DBS in the Treatment of Intractable Movement Disorders
Deep Brain Stimulation in the Treatment of Intractable Movement Disorders ( Parkinson's Disease, Essential Tremors and Dystonia)
1 other identifier
interventional
16
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJune 19, 2018
June 1, 2018
9 months
May 22, 2018
June 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
baseline(pre-DBS )and 6 months post-DBS
Secondary Outcomes (1)
Change in antiparkinsonian medication use
baseline(pre-DBS and 6 months post-DBS
Study Arms (1)
DBS on patients with abnormal movement disorders
EXPERIMENTAL16 patients with intractable abnormal movement disorders (Parkinson's disease, Essential tremors and Dystonia)
Interventions
stimulation of different basal ganglionic nuclei by a inserting a device
Eligibility Criteria
You may qualify if:
- Dopa responsiveness
- Minimum disease duration of 5 years.
- Diagnosis of idiopathic Parkinsons disease
- Patients with intractable Essential Tremors.
- Patients with intractable dystonia
You may not qualify if:
- Significant medical health problems.
- Significant cognitive impairment
- Bleeding tendencies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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: 12566335RESULTJankovic 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.
PMID: 8559296RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amr Elnaggar, MD
University of Louisville
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer in the Department of Neurosurgery
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 19, 2018
Study Start
July 1, 2018
Primary Completion
April 1, 2019
Study Completion
July 1, 2019
Last Updated
June 19, 2018
Record last verified: 2018-06