Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT03562403
Status:
UNKNOWN
Last Update Posted:
2018-06-19
First Post:
2018-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DBS in the Treatment of Intractable Movement Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020329', 'term': 'Essential Tremor'}, {'id': 'D004421', 'term': 'Dystonia'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in the unified parkinson's disease rating scale score", 'timeFrame': 'baseline(pre-DBS )and 6 months post-DBS', 'description': "The Unified Parkinson's Disease Rating Scale (UPDRS) is a commonly used survey tool used to assess symptom severity of patients with Parkinson's disease (PD). It covers several different domains including 1) thought, behavior and mood 2) activities of daily living 3) motor activity 4) complications of therapy and others.\n\nPart I: evaluation of mentation, behavior, and mood Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food Part III: clinician-scored monitored motor evaluation Part IV: complications of therapy Part V: Hoehn and Yahr staging of severity of Parkinson's disease Part VI: Schwab and England ADL scale"}], 'secondaryOutcomes': [{'measure': 'Change in antiparkinsonian medication use', 'timeFrame': 'baseline(pre-DBS and 6 months post-DBS', 'description': 'the percent in reduction of antiparkinsonian medications used after DBS'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['deep brain stimulation'], 'conditions': ['Parkinson Disease, Essential Tremors and Dystonia']}, 'referencesModule': {'references': [{'pmid': '12566335', 'type': 'RESULT', 'citation': "Guttman M, Kish SJ, Furukawa Y. Current concepts in the diagnosis and management of Parkinson's disease. CMAJ. 2003 Feb 4;168(3):293-301."}, {'pmid': '8559296', 'type': 'RESULT', 'citation': 'Jankovic J, Cardoso F, Grossman RG, Hamilton WJ. Outcome after stereotactic thalamotomy for parkinsonian, essential, and other types of tremor. Neurosurgery. 1995 Oct;37(4):680-6; discussion 686-7. doi: 10.1227/00006123-199510000-00011.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to observe the efficacy of Deep Brain Stimulation in the treatment of Parkinson's disease,Essential Tremors and Dystonia in our locality.", 'detailedDescription': "Movement disorders are clinical syndromes result from disturbances of basal ganglia function with either an excess of movement or a paucity of voluntary and involuntary movements, unrelated to weakness or spasticity. Movement disorders are synonymous with basal ganglia or extrapyramidal diseases. Movement disorders are conventionally divided into two major categories-hyperkinetic and hypokinetic.\n\nHyperkinetic movement disorders refer to excessive, often repetitive, involuntary movements that intrude upon the normal flow of motor activity and it includes include Essential Tremors, Dystonia, Chorea, Dyskinesia, and Athetosis.\n\nHypokinetic movement disorders refer to akinesia (lack of movement), hypokinesia (reduced amplitude of movements), bradykinesia (slow movement) and rigidity. In primary movement disorders, the abnormal movement is the primary manifestation of the disorder. In secondary movement disorders, the abnormal movement is a manifestation of another systemic or neurological disorder.\n\nThe basal ganglia include the striatum (caudate. putamen, nucleus accumbens), the subthalamic nucleus (STN), the globuspallidus \\[internal segment. external segment, ventral pallidum (VP)\\]. and the substantianigra pars compacta (SNpc) and substantianigra pars reticulata (SNpr).\n\nSurgical therapies for the treatment of movement disorders can be divided into two broad categories: ablative and restorative. The most common structures targeted during stereotactic surgery for movement disorders are the motor thalamus, the globuspallidus internus and the subthalamic nucleus. Ablative surgical therapies for Movement disorders include thalamotomy and pallidotomy. Restorative surgical therapies include deep brain stimulation and transplantation of fetal tissue, cell lines that express trophic factors, or somatically delivered gene therapies. The theoretical advantage of Deep Brain Stimulation over ablative procedures is the lack of tissue destruction especially with deep brain stimulation. This is particularly appealing for patients needing bilateral procedures.\n\nParkinson's disease is the best example of a hypokinetic movement disorder. The interest in surgery has been prompted by the growing realization of the limitations of drug therapy for these movement disorders, improvement in neuroimaging capabilities, enhanced stereotactic surgical techniques and better understanding of functional organization of the basal ganglia and its pathophysiology of these movement disorders. There are many theories on how does Deep Brain Stimulation works in the treatment of movement disorders, these theories include Neurostimulation, Neuroinhibition, and Release of neurotransmitters. Deep brain has the following advantages over ablative surgery: No destruction of brain tissue can adjust stimulus parameters, Perform bilateral operations, significant reduction (50-75%) in medication, and it is completely reversible.\n\nSince the introduction of deep brain stimulation almost 20 years ago, there has been an immense resurgence in interest in the surgical technique. However, the investigators are still asking some of the same questions. How can the investigators improve the targeting? What is the optimal target? In addition, the investigators have started asking some new questions such as how does deep brain stimulation work, and what other disorders can deep brain stimulation be applied to?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Dopa responsiveness\n2. Minimum disease duration of 5 years.\n3. Diagnosis of idiopathic Parkinsons disease\n4. Patients with intractable Essential Tremors.\n5. Patients with intractable dystonia\n\nExclusion Criteria:\n\n1. Significant medical health problems.\n2. Significant cognitive impairment\n3. Bleeding tendencies'}, 'identificationModule': {'nctId': 'NCT03562403', 'briefTitle': 'DBS in the Treatment of Intractable Movement Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': "Deep Brain Stimulation in the Treatment of Intractable Movement Disorders ( Parkinson's Disease, Essential Tremors and Dystonia)", 'orgStudyIdInfo': {'id': 'DBS in movement disorders'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DBS on patients with abnormal movement disorders', 'description': "16 patients with intractable abnormal movement disorders (Parkinson's disease, Essential tremors and Dystonia)", 'interventionNames': ['Device: Deep Brain Stimulation']}], 'interventions': [{'name': 'Deep Brain Stimulation', 'type': 'DEVICE', 'description': 'stimulation of different basal ganglionic nuclei by a inserting a device', 'armGroupLabels': ['DBS on patients with abnormal movement disorders']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Nouby, masters degree', 'role': 'CONTACT', 'email': 'ahrano2015@gmail.com', 'phone': '+201222336729'}, {'name': 'Hanan Omar, PhD', 'role': 'CONTACT', 'email': 'hannahomar@yahoo.com', 'phone': '+01223971654'}], 'overallOfficials': [{'name': 'Amr Elnaggar, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Louisville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer in the Department of Neurosurgery', 'investigatorFullName': 'Ahmed Radwan Nouby', 'investigatorAffiliation': 'Assiut University'}}}}