Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-28 @ 11:21 PM
Study NCT ID:
NCT06775535
Status:
RECRUITING
Last Update Posted:
2025-01-15
First Post:
2024-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2024-10-10', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with change in stimulation sensation', 'timeFrame': '6-months', 'description': 'Stimulation sensation will be characterized by study participants as better, worse or same for 5 different closed-loop sensitivity settings.'}], 'secondaryOutcomes': [{'measure': 'NRS', 'timeFrame': 'Baseline, 3-months, 6-months, 12-months post-implant', 'description': 'The numeric rating scale (NRS) is a pain screening tool. It is used to assess pain severity at that moment in time using a 0-10 scale. Zero meaning "no pain" and 10 meaning "the worst pain imaginable".'}, {'measure': 'Number of participants with reduced pain distribution', 'timeFrame': 'Baseline, 3-months, 6-months and 12-months post-implant', 'description': 'Pain distribution will be assessed by showing a visual representation of the body that enables participants to indicate the locations of their pain.'}, {'measure': 'Paraesthesia mapping', 'timeFrame': '3-months, 6-months and 12-months post-implant', 'description': 'Paraesthesia mapping will be assessed by showing a visual representation of the body that enables participants to indicate the locations where they feel paraesthesia.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Neuropathic Pain', 'Persistent Spinal Pain Syndrome Type 2']}, 'descriptionModule': {'briefSummary': 'Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.', 'detailedDescription': 'The study follow patients with chronic pain who received an EvokeTM spinal cord stimulator. The main aim of this study is to evaluate what influence different settings on nerve activation have and how this affects patients\\' sensation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects suffering from chronic pain and are eligible for SCS trial and permanent implant.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is deemed a suitable candidate for SCS trial and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.\n* Subject has a minimum of pain intensity of 5/10 on the numeric rating scale (NRS) at baseline\n* Subject is ≥ 18 years old.\n* Subject is not pregnant or nursing.\n* Subject is willing and capable of giving informed consent.\n\nExclusion Criteria:\n\n* Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system.\n* Subject is incapable of understanding or responding to the study questionnaires.\n* Subject is incapable of understanding or operating the patient programmer handset.'}, 'identificationModule': {'nctId': 'NCT06775535', 'acronym': 'NAA', 'briefTitle': 'Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'AZ Delta'}, 'officialTitle': 'Assessment of Neuronal Activation Accuracy and Stimulation Sensation in Patients with Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy', 'orgStudyIdInfo': {'id': '51773'}, 'secondaryIdInfos': [{'id': 'CME AZ Delta', 'type': 'OTHER', 'domain': '21083'}, {'id': 'Belgium registration number', 'type': 'OTHER', 'domain': 'B1172021000026'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ECAP-controlled, closed-loop SCS', 'type': 'DEVICE', 'description': 'Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8800', 'city': 'Roeselare', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'AZ Delta Hanssens', 'role': 'CONTACT', 'email': 'ctc.pijn@azdelta.be', 'phone': '0032 51 23 69 12'}, {'name': 'Karel Hanssens', 'role': 'CONTACT'}], 'facility': 'AZ Delta', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}], 'centralContacts': [{'name': 'Karel Hanssens, Dr.', 'role': 'CONTACT', 'email': 'ctc.pijn@azdelta.be', 'phone': '0032 51 23 69 12'}], 'overallOfficials': [{'name': 'Karel Hanssens', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AZ Delta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karel Hanssens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Karel Hanssens', 'investigatorAffiliation': 'AZ Delta'}}}}