Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT06356805
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2024-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
rTMS Effect on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], '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'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-03-31', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1- Assessment of Fibromyalgia Impact Questionnaire (FIQ)', 'timeFrame': '3 months', 'description': 'Assessment of the changes (pre-post one month and pre- post three months later) in Fibromyalgia Impact Questionnaire FIQ. It is a brief 10-item self-administered instrument that takes approximately 5 minutes to complete. It has been designed to measure physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and wellbeing. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.'}], 'secondaryOutcomes': [{'measure': '1-Assessment of Hamilton depression (HDRS) and Hamilton Anxiety scales (HARS) (pre- post sessions and pre post three months)', 'timeFrame': '3 months follow up', 'description': 'Assessment of the changes (pre-post one month and pre- post three months later) of HDRS and HARS in Fibromyalgia patients. It contains 17 items (HDRS) pertaining to symptoms of depression experienced over the past week. The HARS consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety and somatic anxiety (physical complaints related to anxiety).'}, {'measure': 'Assessment of different cognitive rating scales (Montreal cognitive Assessment scale (MoCa), and Rey Auditory Verbal Learning Test [RAVLT],', 'timeFrame': '3 months follow up', 'description': 'Assessment the changes of different cognitive rating scales (pre-post sessions and pre- post three months later) in fibromyalgia patients.\n\nMoCa takes 10 to 12 minutes to complete. It based on 11 questions that evaluate seven domains of cognitive function. The MoCa has a maximum score of 30, and anything below 24 is a sign of cognitive impairment.\n\nRAVLT: it consists of five presentations of a 15-word list are given, each followed by attempted recall. This is followed by a second 15-word interference list (list B), followed by recall of list A. The number of correct words summed for the Total Recall score (range = 0-75). The Delayed Recall score is the number of correct words recalled after a 30-min delay (range = 0-15).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rTMS', 'FIBROMYALGIA', 'Hamilton depression and Anxiety scale', 'MoCa', 'DLPFC'], 'conditions': ['Treatment Resistant Disorders']}, 'descriptionModule': {'briefSummary': 'the aim of this work was to evaluate the effect of low frequency rTMS over the right dorsolateral prefrontal area (DLPFC) on Fibromyalgia patients. Fibromyalgia Impact Questionnaire (FIQ), Hamilton depression and Anxiety scale and different cognitive rating scales were evaluated pre-1 month post sessions and pre -post 3 months later. all eligible patients with fibromyalgia (FM) were randomized to have 20 sessions of active or sham rTMS over right DLPFC. The improvement changes in groups were compared in each rating scale.', 'detailedDescription': 'The present study was aimed to evaluate the effect of low frequency rTMS over the right dorsolateral prefrontal area (DLPFC) on Fibromyalgia patients. recruitment of the patients were consecutively. Impact Questionnaire (FIQ), psychiatric and cognitive scales were evaluated before rTMS. 42 eligible patients with fibromyalgia (FM) were randomly assigned to one of two groups with equal ratio. each patient received 20 sessions of active or sham rTMS (1 Hz, 120% of resting motor threshold with total 1200 pules /session) over right DLPFC. follow up of each patient was done blindly at , one and 3 months later with the same rating scales (FIQ, Hamilton depression and anxiety Rating Scales (HDRS and HARS), Montreal Cognitive Assessment (MoCA), Rey Auditory Verbal Learning Test (RAVLT), Tower of London test (TOL), the Trail Making and Digit Span Tests). comparison between the changes in different rating scales were done at 1- and 3-months follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe diagnosis of fibromyalgia was made according to American College of Rheumatology criteria with age at and older than 18 years\n\nExclusion Criteria:\n\nInflammatory rheumatic disease, auto immune disease, or other painful disorders. Any uncontrolled clinical disease (such as thyroid, cardiovascular, pulmonary, hematological, or renal disease) that affects cognition. Pregnancy, lactation. patients have one of Contra-indications for rTMS (a history of seizures, brain trauma, brain surgery or intracranial hypertension, a pacemaker, or other metallic implants), Past history of other neurological disorders (neurodegenerative diseases, dementia), or primary psychiatric disorders (psychosis, or major depression (17-item Hamilton Depression Rating Scale \\> 23), or drug treatments that affect cognition. Inability to cooperate with the questionnaire survey or the patient refuses to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06356805', 'acronym': 'rTMS', 'briefTitle': 'rTMS Effect on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia: A Double Blinded, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'rTMS in Fibromyalgia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active rTMS', 'description': 'Active rTMS of 1 Hz at an intensity of 120% RMT for 60 seconds(20 Trains), with a 45-second gap between trains giving a total of 1,200 pulses/day with the center of coil over rt DLPFC (5cm anterior to hand area). Five sessions/week for 4 consecutive weeks were applied', 'interventionNames': ['Device: repetitive transcranial magnetic stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham rTMS', 'description': 'Sham rTMS of 1 Hz at an intensity of 120% RMT for 60 seconds (20 Trains), with a 45-second gap between trains giving a total of 1,200 pulses/day with the coil held perpendicular to the rt DLPFC (5cm anterior to hand area). Five sessions/week for 4 consecutive weeks were applied.', 'interventionNames': ['Device: repetitive transcranial magnetic stimulation']}], 'interventions': [{'name': 'repetitive transcranial magnetic stimulation', 'type': 'DEVICE', 'description': 'Parallel study: Participants are assigned to one of two groups in parallel for 3 months follow up', 'armGroupLabels': ['Active rTMS', 'Sham rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11517', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Eman Khedr', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Eman Khedr, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanta University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of neurology/Faculty of medicine, Assiut University', 'investigatorFullName': 'Eman M. Khedr', 'investigatorAffiliation': 'Assiut University'}}}}