alexa Effect of Deep Brain Stimulation of the Globus Pallidus Internus on Quality of Life in Young Patients with Dyskinetic Cerebral Palsy (STIM-CP): a Prospective Single-Arm Multicenter Trial with a Double-Blind Cross-Over at 12-Months Follow-up
ISSN: 2167-0870

Journal of Clinical Trials
Open Access

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Protocol

Effect of Deep Brain Stimulation of the Globus Pallidus Internus on Quality of Life in Young Patients with Dyskinetic Cerebral Palsy (STIM-CP): a Prospective Single-Arm Multicenter Trial with a Double-Blind Cross-Over at 12-Months Follow-up

Anne Koy1*, Andrea A. Kühn2, Anne van Riesen3, Julius Huebl2, Rudolf Korinthenberg4, Volker A. Coenen5,6, Joachim K. Krauss7, Andreas Wloch7, Delia Lorenz8, Martin Häussler8, Alfons Schnitzler9, Jan Vesper10, Francois Alesch11, Walter Lehmacher12, Joerg Mueller13, Guntram Borck14, Karsten Witt15,16,Tobias Bäumer17, Steffen Berweck18, Sebastian Schröder19, Jürgen Voges20, Reinhild Prinz-Langenohl21, Veerle Visser-Vandewalle22, Martin Hellmich12, Lars Timmermann23,24 and STIM-CP investigators

1Department of Pediatrics, University Hospital Cologne, Germany

2Department of Neurology, Charité University Medicine Berlin, Germany

3Center for Chronically Sick Children, Department of Neuropediatrics, Charité University Medicine Berlin, Germany

4Department of Neuropediatrics and Muscular Disorders, Medical Center, Faculty of Medicine, University of Freiburg, Germany

5Department of Stereotactic and Functional Neurosurgery, Freiburg University Medical Center, Germany

6Medical Faculty, Freiburg University, Freiburg i.Br., Germany

7Department of Neurosurgery, Medical School, MHH, Hannover, Germany

8Department of Pediatrics, University Hospital Würzburg, Germany

9Department of Neurology, University Hospital of Düsseldorf, Germany

10Department of Functional and Stereotactic Neurosurgery, University Hospital of Düsseldorf, Germany

11Department of Neurosurgery, University Hospital of Vienna, Austria

12Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Germany

13Department of Neurology, Vivantes Klinikum Spandau, Berlin, Germany

14Institute of Human Genetics, University of Ulm, Germany

15Department of Neurology, University Hospital of Schleswig-Holstein, Campus Kiel, Germany

16Deptartment of Neurology, Carl von Ossietzky University Oldenburg, Evangelic Hospital, Marienweg 11, 26121 Oldenburg, Germany

17Department of Neurology, University Hospital of Schleswig-Holstein, Campus Lübeck, Germany

18Department of Pediatrics, Schön Klinik, Vogtareuth, Germany

19Department of Pediatrics, University Hospital Munich, Germany

20Department of Stereotactic Neurosurgery, University-Hospital Magdeburg and Leibniz-Institute for Neurobiology, Magdeburg, Germany

21Clinical Trials Center Cologne, Medical Faculty, University of Cologne, Germany

22Department of Stereotactic and Functional Neurosurgery, University Hospital Cologne, Germany

23Department of Neurology, University Hospital of Cologne, Germany

24Department of Neurology, University Hospital of Marburg, Germany

*Corresponding Author:
Anne Koy
Department of Pediatrics
University Hospital Cologne, Germany
Tel: +49-(0)221-478-5900
E-mail: [email protected]

Received Date: July 11, 2017; Accepted Date: July 20, 2017; Published Date: July 24, 2017

Citation: Koy A, Kuhn AA, van Riesen A, Huebl J, Korinthenberg R, et al. (2017) Effect of Deep Brain Stimulation of the Globus Pallidus Internus on Quality of Life in Young Patients with Dyskinetic Cerebral Palsy (STIM-CP): a Prospective Single-Arm Multicenter Trial with a Double-Blind Cross-Over at 12-Months Follow-up. J Clin Trials 7:1000317. doi: 10.4172/2167-0870.1000317

Copyright: © 2017 Koy A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use,distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Introduction: Deep brain stimulation of the globus pallidus internus (GPi-DBS) can be effective in patients with dyskinetic cerebral palsy (CP), but outcome in terms of dystonia severity is often less pronounced and more variable compared to patients with inherited monogenic dystonia. A few published case series encompassing retrospective data have shown that GPi-DBS is associated with favorable quality of life outcomes, even in patients without changes in the BFMDRS, suggesting that the sole use of clinical rating scales may not reflect the full effects of DBS, especially not in patients with acquired forms of dystonia such as dyskinetic CP. However, there is no prospective data on DBS effects in children.
We hypothesize an improvement in quality of life by GPi-DBS. Therefore, the mean change in the CPCHILD questionnaire from baseline to 12 months is chosen as the primary outcome parameter. Secondary outcome parameters encompass dystonia severity, motor function, speech, mood, cognition, pain, and quality of life of the carers before and up to 36 months after implantation.
Methods: This is a prospective single-arm study to investigate the effects of GPi-DBS in young patients with dyskinetic CP. 20 patients aged 7-18 years will be recruited in a multicenter setting. 12 months after lead implantation patients are randomized by a double-blind cross-over into two groups: One group starts with ongoing stimulation, in the other group stimulation is turned off. After 24 h they switch stimulation settings. Dystonia severity will be assessed at the end of each phase.
We hypothesize an improvement in quality of life by GPi-DBS. Therefore, the mean change in the CPCHILD questionnaire from baseline to 12 months is chosen as the primary outcome parameter. Secondary outcome parameters encompass dystonia severity, motor function, speech, mood, cognition, pain, and quality of life of the carers before and up to 36 months after implantation.
Discussion: This is the first prospective trial investigating the effects of GPi-DBS on motor and non-motor outcome in a cohort of exclusively pediatric patients in a multicenter setting. Furthermore, long-term data on effects and side effects of GPi-DBS in young patients with dyskinetic cerebral palsy will be generated.

Keywords

Share This Page

Additional Info

Loading
Loading Please wait..
 
Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri & Aquaculture Journals

Dr. Krish

[email protected]

1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

General Science

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001Extn: 9042

 
© 2008- 2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords