Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-03-05 @ 1:11 AM
Study NCT ID:
NCT03664206
Status:
WITHDRAWN
Last Update Posted:
2024-02-02
First Post:
2018-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Motor Neuron Disease Mechanisms by Threshold Tracking Transcranial Magnetic Stimulation and Magnetic Resonance Spectroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D049268', 'term': 'Positron-Emission Tomography'}], 'ancestors': [{'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The part on MRS could not be completed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2018-09-07', 'studyFirstSubmitQcDate': '2018-09-07', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'short interval intracortical inhibition (SICI) measured by threshold tracking TMS', 'timeFrame': '8 hours', 'description': 'Measurement of the relative change in resting motor threshold during different interstimulus intervals and stimulus intensities'}, {'measure': 'short interval intracortical inihibition (SICI) measured by conventional TMS', 'timeFrame': '8 hours', 'description': 'Measurement of the size of motor evoked potentials (MEP) during different interstimulus intervals and a predetermined stimulus intensity'}, {'measure': 'Concentration of GABA and glutamate', 'timeFrame': '1 hour', 'description': 'Concentration of GABA and glutamate quantified as a ratio of creatine or tissue water content'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treshold Tracking Transcranial Magnetic Stimulation', 'Magnetic Resonance Spectroscopy', 'Inter-rater agreement', 'Reproducibililty of Results', 'Case-control Studies', 'Biomarkers', 'Intra-rater agreement'], 'conditions': ['Amyotrophic Lateral Sclerosis', 'Motor Neuron Disease', 'Cortical Excitability']}, 'descriptionModule': {'briefSummary': 'Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which cases the death of neurons controlling the voluntary muscles. The death of motor neurons leads eventually to muscle weakness and muscle atrophy and as a consequence thereof, ALS patients die in average within three years after symptom onset due to respiratory failure.\n\nNo cure for ALS is currently known, and the medical diagnosis and clinical treatment are impeded by the lack of reliable diagnostic tools for objective disease assessment, and by the limited insight in disease pathophysiology since the underlying disease mechanisms still have not been fully elucidated.\n\nAn unbalance in the concentrations of GABA and glutamate, the most important inhibitory and excitatory brain metabolites, is suggested to play a role in the disease mechanisms of ALS. By applying Magnetic Resonance Spectroscopy (MRS), a magnetic resonance method which allows for quantification of brain metabolites, GABA and glutamate concentration can be quantified and thus hopefully elucidate their role in ALS disease mechanism.\n\nThreshold Tracking Transcranial Magnetic Stimulation (TT-TMS) studies carried out by a single research group have demonstrated cortical hyperexcitability (a physiology state in which neurons in the cerebral cortex are easier activated) as an early feature in ALS patients. For this reason, TT-TMS was suggested as a biomarker of ALS by the research group. However, to be able to suggest a test as a biomarker, one must show the test is reliable and reproducible.\n\nThe objectives of this study are therefore: to explore the pathophysiology of ALS by investigating the interaction between neuronal networks as assessed by TT-TMS and conventional TMS and MRS, and to investigate the reliability and reproducibility of TT-TMS. The aim is to examine the utility of TT-TMS and MRS as diagnostic tools for objective detection of ALS in the early disease stage.\n\nThe study will include 60 participants in total, subdivided into two groups: 30 healthy participants and 30 patients with clinical suspicion of motor neuron disease or ALS. Each participant will undergo examination with TMS and MRS, the primary outcomes will be compared between the two groups and the results from the TMS examinations and the MRS-scans will be correlated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited among patients examined at the Department of Neurophysiology who are referred for diagnostic neurophysiological examinations without any relation to the proposed project and at the Department of Neurology who are being examining for routine controls.\n\nThe healthy participants will be recruited by announcement at the homepage www.forsoegsperson.dk/ and by announcement at Aarhus University and Aarhus University Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with\n\n* possible, probable or definite ALS according to international criteria;\n* progressive muscular atrophy;\n* clinical suspicion of motor neuron disease or ALS\n\nHealthy participants: no younger than 45 years of age\n\nExclusion Criteria:\n\nPatients and healthy participants:\n\n* ealier central or peripheral nervous system disease\n* pacemaker or other implants\n* pregnancy\n* use of medications known to affect central nervous system'}, 'identificationModule': {'nctId': 'NCT03664206', 'briefTitle': 'Assessing Motor Neuron Disease Mechanisms by Threshold Tracking Transcranial Magnetic Stimulation and Magnetic Resonance Spectroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Assessing Motor Neuron Disease Pathophysiology by Two Novel Methods - Threshold Tracking Transcranial Magnetic Stimulation and Magnetic Resonance Spectroscopy', 'orgStudyIdInfo': {'id': 'AMND'}, 'secondaryIdInfos': [{'id': '7025-00066B', 'type': 'OTHER_GRANT', 'domain': 'Independent Research Fund Denmark'}, {'id': '18-2B-2454', 'type': 'OTHER_GRANT', 'domain': 'Aage og Johanne Louis-Hansens Fond'}, {'id': '17-L-0365', 'type': 'OTHER_GRANT', 'domain': 'The A.P. Møller Foundation'}, {'id': '3530', 'type': 'OTHER_GRANT', 'domain': 'Lundbeck Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'MRS, conventional TMS and treshold tracking TMS\n\nThe participants will be told not to consume coffee or alcohol or do exhausting exercise 12, 24 and 48 hours, respectively, prior to the examinations', 'interventionNames': ['Diagnostic Test: MRS, conventional TMS and treshold tracking TMS']}, {'label': 'Healthy subjects', 'description': 'MRS, conventional TMS and treshold tracking TMS\n\nThe participants will be told not to consume coffee or alcohol or do exhausting exercise 12, 24 and 48 hours, respectively, prior to the examinations', 'interventionNames': ['Diagnostic Test: MRS, conventional TMS and treshold tracking TMS']}], 'interventions': [{'name': 'MRS, conventional TMS and treshold tracking TMS', 'type': 'DIAGNOSTIC_TEST', 'description': 'Using\n\n* two MagStim 200 magnetic stimulator and a figure-of-eightc double 70 mm coil\n* SPECIAL MR Spectroscopy sequence\n\nIn addition, each group will undergo neurological examination', 'armGroupLabels': ['Healthy subjects', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Clinical Neurophysiology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Hatice Tankisi, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Clinical Neuropysiology, Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sándor Beniczky', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lundbeck Foundation', 'class': 'OTHER'}, {'name': 'Aage og Johanne Louis-Hansens Fond', 'class': 'OTHER'}, {'name': 'The A.P Moeller Foundation for Advancement of Medical Science', 'class': 'UNKNOWN'}, {'name': 'Danish Council for Independent Research', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Central Denmark Region', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sándor Beniczky', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}