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DBS in the Treatment of Intractable Movement Disorders

Primary Purpose

Parkinson Disease, Essential Tremors and Dystonia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease, Essential Tremors and Dystonia focused on measuring deep brain stimulation

Eligibility Criteria

25 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Dopa responsiveness
  2. Minimum disease duration of 5 years.
  3. Diagnosis of idiopathic Parkinsons disease
  4. Patients with intractable Essential Tremors.
  5. Patients with intractable dystonia

Exclusion Criteria:

  1. Significant medical health problems.
  2. Significant cognitive impairment
  3. Bleeding tendencies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    DBS on patients with abnormal movement disorders

    Arm Description

    16 patients with intractable abnormal movement disorders (Parkinson's disease, Essential tremors and Dystonia)

    Outcomes

    Primary Outcome Measures

    Change in the unified parkinson's disease rating scale score
    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. Part 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

    Secondary Outcome Measures

    Change in antiparkinsonian medication use
    the percent in reduction of antiparkinsonian medications used after DBS

    Full Information

    First Posted
    May 22, 2018
    Last Updated
    June 18, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03562403
    Brief Title
    DBS in the Treatment of Intractable Movement Disorders
    Official Title
    Deep Brain Stimulation in the Treatment of Intractable Movement Disorders ( Parkinson's Disease, Essential Tremors and Dystonia)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2018 (Anticipated)
    Primary Completion Date
    April 2019 (Anticipated)
    Study Completion Date
    July 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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. Hyperkinetic 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. Hypokinetic 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. The 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). Surgical 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. Parkinson'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. Since 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?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease, Essential Tremors and Dystonia
    Keywords
    deep brain stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DBS on patients with abnormal movement disorders
    Arm Type
    Experimental
    Arm Description
    16 patients with intractable abnormal movement disorders (Parkinson's disease, Essential tremors and Dystonia)
    Intervention Type
    Device
    Intervention Name(s)
    Deep Brain Stimulation
    Intervention Description
    stimulation of different basal ganglionic nuclei by a inserting a device
    Primary Outcome Measure Information:
    Title
    Change in the unified parkinson's disease rating scale score
    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. Part 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
    Time Frame
    baseline(pre-DBS )and 6 months post-DBS
    Secondary Outcome Measure Information:
    Title
    Change in antiparkinsonian medication use
    Description
    the percent in reduction of antiparkinsonian medications used after DBS
    Time Frame
    baseline(pre-DBS and 6 months post-DBS

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Dopa responsiveness Minimum disease duration of 5 years. Diagnosis of idiopathic Parkinsons disease Patients with intractable Essential Tremors. Patients with intractable dystonia Exclusion Criteria: Significant medical health problems. Significant cognitive impairment Bleeding tendencies
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Nouby, masters degree
    Phone
    +201222336729
    Email
    ahrano2015@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hanan Omar, PhD
    Phone
    +01223971654
    Email
    hannahomar@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amr Elnaggar, MD
    Organizational Affiliation
    University of Louisville
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12566335
    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. Erratum In: CMAJ. 2003 Mar 4;168(5):544.
    Results Reference
    result
    PubMed Identifier
    8559296
    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.
    Results Reference
    result

    Learn more about this trial

    DBS in the Treatment of Intractable Movement Disorders

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