-03-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2021-01-11', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative Stimulus Testing (QST)-Thermal', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'Thermal stimulus testing - thermal stimulation system is used to record hot and cold sensation and pain thresholds.'}], 'secondaryOutcomes': [{'measure': 'McGill Pain Questionnaire (MPQ)', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'This outcome measurement tool contains 15 descriptive words (11 sensory and 4 affective) used by subjects to describe their pain. Total number of words chosen is documented'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'This measurement tool assesses functional outcome for 10 conditions in subjects with chronic pain. Patients select a statement for each condition that most closely resembles their own situation. Each statement has a score of 0-5, depending on the severity of the particular disability. Raw scores are calculated into a disability percentage.'}, {'measure': "Beck's Depression Inventory (BDI)", 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'This is a 21 section multiple-choice self-report survey. Patients select a statement in each section that most closely resembles their own situation. Each statement has a score of 0-3, depending on the severity of the depressive content. Raw scores are tallied.'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'This is a 13 question survey. It is used to assess the degree to which patients ruminate on, magnify, and/or amplify their pain symptoms. Patients rate on a scale of 0-4 (never - all the time) how often they have each of the thoughts listed. Raw scores are tallied'}, {'measure': 'Numerical Rating Scale (NRS)', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'Patients rate, on a scale of 0-10, their pain at it\'s least, most, and average over the past week. They also rate their pain "right now" as well as their perception of Global Improvement.'}, {'measure': 'Epworth Sleepiness Scale (ESS)', 'timeFrame': 'Change from baseline to 4 weeks', 'description': "This survey is used to assess the 'daytime sleepiness' of patients. Patients rate the likelihood of falling asleep during several daytime scenarios, on a scale of 0-3 (never - very likely). Raw scores are tallied."}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'This survey is designed to assess the nature, severity, and impact of insomnia in adults. Patients are asked to rate on a scale of 0-4 (no problem - very much a problem) how much of a problem they have with several sleep conditions. Raw scores are tallied.'}, {'measure': 'Quantitative Stimulus Testing (QST)-Sensitivity', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'Von Frey fibers are used to determine tactile sensitivity.'}, {'measure': 'Quantitative Stimulus Testing (QST)-Pressure', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'An algometer is used to measure pain related to pressure.'}, {'measure': 'Quantitative Stimulus Testing (QST)-Vibration', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'A tuning fork is used to measure sensitivity to vibration.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '28961366', 'type': 'BACKGROUND', 'citation': 'Deer T, Slavin KV, Amirdelfan K, North RB, Burton AW, Yearwood TL, Tavel E, Staats P, Falowski S, Pope J, Justiz R, Fabi AY, Taghva A, Paicius R, Houden T, Wilson D. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. doi: 10.1111/ner.12698. Epub 2017 Sep 29.'}, {'pmid': '27139915', 'type': 'BACKGROUND', 'citation': 'Hou S, Kemp K, Grabois M. A Systematic Evaluation of Burst Spinal Cord Stimulation for Chronic Back and Limb Pain. Neuromodulation. 2016 Jun;19(4):398-405. doi: 10.1111/ner.12440. Epub 2016 May 3.'}, {'pmid': '23321375', 'type': 'BACKGROUND', 'citation': 'De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb and back pain. World Neurosurg. 2013 Nov;80(5):642-649.e1. doi: 10.1016/j.wneu.2013.01.040. Epub 2013 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the effectiveness of two types of spinal cord stimulation programming types, in comparison to each other as well as patient baseline data.', 'detailedDescription': 'In this study patients have been implanted with an Abbott spinal cord stimulator capable of delivering both tonic (continuous) stimulation as well as Burst (intermittent) stimulation. Patients are programmed to be in both stimulation modes for a study period of 4 weeks, after which their pain symptoms are evaluated on a variety of surveys: McGill Pain Questionnaire (MPQ), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), Numerical Rating Scale (NRS) and Global Improvement. They also undergo Quantitative Sensory Testing (QST), where thermal, mechanical, vibration and pressure stimuli are applied to the patient and detection limits are documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Albany Medical Center neurosurgery patients with chronic leg and/or back pain, that have, or are going to have, spinal cord stimulator implantation.\n2. Patients are \\>/= 18 years old at the time of enrollment.\n3. Patients must be: fluent in English; mentally competent; able to read and answer questionnaires; complete pain assessments; and give informed consent.\n\nExclusion Criteria:\n\n1. Patients less than 18 years old.\n2. Patients unable or unwilling to: read and answer questionnaires; complete pain assessments; and give informed consent.'}, 'identificationModule': {'nctId': 'NCT04708392', 'briefTitle': 'Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients', 'organization': {'class': 'OTHER', 'fullName': 'Albany Medical College'}, 'officialTitle': 'Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients', 'orgStudyIdInfo': {'id': 'Burst 682552'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tonic spinal cord stimulation', 'description': 'Patients are programmed with tonic (continuous) spinal cord stimulation for a period of four weeks.', 'interventionNames': ['Device: Spinal Cord Stimulator']}, {'type': 'EXPERIMENTAL', 'label': 'Burst spinal cord stimulation', 'description': 'Patients are programmed with burst (intermittent) spinal cord stimulation for a period of four weeks.', 'interventionNames': ['Device: Spinal Cord Stimulator']}], 'interventions': [{'name': 'Spinal Cord Stimulator', 'type': 'DEVICE', 'description': "A spinal cord stimulator is a surgically implanted device that delivers an electrical signal to a patient's spinal cord to reduce the perception of pain", 'armGroupLabels': ['Burst spinal cord stimulation', 'Tonic spinal cord stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}], 'overallOfficials': [{'name': 'Julie Pilitsis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMC Department of Neurosurgery'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albany Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}