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Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia

Primary Purpose

Secondary Dystonia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brain Lesioning
Combined anterior and posterior lumbosacral rhizotomy
Deep brain stimulation
Intra-thecal baclofen infusion
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Dystonia

Eligibility Criteria

3 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • secondary dystonia of previous etiologies

Exclusion Criteria:

  • patients who are not candidate for anaesthesia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Brain lesioning group

    Combined rhizotomy group

    Deep brain stimulation group

    Intra-thecal Baclofen infusion therapy

    Arm Description

    Stereotactic lesioning of the thalamus or gloves pallidus

    Combined anterior and posterior lumbosacral rhizotomy

    Bilateral globus pallidus internus deep brain stimulation

    Intra-thecal infusion pump

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Modified Ashworth scale
    Muscle tone scale
    Barthel index
    Disability score

    Full Information

    First Posted
    November 12, 2017
    Last Updated
    November 15, 2017
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03347240
    Brief Title
    Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia
    Official Title
    Comparative Study Between the Functional Outcomes of Neuromodulation and Neuroablation Techniques for Treatment of Secondary Dystonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2013 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Secondary Dystonia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Brain lesioning group
    Arm Type
    Active Comparator
    Arm Description
    Stereotactic lesioning of the thalamus or gloves pallidus
    Arm Title
    Combined rhizotomy group
    Arm Type
    Active Comparator
    Arm Description
    Combined anterior and posterior lumbosacral rhizotomy
    Arm Title
    Deep brain stimulation group
    Arm Type
    Active Comparator
    Arm Description
    Bilateral globus pallidus internus deep brain stimulation
    Arm Title
    Intra-thecal Baclofen infusion therapy
    Arm Type
    Active Comparator
    Arm Description
    Intra-thecal infusion pump
    Intervention Type
    Procedure
    Intervention Name(s)
    Brain Lesioning
    Intervention Description
    Stereotactic radiofrequency lesioning of the pallidum or thalamus
    Intervention Type
    Procedure
    Intervention Name(s)
    Combined anterior and posterior lumbosacral rhizotomy
    Intervention Description
    Combined anterior and posterior lumbosacral rhizotomy
    Intervention Type
    Device
    Intervention Name(s)
    Deep brain stimulation
    Other Intervention Name(s)
    DBS
    Intervention Description
    Bilateral DBS
    Intervention Type
    Device
    Intervention Name(s)
    Intra-thecal baclofen infusion
    Other Intervention Name(s)
    ITB
    Intervention Description
    Intra-thecal Baclofen infusion
    Primary Outcome Measure Information:
    Title
    Burke-Fahn-Marsden dystonia rating scale
    Description
    Dystonia rating scale Higher scores means a worse condition of the disease, while low scores indicate a less involvement of the body
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Modified Ashworth scale
    Description
    Muscle tone scale
    Time Frame
    1 year
    Title
    Barthel index
    Description
    Disability score
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: secondary dystonia of previous etiologies Exclusion Criteria: patients who are not candidate for anaesthesia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Walid A Abdel Ghany, MD
    Organizational Affiliation
    Associate professor
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia

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