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