Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-14 @ 5:47 AM
Study NCT ID:
NCT03084094
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2017-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromodulation and Its Therapeutic Potentiality in Different Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-04', 'studyFirstSubmitDate': '2017-03-07', 'studyFirstSubmitQcDate': '2017-03-13', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Pain at 2 weeks', 'timeFrame': '1 week prior to treatment (Baseline) and 1 week during treatment', 'description': 'Diary of Pain'}, {'measure': 'Change from Baseline Pain at 5 weeks', 'timeFrame': '1 week prior to treatment, day 1 of treatment, last day of treatment (day 5), 7 days, 14 days and 21 days after treatment', 'description': 'Pressure Pain Threshold and Tolerance by an algometer'}, {'measure': 'Change from Baseline Pain at 5 weeks', 'timeFrame': '1 week prior to treatment, day 1 of treatment, last day of treatment (day 5), 7 days, 14 days and 21 days after treatment', 'description': 'Visual Analogue Scale'}], 'secondaryOutcomes': [{'measure': 'Functional Capacity', 'timeFrame': '1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment', 'description': 'Fibromyalgia Impact Questionnaire'}, {'measure': 'Mood', 'timeFrame': '1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment', 'description': 'Beck Depression Inventory'}, {'measure': 'Anxiety', 'timeFrame': '1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment', 'description': 'Hamilton Anxiety Scale'}, {'measure': 'Positive and negative affect', 'timeFrame': '1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment', 'description': 'Positive and Negative Affect Schedule'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'tDCS'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'One of the big challenges faced by researchers who act in rehabilitation science is the capacity to dispose integrative approaches for its utilization in clinical practice. The border profile of a physiotherapy researcher is to be in front of applied research amplification in experimental integrative approaches, involving the study of behavioral and physiological variables.\n\nThe rehabilitation process transcends the systems physiology and encompasses the cognitive behavioral feature of being adapted to the environment that surround us. It is now known by the scientific rehabilitation community the necessity for evidence based therapies and even more, therapeutic innovation. In both conditions, of health and illness, various options to use integrative approaches are today available in physiotherapy, including behavioral and physiological profiles of the individuals during physical activities, response to stress and in the field of chronic pain.\n\nIt is in the clinical routine of numerous rehabilitation centers the treatment of diseases that causes pain, being the leading figure in a physiotherapist work process. The innovative study of resources that can alter the pain state of this patients becomes primordial for routine clinical use, low cost and easy to apply. The therapeutic treatment for pain offered by a physiotherapist need new investigative options based in evidences from the association between the neuronal, behavioral and physiological responses where the brain is the central organ of this regulation. In this context, become increasingly more necessary the construction of investigative approaches in the purpose of reaching the clinical practice, in a reduced time lapse, once the great volume of information produced globally does not impact in short or medium term in new therapeutic recommendations.\n\nAmong the various chronic painful entities, it is presented the fibromyalgia (FM), painful diabetic polyneuropathy and primary dysmenorrhea because of its painful pathogenic complexity and its limited therapeutic against pain in rehabilitation process. The 3 painful entities presents the central nervous system as main participant of neurogenesis and maintenance of the painful state.\n\nIt is primordial importance that rehabilitation science improve methods of non invasive brain neuromodulation that allows, through excitation or inhibition of specific cortical areas in order to produce pain inhibition, providing a simple and low cost treatment to clinical routine. Technological advances and non invasive techniques to modulate brain function has been developed, among which transcranial direct current stimulation (tDCS) stands out. Basically, electrodes are placed in targeted brain regions that you want to stimulate or inhibit. Posteriorly, is applied a continuous electric current (0,4 - 2 mA) for a 3-20 minutes period, in order to modify cortical excitability. The stimulus of the anodic current increases cortical excitability whereas the stimulus of the cathodic current has an inhibitory effect.\n\nFew are the research groups that address the issue of fibromyalgia, painful diabetic polyneuropathy and primary dysmenorrhea and the application of tDCS as research focus, being a border area for rehabilitation science and great potential in clinical use. Preliminary studies associates the use of tDCS with the decrease of painful state, however an approach of physical function and behavioral results needs greater investigation.\n\nThe purpose of the presented project is to present the tDCS as a new modality in physical rehabilitation for the patient with chronic pain of the 3 entities mentioned above. The study proposal is to present behavioral, social and physical results of tDCS application in this patients, suggesting a better quality of life and functionality of the individual.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Female gender aged from 18 to 65 year old, having a clinical diagnosis of Fibromyalgia given by a rheumatologist.\n\nExclusion Criteria:\n\n* Non-regulated psychiatric disorders (bipolar, main depression, schizophrenia)\n* Performing other types of treatment during the research\n* Performing physical activities'}, 'identificationModule': {'nctId': 'NCT03084094', 'briefTitle': 'Neuromodulation and Its Therapeutic Potentiality in Different Populations', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio Grande do Norte'}, 'officialTitle': 'Transcranial Direct Current Stimulation and Its Therapeutic Potentiality in Different Populations', 'orgStudyIdInfo': {'id': 'tDCS in fibromyalgia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'M1', 'description': 'Transcranial direct current Stimulation in primary motor cortex', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'DLPFC', 'description': 'Transcranial direct current Stimulation in the dorsolateral pre-frontal cortex', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'sham stimulation', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}], 'interventions': [{'name': 'Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'description': 'Non invasive brain modulation at a 2mA current during 20minutes', 'armGroupLabels': ['DLPFC', 'M1', 'Sham']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Natal', 'state': 'Rio Grande do Norte', 'country': 'Brazil', 'facility': 'Hospital Universitário Onofre Lopes', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio Grande do Norte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karime Andrade Mescouto', 'investigatorAffiliation': 'Universidade Federal do Rio Grande do Norte'}}}}