Treatment including surgery versus treatment without surgery for people with symptoms due to a cavernoma in the brain

INTERVENTION: This prospective randomised open blinded end‐point (PROBE) randomised controlled trial (RCT) aims to estimate the feasibility of performing a definitive main phase RCT comparing medical management to medical and surgical management (with neurosurgery or Gamma Knife stereotactic radiosurgery, according to their availability in clinical practice) for improving outcome for people with symptomatic brain cavernoma. Randomisation will allocate participants to groups in a 1:1 ratio, stratified by preferred type of surgical treatment, but if there is no clear preference for the type of surgical treatment, and both are available, the patient will be randomly allocated to either neurosurgery or stereotactic radiosurgery. The trial design includes an integrated QuinteT Recruitment Intervention (QRI) which aims to understand recruitment barriers (e.g. related to selection of patients during screening and recruitment processes, or equipoise etc), and optimise informed consent and recruitment processes in the trial. In one arm of the trial, participants will receive brain cavernoma treatment without surgery that is available in standard clinical practice. This may include anti‐epileptic drugs to prevent epileptic seizures, rehabilitation of neurological deficits (e.g. physiotherapy, speech and language therapy), medical treatment of other neurological symptoms (e.g. headache, body pain, spasticity, dysaesthesia), and psychological support. In standard clinical practice, these treatments are usually provided for as long as they are required or likely to benefit patients. In the other arm of the trial, participants will receive brain cavernoma treatment including surgery that is available in standard clinical practice. CONDITION: Brain cavernoma ; Nervous System Diseases SECONDARY OUTCOME: ; Measured at 6‐monthly follow‐up until the end of the trial:; 1. Death not due to a primary clinical outcome measured using patient records; 2. Seizure severity and frequency measured using the Liverpool Seizure Severity Scale plus epileptic seizure frequency (number of seizures in the preceding four weeks, and attainment of one‐year seizure freedom); 3. Degree of disability or dependence in the daily activities measured using the Modified Rankin Scale (mRS) score; 4. Impairment caused by stroke measured using the National Institute of Health Stroke Scale Score (adult or paediatric); 5. Quality of life measured using the EQ‐5D‐5L in adults and EQ‐5D‐Y in children; 6. Functional status measured using the Karnofsky Performance Status (KPS) scale in adults and Lanksy Play‐Performance Scale (LPPS) in children; 7. Health service use and healthcare and socioeconomic costs measured from patient records; PRIMARY OUTCOME: ; Feasibility measured using the following questions answered using assessment if investigator and participant records at the end of the trial:; 1. What proportion of the collaborating centres take part and recruit participants to the CARE pilot trial?; 2. Can the investigators implement trial procedures correctly?; 3. What proportion of screened patients is eligible?; 4. What proportions of eligible patients are approached and randomised (and why are eligible patients not approached or not randomised)?; 5. What is the distribution of participants between neurosurgery and stereotactic radiosurgery?; 6. Do participants adhere to the allocated intervention and follow‐up?; 7. How complete are baseline, imaging and outcome data?; 8. What are the outcome event rates?; 9. How do the baseline characteristics, outcome event rates and differences between treatment groups compare to observational data about outcomes during medical management or after medical and surgical management?; 10. What estimates of effect size/variability should be used in the design of the CARE definitive main phase trial?; 11. What is the sample size required for a definitive trial to address the overall question over a 10‐year follow‐up?; 12. Can the CARE pilot trial data describe care pathways, linked to health states and outcomes, to develop a robust economic model to evaluate cost effectiveness in a CARE definitive main phase trial?; 13. Which international research partners in other countries could contribute to the CARE definitive main phase trial?; ; Primary clinical outcome:; Intracranial haemorrhage or new persistent/progressive focal neurological deficit due to brain cavernoma or surgical management (neurosurgery or stereotactic radiosurgery), whether fatal (leading to death within 30 days of the outcome event) or non‐fatal measured using patient records at 6‐monthly follow‐up until the end of the trial; INCLUSION CRITERIA: 1. People of any age 2. At least one brain cavernoma diagnosed by brain MRI that included a gradient echo or susceptibility‐weighted sequence, according to standard diagnostic criteria 3. Clinical history attributable to a brain cavernoma of: 3.1. Symptomatic stroke due to intracranial haemorrhage, or 3.2. Symptomatic stroke due to a persistent or progressive non‐haemorrhagic, or not otherwise specified, focal neurological deficit, or 3.3. Epileptic seizure(s) meeting the definition of definite or probable cavernoma‐related epilepsy 4. Patient and doctor are uncertain about medical management or medical and surgical management of the symptomatic brain cavernoma, following consultation with a neurosurgeon 5. Patient has mental capacity to consent for themselves (adult participants or paediatric participants with capa