Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-03-05 @ 3:31 AM
Study NCT ID:
NCT04934150
Status:
COMPLETED
Last Update Posted:
2021-07-01
First Post:
2021-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuronavigated Repetitive Transcranial Magnetic Stimulation (nrTMS) of the Dorsolateral Prefrontal and Primary Motor Cortex for the Treatment of Chronic Pain
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Sham stimulation was provided by turning the TMS coil to the non-stimulating side.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study was conducted in a single-blinded, randomized, placebo-controlled design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-28', 'studyFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Rating Scale', 'timeFrame': '36 weeks', 'description': '0-10 0 = no pain, 10 = worst pain'}], 'secondaryOutcomes': [{'measure': 'Self-reported "Depression, Anxiety and Stress Scale" (DASS) questionnaire.', 'timeFrame': '36 weeks', 'description': '0- 21 for each item, higher scores indicate worse symptoms. Lower scores indicate a better outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This study investigated the effects of navigated repetitive Transcranial Magnetic Stimulation on nociception and quality of life in patients suffering from chronic pain conditions. Two cortical targets (dorsolateral prefrontal cortex/DLPFC and M1 area) were stimulated and compared to Sham stimulation.', 'detailedDescription': 'From 34 patients, 24 completed the study. The M1-area was stimulated with 10 Hz rTMS while the DLPFC received a 5Hz stimulation. In total, 13 session were administered over a period of 36 weeks with most frequent stimulation in the first 4 weeks of the trial. Results were compared to Sham-TMS over the M1 area at the same schedule than the actual therapy. Outcome parameters included the German Pain Questionnaire (GPQ), the Depression, Anxiety and Stress Scale" (DASS) and quality of life (QoL) with the SF-12 questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 80 years\n* clinical diagnosis of chronic LBP (low back pain) and or neck pain\n* average resting pain-level \\> than 3 in the Numeric Rating Scale (0-10)\n* no changes in pain medication 4 weeks at baseline\n* no surgical procedures in the last 2 years\n\nExclusion Criteria:\n\n* metallic and electronic implants in the head, neck and chest\n* medication e.g. tetracyclic antidepressants, antiviral, antipsychotic, opioid doses \\> 100mg orally/d\n* history of frequent headache or tinnitus\n* alcohol or drug abuse\n* pregnant patients\n* breastfeeding patients'}, 'identificationModule': {'nctId': 'NCT04934150', 'briefTitle': 'Neuronavigated Repetitive Transcranial Magnetic Stimulation (nrTMS) of the Dorsolateral Prefrontal and Primary Motor Cortex for the Treatment of Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Neuronavigated Repetitive Transcranial Magnetic Stimulation (nrTMS) of the Dorsolateral Prefrontal and Primary Motor Cor-tex for the Treatment of Chronic Pain: a Randomized Place-bo-controlled Trial', 'orgStudyIdInfo': {'id': '30-459-ex 17/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'M1 stimulation', 'description': '10 Hz stimulation of left motor area', 'interventionNames': ['Device: navigated repetitive Transcranial Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DLPFC stimulation', 'description': '5 Hz stimulation of left dorsolateral prefrontal cortex', 'interventionNames': ['Device: navigated repetitive Transcranial Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham TMS', 'description': 'Sham TMS over the left M1 area', 'interventionNames': ['Device: navigated repetitive Transcranial Stimulation']}], 'interventions': [{'name': 'navigated repetitive Transcranial Stimulation', 'type': 'DEVICE', 'description': 'High frequency nrTMS over 13 sessions (1800-2000 pulses per session) over DLPFC and M1 cortical areas.', 'armGroupLabels': ['DLPFC stimulation', 'M1 stimulation', 'Sham TMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medical University Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}