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

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

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• secondary dystonia of previous etiologies

Exclusion Criteria:

• patients who are not candidate for anaesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Brain lesioning group; Stereotactic lesioning of the thalamus or gloves pallidus	Procedure: Brain Lesioning; Stereotactic radiofrequency lesioning of the pallidum or thalamus
Active Comparator: Combined rhizotomy group; Combined anterior and posterior lumbosacral rhizotomy	Procedure: Combined anterior and posterior lumbosacral rhizotomy; Combined anterior and posterior lumbosacral rhizotomy
Active Comparator: Deep brain stimulation group; Bilateral globus pallidus internus deep brain stimulation	Device: Deep brain stimulation; Bilateral DBS; Other Names: DBS
Active Comparator: Intra-thecal Baclofen infusion therapy; Intra-thecal infusion pump	Device: Intra-thecal baclofen infusion; Intra-thecal Baclofen infusion; Other Names: ITB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth scale	Muscle tone scale	1 year
Barthel index	Disability score	1 year

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Walid A Abdel Ghany, MD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: November 12, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neurologic Manifestations; Movement Disorders; Dyskinesias; Neoplastic Processes; Neoplasm Metastasis; Dystonia; Dystonic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; GABA Agents; Neuromuscular Agents; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Baclofen
• Other Study ID Numbers: 4996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No