Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia
Comparative Study Between the Functional Outcomes of Neuromodulation and Neuroablation Techniques for Treatment of Secondary Dystonia
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
The disability inflected by dystonia encouraged the development of many neurosurgical procedures. This is a prospective study included 120 patients suffering from intractable secondary dystonia. They were subjected to different neurosurgical treatments and were assessed through the follow up period
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedFirst Submitted
Initial submission to the registry
November 12, 2017
CompletedFirst Posted
Study publicly available on registry
November 20, 2017
CompletedNovember 20, 2017
November 1, 2017
3.1 years
November 12, 2017
November 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Burke-Fahn-Marsden dystonia rating scale
Dystonia rating scale Higher scores means a worse condition of the disease, while low scores indicate a less involvement of the body
1 year
Secondary Outcomes (2)
Modified Ashworth scale
1 year
Barthel index
1 year
Study Arms (4)
Brain lesioning group
ACTIVE COMPARATORStereotactic lesioning of the thalamus or gloves pallidus
Combined rhizotomy group
ACTIVE COMPARATORCombined anterior and posterior lumbosacral rhizotomy
Deep brain stimulation group
ACTIVE COMPARATORBilateral globus pallidus internus deep brain stimulation
Intra-thecal Baclofen infusion therapy
ACTIVE COMPARATORIntra-thecal infusion pump
Interventions
Stereotactic radiofrequency lesioning of the pallidum or thalamus
Combined anterior and posterior lumbosacral rhizotomy
Intra-thecal Baclofen infusion
Eligibility Criteria
You may qualify if:
- secondary dystonia of previous etiologies
You may not qualify if:
- patients who are not candidate for anaesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Walid A Abdel Ghany, MD
Associate professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellow
Study Record Dates
First Submitted
November 12, 2017
First Posted
November 20, 2017
Study Start
December 1, 2013
Primary Completion
December 31, 2016
Study Completion
December 31, 2016
Last Updated
November 20, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share