Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000385044
Ethics application status
Approved
Date submitted
5/03/2010
Date registered
13/05/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Deep Brain Stimulation for Cerebral Palsy
Scientific title
A randomized, placebo controlled, double blinded trial of pallidal Deep Brain Stimulation for dystonic or dyskinetic Cerebral Palsy to improve Quality of Life
Secondary ID [1] 251731 0
None
Universal Trial Number (UTN)
U1111-1114-0874
Trial acronym
DBS for CP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 256910 0
Condition category
Condition code
Neurological 257058 257058 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will have deep brain stimulator implanted in the globus pallidus internus, which is part of the basal ganglia network in the brain. The implantation of deep brain stimulators takes approximately 3 to 6 hours. Deep brain stimulators are similar to cardiac pacemakers and the battery is placed - like in pacemakers - under the collar bone. However the electrodes are not in the heart but end in the brain where they stimulate certain areas of the brain - in our study the pallidum or globus pallidus internus. This part of the brain is involved in involuntary movements. We believe that continuous high frequency stimulation of this part of the brain can block involuntary movements and improve dystonia. The treatment group will receive effective continuous stimulation through their implanted deep brain stimulators for three months; The standard setting of the stimulator are pulse width of 90µs, 130 Hz and the highest possible amplitude , that does not cause side effects. The sham group will receive ineffective stimulation through their implanted deep brain stimulators which will mean the stimulator is switched on with the same settings but amplitude of 0 Volt.
Intervention code [1] 256107 0
Treatment: Surgery
Intervention code [2] 256467 0
Treatment: Other
Comparator / control treatment
All patients will have deep brain stimulator implanted in the globus pallidus internus, which is part of the basal ganglia network in the brain. The implantation of deep brain stimulators takes approximately 3 to 6 hours. Deep brain stimulators are similar to cardiac pacemakers and the battery is placed - like in pacemakers - under the collar bone. However the electrodes are not in the heart but end in the brain where they stimulate certain areas of the brain - in our study the pallidum or globus pallidus internus. This part of the brain is involved in involuntary movements. We believe that continuous high frequency stimulation of this part of the brain can block involuntary movements and improve dystonia. The treatment group will receive effective continuous stimulation through their implanted deep brain stimulators for three months; The standard setting of the stimulator are pulse width of 90µs, 130 Hz and the highest possible amplitude , that does not cause side effects. The sham group will receive ineffective stimulation through their implanted deep brain stimulators which will mean the stimulator is switched on with the same settings but amplitude of 0 Volt.
Control group
Placebo

Outcomes
Primary outcome [1] 257950 0
Quality of life will be assessed by the Quality of Life Instrument for People with Developmental Disabilities (Rosenbaum, P.L., et al., Quality of life and health-related quality of life of adolescents with cerebral palsy. Dev Med Child Neurol, 2007. 49(7): p. 516-21.) with the domains of Being, Belonging, and Becoming. This scale is validated in Cerebral Palsy (CP). The health-related quality of life will be assessed with the Short Form General-Health-Survey (SF-36), which evaluates both physical and mental components of functioning (Ware, J.E., Jr. and C.D. Sherbourne, The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care, 1992. 30(6): p. 473-83).
Timepoint [1] 257950 0
The primary outcome parameter will be measured within 2 months before the intervention. Within 48 hours after implantation of the deep brain stimulator patients will be randomised and either allocated to sham or active treatment. Three months after the randomisation and therefore three months after having had continuous effective deep brain stimulation or sham stimulation the primary endpoint will be assed again. Than all deep brain stimulators will be activated and the third assessment of the primary endpoint will be 6 months after the initial randomisation.
Secondary outcome [1] 263478 0
Movement and disability will be assessed by the Burke-Fahn-Marsden-Dystonia Rating Scale (BFMDRS) (Burke, R.E., et al., Validity and reliability of a rating scale for the primary torsion dystonias. Neurology, 1985. 35(1): p. 73-7.), which comprises of a disability score ranging from 0 to 30 and motor score ranging from 0 to 120. Further more the motor function will be video taped according to the previous applied video protocol.
The Gross Motor Function Classification System for children with Cerebral Palsy (GMFCS) [Palisano, R., et al., Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol, 1997. 39(4): p. 214-23.] will be applied as a standard classification tool for children with CP, which rates the severity of the disease in 5 levels with regard to their motor function.
Timepoint [1] 263478 0
The secondary outcome parameter will be measured within 2 months before the intervention. Within 48 hours after implantation of the deep brain stimulator patients will be randomised and either allocated to sham or active treatment. Three months after the randomisation and therefore three months after having had continuous effective deep brain stimulation or sham stimulation the secondary endpoint will be assed again. Than all deep brain stimulators will be activated and the third assessment of the secondary endpoint will be 6 months after the initial randomisation.

Eligibility
Key inclusion criteria
Dystonic or dyskinetic Cerebral Palsy
Minimum age
10 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia
Predominant Spasticity

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256602 0
Self funded/Unfunded
Name [1] 256602 0
Country [1] 256602 0
Australia
Primary sponsor type
Individual
Name
Martin Krause
Address
Sydney Medical School | Nepean
THE UNIVERSITY OF SYDNEY
Level 5, Spurrett Building | Nepean Hospital
Derby Street | Kingswood | NSW | 2747
PO Box 63 | Penrith | NSW | 2751
Country
Australia
Secondary sponsor category [1] 255895 0
None
Name [1] 255895 0
Address [1] 255895 0
Country [1] 255895 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30898 0
Address 30898 0
Country 30898 0
Phone 30898 0
Fax 30898 0
Email 30898 0
Contact person for public queries
Name 14145 0
A/Professor Martin Krause
Address 14145 0
Sydney Medical School Nepean
THE UNIVERSITY OF SYDNEY
Level 5, Spurrett Building | Nepean Hospital
Derby Street | Kingswood | NSW | 2747
PO Box 63 | Penrith | NSW | 2751
Country 14145 0
Australia
Phone 14145 0
+61 2 47344280
Fax 14145 0
Email 14145 0
[email protected]
Contact person for scientific queries
Name 5073 0
A/Professor Martin Krause
Address 5073 0
Sydney Medical School Nepean
THE UNIVERSITY OF SYDNEY
Level 5, Spurrett Building | Nepean Hospital
Derby Street | Kingswood | NSW | 2747
PO Box 63 | Penrith | NSW | 2751
Country 5073 0
Australia
Phone 5073 0
+61 2 47344280
Fax 5073 0
Email 5073 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.