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There is a need for better treatments for spasticity in cerebral palsy (CP). Spasticity is a common target for many established treatments for CP such as Botulinum toxin A injection, oral baclofen, intrathecal baclofen pump implantation, and selective dorsal rhizotomy surgery. For over 40 years there have been attempts to use spinal cord stimulation (SCS) to treat spasticity, yet its role as a treatment in cerebral palsy has been limited. Recent advances in technology have enabled closed-loop control of SCS devices meaning that targeted electrical stimulation of the spinal cord can now be used in a real world setting with a device that is not adversely affected by sudden movements in posture, such as from muscle spasms. This technological advance combined with evidence relating to the importance of early intervention in cerebral palsy have led to the initiation of this trial. The Liberty Trial investigates the use of closed loop spinal cord stimulation in the treatment of lower limb spasticity for children living with spasticity. Children between 6 and 16 years with CP and spasticity predominately affecting at least one lower limb and who are candidates for SCS will be enrolled. The total study duration is 36 months. The study enrolment period is expected to be 12 months, and participants implanted with the investigational device will be followed for 24 months from implant. Treatment safety will be investigated, and efficacy will be determined by evaluation of the outcome measures at determined time-points using defined performance criteria. Additionally; the patient demographics, diagnosis and prior anti-spasticity treatments will be documented. The intervention in this trial consists of the implantation of an electronic medical device, a spinal cord stimulator, known as the EvokeTM Closed Loop Stimulator and leads, to reduce lower limb spasticity in children living with cerebral palsy. Intensive physiotherapy will accompany the intervention to try to improve lower limb function and mobility. This will be performed face to face by a physiotherapist experienced in post-spasticity intervention rehabilitation (i.e. botulinum toxin and selective dorsal rhizotomy). The principles of Goal Directed Therapy will be followed to compare the ability of the participants to achieve meaningful functional goals before and after the intervention.

Selective dorsal rhizotomy (SDR) is a well-established neurosurgical intervention intended to permanently reduce spasticity in the lower limbs and improve mobility in selected children with cerebral palsy. The aim of this study is to establish a retrospective and prospective national registry of relevant data pertaining to children undergoing SDR in Australia, and overseas (selection, intervention and outcome). Centres across Australia have agreed on a group of standardised assessments for children undergoing SDR both prior to and after the surgical procedure. The objective of collecting this data is to improve understanding of the short, medium and long term outcomes and any adverse effects of the intervention, and to provide clinicians with information to guide families considering this intervention. Families of children who have undergone or are undergoing SDR (in Australia, and overseas) will be asked to consent to information relevant to SDR being stored in a research-specific online database. Information will be collected from the children's routine clinical assessments. Information will be stored without identifying details to improve privacy. Participation in this trial is voluntary. Data collected in the registry will identify the characteristics of Australian children who have undergone SDR. In addition to details of the surgery including surgical complications; long term adverse events; and outcomes related to the International Classification of Functioning, Disability and Health domains of body structure and function, activity and participation. The primary and secondary outcome measures have been developed for the CP and/or paediatric population and will be collected at baseline, and at one, two, five and ten years post intervention. These include gross motor function and mobility, achievement of goals, pain and quality of life. The need for further interventions after SDR surgery will be collected and include spasticity management and orthopaedic interventions in the ten years following SDR. The prevalence of any long term adverse effects will be collected in the ten years following SDR. The data collected pertaining to adverse events include spine and foot deformity, hip subluxation, sensory impairment and bladder/bowel dysfunction.