Effect of DBS on Quality of Life in Dyskinetic Cerebral Palsy (STIM-CP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital of Cologne
Sponsor:
Collaborators:
University of Luebeck
Boston Scientific Corporation
University Magdeburg
University Munich
University Vogtareuth
University Hospital Tuebingen
University Düsseldorf
University Hannover
University Kiel
University Würzburg
University of Freiburg
University Berlin
Information provided by (Responsible Party):
Prof. Dr. Lars Timmermann, University of Cologne
ClinicalTrials.gov Identifier:
NCT02097693
First received: March 24, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

There are limited therapeutical options for patients with secondary dystonia due to cerebral palsy. Pharmacotherapy is often without effect, or side effects are severe. Meanwhile deep brain stimulation (DBS) has proven to be a safe and effective therapy for patients with parkinson´s disease or primary / idiopathic dystonia. Experiences with DBS in patients with dyskinetic cerebral palsy are limited with heterogeneous data.

With STIM-CP we investigate the effect of DBS on quality of life in young patients with a dyskinetic movement disorder (dyskinetic cerebral palsy) due to perinatal hypoxic brain injury. Additionally, the effect of DBS on motor development, speech, memory, attention, cognition and pain perception will be assessed. In total, 20 patients aged 7-18 years diagnosed with dyskinetic cerebral palsy, who will receive DBS, should be included. 11 German DBS-centres will participate in the trial.

We assume that DBS reduces the severity of dystonia and improves the quality of life in these patients.


Condition
Dyskinetic Cerebral Palsy Due to Perinatal Hypoxia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Deep Brain Stimulation in the Globus Pallidus Internus on Quality of Life in Young Patients With Dyston-dyskinetic Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by University Hospital of Cologne:

Primary Outcome Measures:
  • Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) [ Time Frame: CPCHILD 12 months after DBS ] [ Designated as safety issue: No ]
    Difference in CPCHILD before and 12 months on DBS (response=improvement > 10%)


Secondary Outcome Measures:
  • Burke-Fahn-Marsden-Dystonia Rating Scale movement and disability [ Time Frame: 0, 6 and 12 months after DBS ] [ Designated as safety issue: No ]
  • Dyskinesia Impairment Scale [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]
  • Tardieu Scale [ Time Frame: 0 and 12 months after DBS ] [ Designated as safety issue: No ]
  • Frenchay Dysarthria Assessment [ Time Frame: 0 and 12 months after DBS ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: 0, 6 and 12 months after DBS ] [ Designated as safety issue: No ]
  • Strengths and Difficulties Questionnaire [ Time Frame: 0, 6 and 12 months after DBS ] [ Designated as safety issue: No ]
  • Snijders-Oomen-Non-Verbal-Intelligence Test (SON-R) [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]
  • Attentional Network Test (ANT) [ Time Frame: 0 and 12 months after DBS ] [ Designated as safety issue: No ]
  • Non-Verbal-Learning Test (NVLT) [ Time Frame: 0 and 12 months after DBS ] [ Designated as safety issue: No ]
  • Wong Baker Faces [ Time Frame: 0, 6 and 12 months after DBS ] [ Designated as safety issue: No ]
  • Family Scale (FaBel) [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
  • CPCHILD [ Time Frame: 0 and 6 months after DBS ] [ Designated as safety issue: No ]
  • Canadian Occupational Performance Measure (COPM) [ Time Frame: COPM 0 and 12 months after DBS ] [ Designated as safety issue: No ]
  • Gross Motor Function Measure (GMFM-66) [ Time Frame: GMFM-66 0 and 12 months after DBS ] [ Designated as safety issue: No ]
  • Gross Motor Function Classification System (GMFCS) [ Time Frame: GMFCS 0 and 12 months after DBS ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

EDTA-plasma for DYT1-testing


Estimated Enrollment: 20
Study Start Date: February 2014
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
dyston-dyskinetic cerebral palsy
Young patients with dyston-dyskinetic cerebral palsy who receive DBS in the GPi

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • The treating physician has chosen GPi-DBS for the treatment of the secondary dystonia caused by cere-bral palsy in this patient
  • Patient and/or legal representative, if the patient is underaged or not capable to give consent himself, have chosen GPi-DBS as treatment
  • The consent to participate in the trial of the underaged patient, if he is capable to understand the study requirements, is required
  • Age at enrolment 7-18 years
  • Diagnosis of secondary dystonia due to cerebral palsy caused by perinatal hypoxic injury
  • Anti-dystonic pharmacotherapy insufficient (e.g. Jankovic J. Medical treatment of dystonia. Movement disorders, Vol. 28, No. 7, 2013) 67
  • Stable anti-dystonic medication over the last 30 days
  • Globus pallidus internus (pars posterior) and thalamus (motor part) intact on MRI (not older than 2 years - if possible)
  • No fixed severe skeletal deformations with loss of function, which need immediate orthopaedic surgical intervention
  • Sufficient compliance of the patient or the legal representative if the patient is underaged or not capable to give consent himself to take part in the study
  • Informed consent to take part in the study from patient and/or legal representative if the patient is underaged or not capable to give consent himself
  • Patient and/or legal representative if the patient is underaged or not capable to give consent himself, understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed

Exclusion Criteria:

  • • Patients with known primary (e.g. DYT1) or idiopathic dystonia

    • Severe axial hypotonia with total loss of head control (e.g. absence of control at "upper thoracic level" in the SATCo score) (medication effect excluded)
    • Fixed hemi-dystonia
    • Severe spasticity in knee- and elbow-flexors and -extensors (Modified Ashworth Scale >3)
    • Fixed severe skeletal contractions with loss of function which require immediate orthopaedic surgical intervention
    • Patients with other severe concurrent neurological disease (e. g. brain tumor, neurodegenerative diseases, trauma etc.)
    • Condition likely to require use of MRI in the future
    • Any intracranial abnormality or medical condition that would contraindicate DBS surgery
    • Any findings in neuropsychological screening assessments that would contraindicate DBS surgery
    • Any current drug and / or alcohol abuse
    • Any history of frequent grand-mal seizures without response to anticonvulsive treatment
    • Any other active implanted device (e.g. Cochlear implant, pacemaker), whether turned on or off, would be allowed provided that they do not interfere with functioning of the device.
    • Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
    • A history of neurostimulation intolerance in any area of the body.
    • Currently on any anticoagulant medications that cannot be discontinued during perioperative period.
    • Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
    • Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days; any other trial participation should be approved by the Principal Investigator.
    • A female that is breastfeeding or of child bearing potential with a positive urine pregnancy test or - if a person is sexually active - not using sufficient contraception with a Pearl Index of less than 1% including all forms of hormonal contraception ("antibaby-pill", hormonal plaster, NuvaRing®, Implanon®, hormonal depot injections, contraceptive coil), the tubal ligature (female sterilization). Alternatively, the female of child bearing potential is sexually abstinent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097693

Contacts
Contact: Lars Timmermann, Professor 0049-221-478-7494 lars.timmermann@uk-koeln.de
Contact: Alin Milke 0049-221-478-87353 alin.milke@uk-koeln.de

Locations
Germany
University Hospital Cologne Recruiting
Cologne, Northern Westfalia, Germany, 50935
Contact: Anne Koy, MD    +49-(0)221-478-0 ext 87353    anne.koy@uk-koeln.de   
Contact: Alin Milke, study nurse    +49-(0)221-478-87353    alin.milke@uk-koeln.de   
Sub-Investigator: Anne Koy, MD         
Sponsors and Collaborators
University Hospital of Cologne
University of Luebeck
Boston Scientific Corporation
University Magdeburg
University Munich
University Vogtareuth
University Hospital Tuebingen
University Düsseldorf
University Hannover
University Kiel
University Würzburg
University of Freiburg
University Berlin
Investigators
Principal Investigator: Lars Timmermann, Professor of Neurology University Hospital Cologne, Germany
  More Information

No publications provided

Responsible Party: Prof. Dr. Lars Timmermann, Univ.-Prof. Dr. Lars Timmermann, University of Cologne
ClinicalTrials.gov Identifier: NCT02097693     History of Changes
Other Study ID Numbers: Uni-Koeln-1603
Study First Received: March 24, 2014
Last Updated: March 24, 2014
Health Authority: Germany: Ethic Commission, Mastervote in University of Cologne, Germany

Keywords provided by University Hospital of Cologne:
DBS
quality of life
dystonia
dyskinetic cerebral palsy

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014