Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:01 AM
Study NCT ID:
NCT07330466
Status:
RECRUITING
Last Update Posted:
2026-01-09
First Post:
2025-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Spinal Cord Stimulation Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-04', 'studyFirstSubmitDate': '2025-09-19', 'studyFirstSubmitQcDate': '2026-01-04', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' subjective pain intensity evaluated on a 0-10 Mechanical Visual Analogue Scale (M-VAS)", 'timeFrame': 'From enrollment to completion of four test sessions scheduled with a minimum interval of one week between each session.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal Cord Stimulation', 'Chronic pain'], 'conditions': ['Spinal Cord Stimulation']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate treatment outcomes of Spinal Cord Stimulation. In the study each patient participates in four test sessions of 4-5 hours. Patients arrive for test days with their stimulation on. In each test session, baseline pain is first evaluated. Then, SCS is regulated (on/off) and patients evaluate their pain intensity immidiately and every 15 minutes during the test sessions. Patients are blinded to the treatment conditions during their participation in the study. At all times, patients can resume their usual treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (\\>18 years of age) with SCS implanted to treat chronic pain.\n* Patients who consent to participation and can cooperate in the study.\n* Use of continuous paresthesia-free SCS for minimum 6 months prior to participation in the study.\n* Pain score of 7 or less on a 0-10 scale in the most painful area treated with SCS, rated upon inclusion.\n* Patients not receiving other neuromodulation treatment.\n* Patients who have not undergone changes in their (pain relevant) medication during the last 30 days (pro necessitate medication allowed).'}, 'identificationModule': {'nctId': 'NCT07330466', 'briefTitle': "Does Spinal Cord Stimulation Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects", 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': "Does Spinal Cord Stimulation (SCS) Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects", 'orgStudyIdInfo': {'id': 'Spinal Cord Stimulation'}, 'secondaryIdInfos': [{'id': '3165-00146B', 'type': 'OTHER_GRANT', 'domain': 'Independent Research Fund Denmark'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo condition', 'description': 'The patient is incorrectly told that stimulation is on', 'interventionNames': ['Device: Stimulation OFF', 'Device: Told ON']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Total treatment', 'description': 'The patient is correctly told that stimulation is on', 'interventionNames': ['Device: Stimulation ON', 'Device: Told ON']}, {'type': 'OTHER', 'label': 'Stimulation treatment', 'description': 'The patient is incorrectly told that stimulation is off', 'interventionNames': ['Device: Stimulation ON', 'Device: Told OFF']}, {'type': 'OTHER', 'label': 'Control condition', 'description': 'The patient is correctly told that stimulation is off', 'interventionNames': ['Device: Stimulation OFF', 'Device: Told OFF']}], 'interventions': [{'name': 'Stimulation ON', 'type': 'DEVICE', 'description': 'Stimulator will be turned on', 'armGroupLabels': ['Stimulation treatment', 'Total treatment']}, {'name': 'Stimulation OFF', 'type': 'DEVICE', 'description': 'Stimulation is turned off', 'armGroupLabels': ['Control condition', 'Placebo condition']}, {'name': 'Told ON', 'type': 'DEVICE', 'description': 'Verbal suggestion that stimulation is on', 'armGroupLabels': ['Placebo condition', 'Total treatment']}, {'name': 'Told OFF', 'type': 'DEVICE', 'description': 'Verbal suggestion that stimulation is off', 'armGroupLabels': ['Control condition', 'Stimulation treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Kaare Meier', 'role': 'CONTACT', 'email': 'kaare.meier@clin.au.dk', 'phone': '+45 24 99 50 34'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}], 'centralContacts': [{'name': 'Christina Emborg, Postdoc', 'role': 'CONTACT', 'email': 'chrisemb@psy.au.dk', 'phone': '+4520910215'}, {'name': 'Lene Vase, Professor', 'role': 'CONTACT', 'email': 'lenevase@psy.au.dk'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoc', 'investigatorFullName': 'Christina Emborg', 'investigatorAffiliation': 'University of Aarhus'}}}}