Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-26 @ 4:52 PM
Study NCT ID:
NCT05596058
Status:
TERMINATED
Last Update Posted:
2024-02-01
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-pharmacological Treatments in Migraine.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients do not know other type of intervention; who have to do the assessment do not know the type of interventions'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We are going to use a simple randomization scheme 1:1:1 with excel and assign subjects into three groups respectively: 15 patients in physical-cognitive tasks groups, 15 patients in active exercise Only and 15 patients in Cognitive training.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Due to the unavailability of the subjects who gave the consent to participate to the study protocol', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-10-22', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Neuropsychological tests', 'timeFrame': 'Before each treatment', 'description': 'Frontal assessment battery'}, {'measure': 'Neuropsychological tests', 'timeFrame': '3 months of each treatment', 'description': 'Frontal assessment battery'}, {'measure': 'Neuropsychological tests', 'timeFrame': '4 months', 'description': 'Frontal assessment battery'}, {'measure': 'Neuropsychological tests', 'timeFrame': 'Before each treatment', 'description': 'Trail Making Test'}], 'primaryOutcomes': [{'measure': 'Values of Transcranial magnetic stimulation in migraine patients', 'timeFrame': 'Before each treatment', 'description': 'Rest motor threshold in mV'}, {'measure': 'Change from Baseline of the values of Transcranial magnetic stimulation in migraine patients at 3 months', 'timeFrame': '3 months', 'description': 'Rest motor threshold in mV'}, {'measure': 'Change from baseline of the value of Transcranial magnetic stimulation in migraine patients at 4 months', 'timeFrame': '4 months', 'description': 'Rest motor threshold mV'}], 'secondaryOutcomes': [{'measure': 'Headache parameters and MIDAS', 'timeFrame': 'Before each treatment', 'description': 'migraine days per month assessed with diary'}, {'measure': 'Headache parameters and MIDAS', 'timeFrame': '3 months of each treatment', 'description': 'Change from baseline of migraine days per month assessed with diary at 3 months'}, {'measure': 'Headache parameters and MIDAS', 'timeFrame': '4 months', 'description': 'Change migraine days per month assessed with diary at 4 months'}, {'measure': 'Algometer Assessment', 'timeFrame': 'Before each treatment', 'description': 'Change pressure pain threshold in 6 muscles'}, {'measure': 'Algometer Assessment', 'timeFrame': '3 months of each treatment', 'description': 'change pressure pain threshold in 6 muscles'}, {'measure': 'Algometer Assessment', 'timeFrame': '4 months', 'description': 'change pressure pain threshold in 6 muscles'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine', 'Habituation', 'Sensitization', 'transcranial Magnetic stimulation'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'Migraine may have an adverse effect on physical, cognitive, and psychosocial functioning. It causes major consequences for the quality of life of the sufferer and a major burden on the health care system.\n\nAbout the physiopathology, two opposing processes, depression (habituation) and facilitation (sensitization), determine the final behavioural outcome after a sequence of repetitive stimuli.\n\nSensitization is a general behavioural response of augmentation to innocuous sensory and noxious stimuli. It has been associated with a dysfunction in descending pain inhibition.\n\nThe nature or intensity of a painful event does not strongly relate to the development of chronic pain, but an individual\'s behavioural response to the event contributes to chronicity. Imaging data have identified that chronic pain may change the structure of the brain in response to environmental demands.\n\nIt suggests that the brain of healthy control has a "healthy response" to frequent nociceptive input, such as "habituation", while chronic pain patients show a "maladaptive plasticity".\n\nHabituation is "a response decrement as a result of repeated stimulation". It is a phenomenon observed in the autonomic and behavioural component called the "orienting response" in humans. The orienting response is elicited when a novel stimulus is encountered, and it directs attention toward that stimulus. When the same stimulus is presented repeatedly occur habituation. Researchers have found a number of physiological mechanisms associated with Orienting response. Habituation of the orienting response is a simple form of learning and acts an attentional filtering mechanism that makes people able to select what is part of their present goal and adapt to environment. In this way only one channel of information to be processed, with the rest filtered out. Habituation depends on a memory process whereby the organism learns to associate goal irrelevant stimuli with a no-consequence response.\n\nLack of Habituation during stimulus repetition is a functional property of the brain in people with migraine between attacks. Thalamo-cortical dysrhythmia and lack of H characterize migraineurs\' brains. This abnormal information processing increases during the pain-free days, the vertex is just before the attack, and decreases in the ictal phase. Migraineurs are characterized by a generally increased sensitivity to visual (sensitivity to light), auditory (to sound), or somatic stimuli not only during the attack, but also outside of the attack.\n\nIt was confirmed also by analysing motor cortex excitability. Aerobic exercises may be effective as pharmacological treatment in the management of migraine and focused attention task may help human subjects to better ignore irrelevant stimuli.\n\nThe main aim of this study is to assess the efficacy of a non-pharmacological treatment, such as physical therapy, with a specific dual task protocol of active exercise with concomitant cognitive tasks, in relation to habituation (Transcranial magnetic stimulation) and sensitization (Algometer assessment) neurophysiological outcomes. The second aim is to assess these non-pharmacological treatments concerning to clinical outcomes (intensity of pain, duration of attacks and frequency of pain; neurophysiological test on executive functions).', 'detailedDescription': "A Randomized Controlled Trial (RCT) will be conducted on three groups of patients with migraine. The project was approved by the institutional review board C.E.U.R. . Patients will be recruited and randomized by the Neurologic Clinic, Headache Centre (University of Trieste in the Department of Medical, Surgical, and Health Sciences), diagnosing Migraine after a neurologic visit (diagnostic criteria of ICDH3-beta).\n\nIn the first enrollment visit (T0), the patients will be undergone anamnestic evaluation, neurological and general objective examination. The following criteria of exclusion are going to be respected: pregnancy; serious psychiatric pathologies, serious pathologies as traumas, cancers or infective pathologies, important surgery procedures during the last year; physiotherapy and other no pharmacological treatment for another pathology; less than 18 years of age; presence of multiple migraine; presence of therapeutics changes linked to headache in the last 3 months; absence of pharmacological prophylaxis treatment in the last 3 months; no auditory or visual processing disorders. While, the criteria of inclusion are going to be the following: diagnosis migraine (diagnostic criteria of ICDH3-beta); Age over 18. Patients are going to be given a diary for cephalic outcome: frequency (headache days a month), intensity and duration of attack. The paper diary is going to inserted into a specific database for subsequent data analysis.\n\nAll patients are going to re-evaluated with the diary after one month (T1). The frequency is going to be between 15 days a month and 18 days a month. Transcranial magnetic Stimulation is going to be recorded.The Migraine disability assessment scale (MIDAS) will be performed. The MIDAS questionnaire consist of five questions aimed at assessing the impact of migraine on the patients' daily life in the 3 months prior to the study, in terms of absence from work or school, inability to carry out household chores, or take part in family, social, or leisure activities expressed in days. The final score was obtained by adding up the total number of days for each of the five questions.\n\nSimple randomization scheme 1:1:1 was used with excel and assign subjects into three groups respectively: 15 patients in physical-cognitive tasks groups, 15 patients in active exercise Only and 15 patients in Cognitive task only. All patient going to sign the informed consent.\n\nPatients will be allowed to take symptomatic medications in case of severe headache according to guidelines of the International Headache Society. Patients will be only asked to limit symptomatic medications consumption for a maximum twice per week in order to not affect the interpretation of data. Finally, after three months of treatment, the final visit will be performed (T2) with clinical re-evaluation of the patients and analysis of the cephalic parameters reported in the diary, the data of transcranial magnetic stimulation and the headache-related disability with MIDAS.\n\nAll patients will be reexamined at 1 months follow up (T3) with the diary, Transcranial magnetic stimulation and MIDAS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis migraine (diagnostic criteria of ICDH3-beta)\n* Age over 18\n\nExclusion Criteria:\n\n* pregnancy\n* serious psychiatric pathologies\n* serious pathologies as traumas, cancers or infective pathologies\n* important surgery procedures during the last year\n* physiotherapy and other no pharmacological treatment for another pathology\n* less than 18 years of age;\n* presence of multiple migraine\n* presence of therapeutics changes linked to headache in the last 3 months\n* absence of pharmacological prophylaxis treatment in the last 3 months\n* no auditory or visual processing disorders'}, 'identificationModule': {'nctId': 'NCT05596058', 'briefTitle': 'Non-pharmacological Treatments in Migraine.', 'organization': {'class': 'OTHER', 'fullName': 'University of Trieste'}, 'officialTitle': 'Efficacy of a Non-pharmacological Treatments on Neurophysiological and Clinical Outcomes', 'orgStudyIdInfo': {'id': '080_2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dual task (active exercise and cognitive task)', 'description': 'The dual task protocol is going to be in 15 one-hour sessions once a week in the headache free days.\n\nThis protocol will be set up in the clinic of physiotherapy degree (University of Trieste in the Department of Medical, Surgical, and Health Sciences).\n\nThe physical training tasks will be associated with concomitant cognitive tasks specifically relying on executive function.\n\nThe goal is to engage the three core executive functions: inhibition (the ability to inhibit automated responses), working memory (the ability to hold, process, and manipulate information in mind) and shifting (the ability to change stimulus-response associations for performing an ongoing task).\n\nPatients will be exposed to different cognitive tasks during physical activity such as walking or running on the treadmill, indoor cycling and balance exercises.\n\n\\-', 'interventionNames': ['Other: dual task protocol: active exercises with concomitant cognitive training in executive functions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'active exercise only', 'description': 'The active exercise only intervention is going to consist of aerobic and flexibility training with a targeted duration of 1 hour, twice per week for 3 months.', 'interventionNames': ['Other: active exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive task trainig only', 'description': 'The Cognitive task training only engage the three core executive functions: inhibition (the ability to inhibit automated responses), working memory (the ability to hold, process, and manipulate information in mind) and shifting (the ability to change stimulus-response associations for performing an ongoing task).', 'interventionNames': ['Other: cognitive task only']}], 'interventions': [{'name': 'dual task protocol: active exercises with concomitant cognitive training in executive functions', 'type': 'OTHER', 'description': 'The active exercise tasks will be associated with concomitant cognitive tasks specifically relying on executive function.\n\nThe goal is to engage the three core executive functions: inhibition (the ability to inhibit automated responses), working memory (the ability to hold, process, and manipulate information in mind) and shifting (the ability to change stimulus-response associations for performing an ongoing task).\n\nPatients will be exposed to different cognitive tasks during physical activity such as walking or running on the treadmill, indoor cycling and balance exercises.', 'armGroupLabels': ['Dual task (active exercise and cognitive task)']}, {'name': 'active exercise', 'type': 'OTHER', 'description': 'Physical activity and motor task only', 'armGroupLabels': ['active exercise only']}, {'name': 'cognitive task only', 'type': 'OTHER', 'description': 'cognitive exercise in executive functions', 'armGroupLabels': ['Cognitive task trainig only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34148', 'city': 'Trieste', 'state': 'TS', 'country': 'Italy', 'facility': 'Manuela Deodato', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Trieste', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Manuela Deodato', 'investigatorAffiliation': 'University of Trieste'}}}}