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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

Tracking Information
First Submitted Date  ICMJE November 12, 2017
First Posted Date  ICMJE November 20, 2017
Last Update Posted Date November 20, 2017
Actual Study Start Date  ICMJE December 1, 2013
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
  • Modified Ashworth scale [ Time Frame: 1 year ]
    Muscle tone scale
  • Barthel index [ Time Frame: 1 year ]
    Disability score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia
Official Title  ICMJE Comparative Study Between the Functional Outcomes of Neuromodulation and Neuroablation Techniques for Treatment of Secondary Dystonia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Secondary Dystonia
Intervention  ICMJE
  • 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
    Other Name: DBS
  • Device: Intra-thecal baclofen infusion
    Intra-thecal Baclofen infusion
    Other Name: ITB
Study Arms  ICMJE
  • Active Comparator: Brain lesioning group
    Stereotactic lesioning of the thalamus or gloves pallidus
    Intervention: Procedure: Brain Lesioning
  • Active Comparator: Combined rhizotomy group
    Combined anterior and posterior lumbosacral rhizotomy
    Intervention: Procedure: Combined anterior and posterior lumbosacral rhizotomy
  • Active Comparator: Deep brain stimulation group
    Bilateral globus pallidus internus deep brain stimulation
    Intervention: Device: Deep brain stimulation
  • Active Comparator: Intra-thecal Baclofen infusion therapy
    Intra-thecal infusion pump
    Intervention: Device: Intra-thecal baclofen infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2017)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • secondary dystonia of previous etiologies

Exclusion Criteria:

  • patients who are not candidate for anaesthesia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03347240
Other Study ID Numbers  ICMJE 4996
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mohamed Nada, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Walid A Abdel Ghany, MD Associate professor
PRS Account Ain Shams University
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP