Deep brain stimulation before the age of 18 in patients with childhood-onset dyskinetic movement disorders - a German registry for quality assurance
Organizational Data
- DRKS-ID:
- DRKS00006778
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2014-12-01
- Last update in DRKS:
- 2015-02-13
- Registration type:
- Retrospective
Acronym/abbreviation of the study
GEPESTIM
URL of the study
No Entry
Brief summary in lay language
Deep brain Stimulation (DBS) has proven to be a safe and effective therapy for primary dystonia. The results in patients with aquired dystonia are variable. So far there is only little data about the effect of deep brain stimulation on movement disorders in paediatric patients. With the the registry all available data of patients with a childhood-onset dyskinetic movement disorder who received DBS before the age of 18 years should be collected. The pre-, peri- and postoperative data encompass medical history of the patients, etiology of disease, evolution of symptoms, pharmacotherapy and supportive therapy, technical details of the DBS implantation, stimulation parameters and complications. The analysis of this data should help to evaluate the effect of DBS comprehensively and to identify possible outcome predictors in order to improve counselling of affected families and to select suitable patients. Furthermore, treatment standards should be created to optimize the service of young patients undergoing DBS.
Brief summary in scientific language
Deep brain Stimulation (DBS) has proven to be a safe and effective therapy for primary dystonia. The results in patients with secondary dystonia are heterogeneous. So far there is only little data about the effect of deep brain stimulation (DBS) on movement disorders in paediatric patients. With the the registry all available data of patients with a childhood-onset dyskinetic movement disorder who received DBS before the age of 18 years should be collected. The pre-, peri- and postoperative data encompass medical history of the patients, etiology of disease, evolution of symptoms, pharmacotherapy and supportive therapy, technical details of the DBS implantation, stimulation parameters and complications. The analysis of this data should help to evaluate the effect of DBS comprehensively and to identify possible outcome predictors in order to improve counselling of affected families and to select suitable patients. Furthermore, treatment standards should be created to optimize the service of young patients undergoing DBS.
Health condition or problem studied
- ICD10:
- G80.3 - Dyskinetic cerebral palsy
- ICD10:
- G24.1 - Idiopathic familial dystonia
- ICD10:
- G23.0 - Hallervorden-Spatz disease
- ICD10:
- E79.1 - Lesch-Nyhan syndrome
- ICD10:
- G24.2 - Idiopathic nonfamilial dystonia
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- With the aid of the registry data of patients with a childhood-onset dyskinetic movement disorder who received DBS before the age of 18 years should be systematically collected encompassing information on medical history of the patients, disease etiology, evolution of symptoms, pharmacotherapy, supportive therapy, technical details of DBS implantation, stimulation parameters and complications.
Endpoints
- Primary outcome:
- Change of Burke-Fahn-Marsden Dystonia Rating Scale after Deep Brain Stimulation
- Secondary outcome:
- Deep Brain Stimulation effect on - dystonia - dyskinesia - pain - memory - affect - quality of life - spasticity - motor function - cognition - attention - speech
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Neurologie Düsseldorf
- Medical center Stereotaxie Hannover
- Medical center Neurologie Köln
- Medical center Neurologie Berlin
- Medical center Pädiatrie Freiburg im Breisgau
- Medical center Neurologie Kiel
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2013-10-14
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 60
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Diagnosis of childhood-onset dyskinetic movement disorders - Deep brain stimulation before the age of 18
Exclusion Criteria
- No diagnosis of childhood-onset dyskinetic movement disorders - Deep brain stimulation after the age of 18
Addresses
Primary Sponsor
- Address:
- University of CologneAlbertus-Magnus-Platz50923 CologneGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Uniklinik Köln NeurologieUniv.-Prof. Lars TimmermannKerpenerstr. 6250937 KölnGermany
- Telephone:
- 022147887444
- Fax:
- 02214789002
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Uniklinik Köln NeurologieDr. Anne KoyKerpenerstr. 6250937 KölnGermany
- Telephone:
- 022147887353
- Fax:
- 022147889002
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Uniklinik Köln NeurologieUniv.-Prof. Lars TimmermannKerpenerstr. 6250937 KölnGermany
- Telephone:
- 022147887444
- Fax:
- 02214789002
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Univerität zu KölnAlbertus-Magnus-Platz50925 KölnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät der Universität zu KölnGleueler Str. 26950935 KölnGermany
- Telephone:
- +49-221-478 82900
- Fax:
- +40-221-478 82905
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2013-08-07
- Ethics committee number:
- 13-168
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2013-10-07
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry