Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia

Secondary Dystonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347240
• Other study ID #: 4996
• Status: Completed
• Phase: N/A
• First received: November 12, 2017
• Last updated: November 15, 2017
• Start date: December 1, 2013
• Est. completion date: December 31, 2016

Study information

• Verified date: November 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 50 Years

Eligibility

Inclusion Criteria:

• secondary dystonia of previous etiologies

Exclusion Criteria:

• patients who are not candidate for anaesthesia

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Neoplasm Metastasis
• Secondary Dystonia

Intervention

Procedure:
• Brain Lesioning
Stereotactic radiofrequency lesioning of the pallidum or thalamus
• Combined anterior and posterior lumbosacral rhizotomy
Combined anterior and posterior lumbosacral rhizotomy

Device:
• Deep brain stimulation
Bilateral DBS
• Intra-thecal baclofen infusion
Intra-thecal Baclofen infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Modified Ashworth scale	Muscle tone scale	1 year
Secondary	Barthel index	Disability score	1 year