Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia

Ain Shams University

Status: Completed

Conditions: Secondary Dystonia

Treatments: Procedure: Combined anterior and posterior lumbosacral rhizotomy; Procedure: Brain Lesioning; Device: Deep brain stimulation; Device: Intra-thecal baclofen infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03347240

4996

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 3 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• secondary dystonia of previous etiologies

Exclusion criteria

• patients who are not candidate for anaesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Brain lesioning group

Active Comparator group

Description:

Stereotactic lesioning of the thalamus or gloves pallidus

Treatment:

Procedure: Brain Lesioning

Combined rhizotomy group

Active Comparator group

Description:

Combined anterior and posterior lumbosacral rhizotomy

Treatment:

Procedure: Combined anterior and posterior lumbosacral rhizotomy

Deep brain stimulation group

Active Comparator group

Description:

Bilateral globus pallidus internus deep brain stimulation

Treatment:

Device: Deep brain stimulation

Intra-thecal Baclofen infusion therapy

Active Comparator group

Description:

Intra-thecal infusion pump

Treatment:

Device: Intra-thecal baclofen infusion