None listed
Conditions
Brief summary
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.
Interventions
The intervention in this trial consists of the implantation of an electronic active medical device, a spinal cord stimulator, known as the Evoke™ Closed Loop Stimulator with implantable leads, is aimed to reduce lower limb spasticity in children living with cerebral palsy (CP).
The implantation surgery usually takes about 1 hour and is performed by a qualified paediatric neurosurgeon under complete anaesthesia.
The participants are followed up for a duration of 2 years with scheduled visits at 1
The intervention in this trial consists of the implantation of an electronic active medical device, a spinal cord stimulator, known as the Evoke™ Closed Loop Stimulator with implantable leads, is aimed to reduce lower limb spasticity in children living with cerebral palsy (CP). The implantation surgery usually takes about 1 hour and is performed by a qualified paediatric neurosurgeon under complete anaesthesia. The participants are followed up for a duration of 2 years with scheduled visits at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months after the implantation surgery. Usage logs and outcome measures are collected at each visit. Within 7±2 days following device activation, each participant will begin up to 40 hours of Intensive Physiotherapy (IPT) to be completed within 8 weeks of initiating it (duration and number of visits are at the discretion of the participant and their physiotherapist). The physiotherapy will be provided by an accredited physiotherapist and the program will be patient specific according to their identified goals. As such, the physiotherapy program will be tailored to each patient and their goals and patients won’t necessarily share common exercises. A common goal is the ability to dress autonomously and exercises will include movements to help the patients circumvent their spasticity to achieve the desired outcome. Other common goals will be the ability to walk up and down stairs or bend down to pick up objects. The exercise programs will be tailored to help the patients achieve these goals by adapting their movements taking into consideration limitations caused by their spasticity. Their goals and progress will be captured periodically using the COPM and GAS forms and will be evaluated at baseline during the intensive physiotherapy phase and at 3, 6, 12 months after the device implantation.
Sponsors
Closed Loop Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Individuals who meet the following criteria will be considered potential candidates for this clinical study: 1. Have been diagnosed with spasticity in at least one lower limb muscle group in at least one leg as a result of CP (Modified Ashworth Scale 2 or greater in one muscle group) 2. Have spastic diplegia, hemiplegia or quadriplegia 3. Minimal dyskinesia or ataxia 4. No spinal deformity 5. Have a Gross Motor Function Classification System (GMFCS) level of 2 to 5 6. Have been approved to undergo SCS of the spinal cord and be an appropriate candidate for the surgical procedure required in this study based on the clinical judgment of the Eligibility Advisory Panel 7. Be on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain or spasticity medications for at least 30 days prior to baseline evaluation 8. Subject is between 6 to 16 years of age at the time of consent; 9. Be willing and capable of giving written informed consent, and/or have a parent/guardian who is willing to sign informed consent on their behalf 10. Be willing and able to comply with study-related requirements, procedures, and visits
Exclusion criteria
Individuals who meet any one of the following criteria will be excluded from this clinical study: 1. Show presence of progressive neurological disease 2. Have drug resistant epilepsy (International League Against Epilepsy criteria) 3. Have ever been diagnosed with an immune system disorder or immune deficiency syndrome 4. Require ventilator support 5. Be unwell, or if the participant’s medical condition does not allow safe travel 6. Have had, or are scheduled for, lower limb botulinum-A toxin or surgery affecting the lower limbs within 3 months prior to device activation or 6 months following device activation 7. Have an implanted pacemaker, implanted ITB pump, previous spinal surgery (including SDR) and or any other system that may interfere with the EvokeTM CLS 8. Have a condition currently requiring or likely to require the use of MRI or diathermy 9. Have a life expectancy of less than two years 10. Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body 11. Be concomitantly participating in another clinical study unless pre-approved by Closed Loop Medical 12. Have intellectual disability (diagnosed with a presumed Intellectual Disability as determined by a psychologist with the relevant expertise or having an Intellectual Quotient (IQ) <69 as tested on a standardised measure)
Outcome results
None listed