Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT01554332
Status:
UNKNOWN
Last Update Posted:
2020-06-12
First Post:
2012-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Cortex Stimulation for Chronic Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D005157', 'term': 'Facial Pain'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2012-01-13', 'studyFirstSubmitQcDate': '2012-03-12', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Approximately 7 months', 'description': 'The primary analysis of effectiveness is based on the mean differences in changes from the period-specific baseline in VAS scores when patients are receiving 3 month of active vs. 3 months of sham stimulation on a double-blinded fashion.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale, responder', 'timeFrame': 'Participants will be followed for approximatley 18 months', 'description': 'defined as a ≥30% or 2 points reduction from baseline in VAS scores'}, {'measure': 'Neuropathic Pain Symptom Inventory (NPSI)', 'timeFrame': 'Participants will be followed for approximatley 18 months'}, {'measure': 'Brief Pain Inventory (BPI)', 'timeFrame': 'Participants will be followed for approximatley 18 months'}, {'measure': 'Short Form of the McGill Pain Questionnaire(SF-MPQ)', 'timeFrame': 'Participants will be followed for approximatley 18 months'}, {'measure': 'Sickness Impact Profile (SIP)', 'timeFrame': 'Participants will be followed for approximatley 18 months'}, {'measure': 'Medication Quantification Scale (MQS)', 'timeFrame': 'Participants will be followed for approximatley 18 months'}, {'measure': 'SF-36 Health Survey and safety', 'timeFrame': 'Participants will be followed for approximatley 18 months'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Participants will be followed for approximatley 18 months'}, {'measure': "Global Impression of Change (patient and evaluator's version)", 'timeFrame': 'Participants will be followed for approximatley 18 months'}, {'measure': 'Device related Adverse Events', 'timeFrame': 'Participants will be followed for approximatley 18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Motor Cortex Stimulation', 'Neuropathic pain'], 'conditions': ['Neuropathic Pain', 'Facial Pain', 'Post-stroke Pain', 'Brachial Plexus Avulsion', 'Phantom Limb Pain of the Upper Extremities']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of cortical stimulation (CS) as an adjunctive treatment for chronic neuropathic pain.', 'detailedDescription': 'Prospective, controlled, double blind, randomized, crossover study with endpoint evaluations at the end of each 3-month treatment period.\n\nAn interim analysis will be conducted by a blinded committee when approximately half of the patients have finished the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women (non-pregnant) age 21-70 years;\n* Able to give informed consent in accordance with institutional policies;\n* Diagnosis of chronic neuropathic pain according to the DN4 Neuropathic Pain Diagnosis scale (score ≥ 4).\n* Documented pain for at least 12 months;\n* Documented previous or current treatment for neuropathic pain with medications from at least two of the following groups at adequate doses: antidepressants, anticonvulsants, and/or gabapentinoids;\n* VAS scores of at least 6 during baselines #1 and 2.\n* Documented clinical diagnosis of neuropathic pain associated with one of the following conditions: facial pain, post-stroke pain, brachial plexus avulsion, or phantom limb pain of the upper extremities.\n* In the group with post-stroke pain, only patients with predominant face and upper extremity pain will be included. This will be defined as a difference of ≥ 30% or ≥ 2 points in VAS scores between these regions and lower extremity (in patients who also have pain in the leg).\n* No change in current neuropathic pain medication regimen for at least 4 weeks prior to study enrollment.\n* Able to comply with all testing and follow-up requirements as defined by the study protocol.\n* Must be determined medically stable by surgeon to undergo cortical stimulation surgical procedure.\n\nExclusion Criteria:\n\n* Alcohol, medication, or illegal substance dependence or abuse within last 12 months;\n* Trigeminal neuralgia or atypical facial pain.\n* Post-stroke pain predominantly in the lower extremity.\n* Advanced cardiovascular disease which renders anesthesia and surgery as unsafe as determined by neurosurgeon;\n* Clinically relevant abnormality (e.g. tumor) on study MRI;\n* Has cardiac pacemaker/defibrillator or other implanted active stimulator;\n* Has a medical condition requiring a repetitive MRI body scan;\n* Requires chemotherapy for the treatment of malignancy or requiring chronic oral or intravenous, immunosuppressive, or steroid therapy;\n* Is unable to comply with study visit schedule and timeline;\n* Past ablative or relevant intracranial surgery;\n* A female lactating or of child bearing potential, with a positive pregnancy test or not using adequate contraception;\n* Other medical conditions likely to require hospitalization within the next year.'}, 'identificationModule': {'nctId': 'NCT01554332', 'briefTitle': 'Motor Cortex Stimulation for Chronic Neuropathic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'A Clinical Evaluation for the Management of Patients With Chronic Neuropathic Pain With Cortical Stimulation', 'orgStudyIdInfo': {'id': 'C-11-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active stimulation', 'interventionNames': ['Device: Motor Cortex Stimulation using SJM EonC Stimulator']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham stimulation', 'interventionNames': ['Device: Motor Cortex Stimulation using SJM EonC Stimulator']}], 'interventions': [{'name': 'Motor Cortex Stimulation using SJM EonC Stimulator', 'type': 'DEVICE', 'description': 'Patients will be randomized to receive either active stimulation the first 3 months followed by a one-month washout, followed by Sham Stimulation the next 3 months, vs. the reverse order of treatment, followed by single blind stimulation, and an open label phase.', 'armGroupLabels': ['Active stimulation', 'Sham stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'University of São Paulo - Hospital das Clínicas', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Edward Karst', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Neuromodulation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}