Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT02226432
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-19
First Post:
2014-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Antagonistic Muscle Magnetic Stimulation and Selective Periferal Neurotomy to Improve Results on Spasticity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2014-08-16', 'studyFirstSubmitQcDate': '2014-08-26', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': 'Post operative Modified Ashworth Scale /MAS) setted up monthly for each patient taking into account the postoperative date, during six continued months.', 'description': '\\- Mean Preoperative and sequencial monthly postoperative evaluation of stiffness and ranges of joint pasive movements at the shoulder, elbow, wrist and fingers.'}], 'secondaryOutcomes': [{'measure': 'Fugl - Meyer Scale', 'timeFrame': 'Post operative Fugl - Meyer Scale evaluation, setted up monthly for each patient taking into account the postoperative date, during six continued months.', 'description': 'Pre and post operative evaluation of a set of active and pasive movements and articular angles in the upper limb'}, {'measure': 'Barthel Scale', 'timeFrame': 'Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months.', 'description': 'Pre and post operative evaluation of ten basic current dayly life activities, scored 10, 5 or 0 points each one, a total of 100 points'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Barthel Scale', 'Disability', 'Modified Ashworth Scale', 'Right Arm', 'Neuromodulation', 'Spasticity', 'Stroke'], 'conditions': ['STROKE']}, 'descriptionModule': {'briefSummary': "The objective of the present trial is to demonstrate Magnetic stimulation as an useful complementary treatment in order to improve patients' evolution without the need of extensive surgical lesion.", 'detailedDescription': "Patients with refractory post stroke upper right limb spasticity will operated by Median nerve or Median/ Cubital selective neurotomy depending upon more affected territories.\n\nSome of them could be also also operated with posterioris tibialis neurotomy to treat equine's foot whenever also clinically present. Preoperative motor blocks might be possitive in all cases.\n\nA week later, they will be treated by magnetic stimulation on selected antagonistic muscles, related to pre - operative affected ones, mostly deltoids, triceps and finger extensors with an equipment Dipol Zeta D5 (Russian Federation), with 1.5 tesla of intensity.\n\nTrials will be repeated twice a week in sessions of 30 minutes during 6 months with simultaneous intensive classic rehabilitation.\n\nPatients will be monthly evaluated by the mean score of Modified Ashworth Scale, related to fingers, wrist, elbow and shoulder and also with Barthel Scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe and refractory right Hemiparesia or Hemiplegia, affecting hand function.\n* Failure of kinesic treatment\n* 2 points or more Improvement on Modified Ashworth Scale after anestethic blockade\n\nExclusion Criteria:\n\n* Severe cardiovascular disease\n* Severe pulmonary disease\n* Neoplasia advanced disease\n* Joint anchylosis\n* Irreversible retraction for muscle fibrosis'}, 'identificationModule': {'nctId': 'NCT02226432', 'acronym': 'Andreani2', 'briefTitle': 'Combined Antagonistic Muscle Magnetic Stimulation and Selective Periferal Neurotomy to Improve Results on Spasticity', 'organization': {'class': 'OTHER', 'fullName': 'Sociedad Argenttina de Neuromodulación'}, 'officialTitle': 'The Use of Antagonistic Muscle Magnetic Stimulation to Avoid Extensive Lesions and Improve Results of Selective Peripheral Neurotomy on Refractory and I POost Stroke Spasticity With Exclusive or Predominant Right Upper Limb Arm', 'orgStudyIdInfo': {'id': 'Andreani, JCM 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Kinesics', 'description': '\\- Classic Rehabilitation and Kinesic Therapy', 'interventionNames': ['Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation', 'Other: Kinesics']}, {'type': 'SHAM_COMPARATOR', 'label': 'surgery', 'description': '\\- Surgery:\n\nSelective Peripheral Neurotomy is surgical a method of section on suplying peripheral nerves of motor fascicles to relieve harmful spasticity. An intraoperative stimulation of motor fascicles is done, and those which abnormal spreading on far placed myotomes are more evident are chosen to be sectioned.', 'interventionNames': ['Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation', 'Other: Kinesics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Magnetic Stimulation', 'description': '\\- Postoperative Antagonistic Peripheral Magnetic Stimulation with 1.5 tesla intensity, infrathreshold 80 per cent of minimal intensity able to produce always muscle contraccion. Trials repeated twice a week in sessions of 30 minutes during 6 months', 'interventionNames': ['Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation', 'Device: Selective Peripheral Magnetic Stimulation', 'Other: Kinesics']}], 'interventions': [{'name': '- Postoperative Antagonistic Peripheral Magnetic Stimulation', 'type': 'PROCEDURE', 'otherNames': ['- Preoperative Peripheral Nerve Blockade', '- Selective Peripheral Neurotomy', '- Kinesic Rehabilitation Therapy'], 'description': 'Selected patients will be treated with Selective peripheral Neurotomy followed by an standartized cycle of Selective Peripheral Magnetic Stimulation and classic post operative Kinesic Therapy.\n\n* Sham patients (n 10) will be treated with classic post operative Kinesic Therapy.\n* Comparision of both groups will be statistified', 'armGroupLabels': ['Kinesics', 'Magnetic Stimulation', 'surgery']}, {'name': 'Selective Peripheral Magnetic Stimulation', 'type': 'DEVICE', 'description': 'Peripheral 1.5 tesla intensity, 10 Hz of Frequency, with "eight saped" bovine, of 30 minutes, aplied on antagonistic muscles, twice a week. Intensity will be infrathreshold, 80 per cent of the individual threshold (minimal amount of intensity producing always a muscle motor response in each particular patient)', 'armGroupLabels': ['Magnetic Stimulation']}, {'name': 'Kinesics', 'type': 'OTHER', 'otherNames': ['Classic Rehabilitation Treatment'], 'description': 'Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.', 'armGroupLabels': ['Kinesics', 'Magnetic Stimulation', 'surgery']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Juan Carlos Mario Andreani, MD', 'role': 'CONTACT', 'email': 'jcmandreani@gmail.com', 'phone': '91150531392'}], 'overallOfficials': [{'name': 'Juan Carlos Mario Andreani, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundación CENIT'}, {'name': 'Fabián César Piedimonte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundación CENIT - President'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Juan Carlos M. Andreani MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Juan Carlos M. Andreani MD', 'investigatorAffiliation': 'Sociedad Argenttina de Neuromodulación'}}}}