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Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia

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ClinicalTrials.gov Identifier: NCT03347240
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Nada, Ain Shams University

Brief 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


Condition or disease Intervention/treatment Phase
Secondary Dystonia Procedure: Brain Lesioning Procedure: Combined anterior and posterior lumbosacral rhizotomy Device: Deep brain stimulation Device: Intra-thecal baclofen infusion Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study Between the Functional Outcomes of Neuromodulation and Neuroablation Techniques for Treatment of Secondary Dystonia
Actual Study Start Date : December 1, 2013
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

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 Name: DBS

Active Comparator: Intra-thecal Baclofen infusion therapy
Intra-thecal infusion pump
Device: Intra-thecal baclofen infusion
Intra-thecal Baclofen infusion
Other Name: ITB




Primary Outcome Measures :
  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 Outcome Measures :
  1. Modified Ashworth scale [ Time Frame: 1 year ]
    Muscle tone scale

  2. Barthel index [ Time Frame: 1 year ]
    Disability score



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • secondary dystonia of previous etiologies

Exclusion Criteria:

  • patients who are not candidate for anaesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347240


Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Walid A Abdel Ghany, MD Associate professor

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Responsible Party: Mohamed Nada, Fellow, Ain Shams University
ClinicalTrials.gov Identifier: NCT03347240     History of Changes
Other Study ID Numbers: 4996
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases