Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-28 @ 4:51 PM
Study NCT ID:
NCT05885061
Status:
RECRUITING
Last Update Posted:
2023-06-12
First Post:
2023-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Spinal Cord Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013404', 'term': 'Suggestion'}], 'ancestors': [{'id': 'D006990', 'term': 'Hypnosis'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-08', 'studyFirstSubmitDate': '2023-05-01', 'studyFirstSubmitQcDate': '2023-05-22', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity, Visual Analogue Scale', 'timeFrame': 'Every 30 minutes during study session (max 5 hours)', 'description': '0-10 (0=no pain, 10=worst imaginable pain). Continual assessments to register changes.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional study is to test effects of spinal cord stimulation in patients receiving treatment for their chronic pain. The main question of the study is:\n\n• What is the effect of spinal cord stimulation when compared to placebo? Participants will rate their pain with their usual spinal cord stimulation on and off.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', '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': 'NCT05885061', 'briefTitle': 'Effects of Spinal Cord Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Effects of Spinal Cord Stimulation', 'orgStudyIdInfo': {'id': 'UAarhus_SCS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal cord stimulation turned on', 'interventionNames': ['Device: Spinal cord stimulation turned on (suggestions: off)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Spinal cord stimulation turned off', 'interventionNames': ['Device: Spinal cord stimulation turned off (suggestions: on)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal cord stimulation turned on and suggestions', 'interventionNames': ['Device: Spinal cord stimulation turned on with suggestions (suggestions on)']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Spinal cord stimulation turned on (suggestions: off)', 'type': 'DEVICE', 'description': 'Spinal cord stimulation turned on with verbal suggestions of treatment off', 'armGroupLabels': ['Spinal cord stimulation turned on']}, {'name': 'Spinal cord stimulation turned off (suggestions: on)', 'type': 'DEVICE', 'description': 'Spinal cord stimulation turned off with verbal suggestions of treatment on', 'armGroupLabels': ['Spinal cord stimulation turned off']}, {'name': 'Spinal cord stimulation turned on with suggestions (suggestions on)', 'type': 'DEVICE', 'description': 'Spinal cord stimulation turned on with verbal suggestions of treatment on', 'armGroupLabels': ['Spinal cord stimulation turned on and suggestions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lene Vase', 'role': 'CONTACT', 'email': 'lenevase@psy.au.dk'}, {'name': 'Sophie Rosenkjær', 'role': 'CONTACT', 'email': 'sr@psy.au.dk'}], 'facility': 'Department of Neurosurgery, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Lene Vase', 'role': 'CONTACT', 'email': 'lenevase@psy.au.dk', 'phone': '+4587165828'}, {'name': 'Sophie Rosenkjær', 'role': 'CONTACT', 'email': 'sr@psy.au.dk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}