NCT03347240

Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 3 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Secondary Dystonia

Interventions

Type	Name	Description
PROCEDURE	Brain Lesioning	Stereotactic radiofrequency lesioning of the pallidum or thalamus
PROCEDURE	Combined anterior and posterior lumbosacral rhizotomy	Combined anterior and posterior lumbosacral rhizotomy
DEVICE	Deep brain stimulation	Bilateral DBS
DEVICE	Intra-thecal baclofen infusion	Intra-thecal Baclofen infusion

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2017-11-20
• Last updated: 2017-11-20