Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia

Not Applicable

Completed

• Conditions: Secondary Dystonia
• Interventions: Device: Intra-thecal baclofen infusion; Device: Deep brain stimulation; Procedure: Brain Lesioning; Procedure: Combined anterior and posterior lumbosacral rhizotomy

• Registration Number: NCT03347240
• Lead Sponsor: Ain Shams University

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-12-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-11
• Study First Submitted: 2017-11-12
• Study First Submitted QC: 2017-11-15
• Last Update Submitted: 2017-11-15
• Study First Posted: 2017-11-20
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• secondary dystonia of previous etiologies

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Exclusion Criteria

• patients who are not candidate for anaesthesia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-thecal Baclofen infusion therapy	Intra-thecal baclofen infusion	Intra-thecal infusion pump
Deep brain stimulation group	Deep brain stimulation	Bilateral globus pallidus internus deep brain stimulation
Brain lesioning group	Brain Lesioning	Stereotactic lesioning of the thalamus or gloves pallidus
Combined rhizotomy group	Combined anterior and posterior lumbosacral rhizotomy	Combined anterior and posterior lumbosacral rhizotomy

Primary Outcome Measures

Name	Time	Method
Burke-Fahn-Marsden dystonia rating scale	1 year	Dystonia rating scale Higher scores means a worse condition of the disease, while low scores indicate a less involvement of the body

Secondary Outcome Measures

Name	Time	Method
Barthel index	1 year	Disability score
Modified Ashworth scale	1 year	Muscle tone scale