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Completed

NCT Number: NCT03347240

Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia

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

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Key information

Conditions

Secondary Dystonia Central Nervous System Diseases Dystonic Disorders Movement Disorders Nervous System Diseases

Age range

3 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • secondary dystonia of previous etiologies

Exclusion criteria

  • patients who are not candidate for anaesthesia

Treatment and study plan

Brain Lesioning

Procedure

Stereotactic radiofrequency lesioning of the pallidum or thalamus

Combined anterior and posterior lumbosacral rhizotomy

Procedure

Combined anterior and posterior lumbosacral rhizotomy

Deep brain stimulation

Device

Bilateral DBS

Other names: DBS

Intra-thecal baclofen infusion

Device

Intra-thecal Baclofen infusion

Other names: ITB

Primary outcomes

  1. Burke-Fahn-Marsden dystonia rating scale

    Time frame: 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 outcomes

  1. Modified Ashworth scale

    Time frame: 1 year

    Muscle tone scale

  2. Barthel index

    Time frame: 1 year

    Disability score

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2017
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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