Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia

Study Overview
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Brief Summary
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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

Detailed Description
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Background: 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.

Official Title
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Comparative Study Between the Functional Outcomes of Neuromodulation and Neuroablation Techniques for Treatment of Secondary Dystonia

Conditions
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Secondary Dystonia

Intervention / Treatment
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* Procedure: Brain Lesioning
* Procedure: Combined anterior and posterior lumbosacral rhizotomy
* Device: Deep brain stimulation
* Device: Intra-thecal baclofen infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: secondary dystonia of previous etiologies Exclusion Criteria: patients who are not candidate for anaesthesia

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brain lesioning group<br>Stereotactic lesioning of the thalamus or gloves pallidus | Procedure: Brain Lesioning<br>* Stereotactic radiofrequency lesioning of the pallidum or thalamus<br>|
| Active Comparator: Combined rhizotomy group<br>Combined anterior and posterior lumbosacral rhizotomy | Procedure: Combined anterior and posterior lumbosacral rhizotomy<br>* Combined anterior and posterior lumbosacral rhizotomy<br>|
| Active Comparator: Deep brain stimulation group<br>Bilateral globus pallidus internus deep brain stimulation | Device: Deep brain stimulation<br>* Bilateral DBS<br>* Other names: DBS;|
| Active Comparator: Intra-thecal Baclofen infusion therapy<br>Intra-thecal infusion pump | Device: Intra-thecal baclofen infusion<br>* Intra-thecal Baclofen infusion<br>* Other names: ITB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth scale | Muscle tone scale | 1 year | 
| Barthel index | Disability score | 1 year |