Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia
NCT ID: NCT03347240
Last Updated: 2017-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2013-12-01
2016-12-31
Brief Summary
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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
Detailed Description
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Secondary dystonia are the syndromes that have dystonic symptoms due to brain insult which can be associated with neonatal encephalopathy syndromes, trauma, vascular injury, infections, demyelinations, or hereditary disorders associated with neurodegenerative process. The disability inflected by dystonia encouraged the development of many neurosurgical procedures in order to improve the quality of life of these patients.
The aim of this study was to compare the outcomes of different Neuroablative and modulation techniques in treatment of secondary dystonia.
Patients and methods This is a prospective study included 120 patients suffering from intractable secondary dystonia. Ablative techniques included the brain lesioning procedure and combined anterior and posterior lumbar rhizotomy (CAPR). Modulation techniques included deep brain stimulation (DBS) and intrathecal baclofen therapy (ITB). Patients with focal dystonia were included in the Botulinum toxin injection group. Patients with generalized dystonia were included in either of the brain lesioning or the deep brain stimulation, and patients with predominant affection of both lower limbs were included in either of the (CAPR) or the (ITB) groups.
Assessment measures included the evaluation of the muscle tone, range of motion, and the Burke-Fahn-Marsden dystonia rating scale through a follow up period of one year.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Brain lesioning group
Stereotactic lesioning of the thalamus or gloves pallidus
Brain Lesioning
Stereotactic radiofrequency lesioning of the pallidum or thalamus
Combined rhizotomy group
Combined anterior and posterior lumbosacral rhizotomy
Combined anterior and posterior lumbosacral rhizotomy
Combined anterior and posterior lumbosacral rhizotomy
Deep brain stimulation group
Bilateral globus pallidus internus deep brain stimulation
Deep brain stimulation
Bilateral DBS
Intra-thecal Baclofen infusion therapy
Intra-thecal infusion pump
Intra-thecal baclofen infusion
Intra-thecal Baclofen infusion
Interventions
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Brain Lesioning
Stereotactic radiofrequency lesioning of the pallidum or thalamus
Combined anterior and posterior lumbosacral rhizotomy
Combined anterior and posterior lumbosacral rhizotomy
Deep brain stimulation
Bilateral DBS
Intra-thecal baclofen infusion
Intra-thecal Baclofen infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Years
50 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Mohamed Nada
Fellow
Principal Investigators
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Walid A Abdel Ghany, MD
Role: STUDY_DIRECTOR
Associate professor
Other Identifiers
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4996
Identifier Type: -
Identifier Source: org_study_id