The Liberty Trial: Investigating spinal cord stimulation as a new treatment for spasticity of the legs in children living with cerebral palsy

Not Applicable

• Conditions: Spasticity; Cerebral Palsy; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Neurological - Other neurological disorders

• Registration Number: ACTRN12622000130763
• Lead Sponsor: Closed Loop Medical Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-27
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified