Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
18 November 2015 Leanne Linard MP Chair Health and Ambulance Services Committee Parliament House George St. Brisbane QLD 4000 By email to: [email protected] Dear Ms Linard Re: Deep brain stimulation for paediatric mental health patients in Queensland The Royal Australian and New Zealand College of Psychiatrists (RANZCP) welcomes the opportunity to provide the Health and Ambulance Services Committee their views on deep brain stimulation (DBS) treatment for paediatric mental health patients in Queensland. In Australia DBS is a well-established procedure for the treatment of advanced movement disorders, particularly Parkinson’s disease. It has also been used to a much lesser extent to treat severe and medically intractable Tourette’s syndrome (TS) and obsessive compulsive disorder (OCD), yet it is not an established procedure to treat these disorders. Current research and clinical trials into the use of DBS to treat other psychiatric disorders such as depression, addiction, and anorexia are emerging worldwide. In Queensland, the Movement Disorders Clinic at St. Andrew’s War Memorial Hospital in Brisbane provides DBS for patients with TS and OCD, however the majority of patients at the hospital receive the treatment for Parkinson’s disease and other movement disorders. The hospital has considerable experience administering the procedure by international standards with approximately 800 DBS procedures carried out to date. A small number of DBS procedures to treat Parkinson’s disease are conducted each year at the Princess Alexandra Hospital in Brisbane. They are the only hospitals or clinics that conduct the DBS procedure in Queensland. There is little clinical evidence worldwide of the use of DBS to treat children or adolescents for movement disorders or psychiatric disorders. It is rare for the DBS procedure to be used to treat children or adolescents with psychiatric disorders, and in Australia it is not currently used to treat children or adolescents with psychiatric disorders. The RANZCP has prepared an information sheet overleaf on DBS. It provides information on the procedure, clinical indications, side effects, patient selection and consent, and the use of DBS in Australia. PO Box 261, RBH Post Office QLD 4029 Australia T +61 7 3852 2977 F +61 7 3852 2199 [email protected] www.ranzcp.org ABN 68 000 439 047 The RANZCP are committed to helping the Queensland Government develop an effective and robust Mental Health Act. If the Committee require further information with regards to this submission they are welcome to contact the RANZCP policy officer, Judith Johnston on (07) 3852 2977 or by [email protected]. Yours sincerely Associate Professor Mohan Gilhotra MBBS, MM, FRACMA, FRANZCP, FRCPsych Chair, RANZCP Queensland Branch Deep Brain Stimulation Information Sheet November 2015 working with the community PO Box 261, RBH Post Office QLD 4029 Australia T +61 7 3852 2977 F +61 7 3852 2199 [email protected] www.ranzcp.org ABN 68 000 439 047 Deep Brain Stimulation Introduction Deep Brian Stimulation (DBS) is a typically reversible therapeutic medical procedure that has been used to successfully treat patients suffering from movement disorders such as Parkinson’s disease, dystonia, and essential tremor. It is less commonly used or is under investigation for other disorders, such as epilepsy, Tourette’s syndrome (TS), depression, and obsessive compulsive disorder, amongst other disorders. What is DBS? The procedure involves delivering targeted electrical stimulation to specific brain regions, using permanently placed small electrodes to alleviate the symptoms of the disorder being treated. DBS is a neurosurgical procedure where stimulation electrodes are implanted into specific regions of the brain and receive continuous electrical stimulation by an impulse generator, which is implanted in the upper chest under the collarbone and connected to the electrodes under the skin by cables (leads). The pulse generator is also referred to as an ‘internal neural stimulator’ or ‘brain pacemaker’ (Coenen et al, 2015), and has a battery life of 1-5 years for those with externally chargeable batteries. After the patient has recovered from surgery, the impulse generator is turned on and various stimulation parameters (including voltage, pulse width and frequency) are adjusted to receive the optimal response to treat the symptoms of the disorder. The level of stimulation is individualised to the clinical requirements of each patient and the disorder being treated. Clinical Indications DBS is a well-established treatment for movement disorders such as Parkinson’s disease, tremor and dystonia in Australia and other countries. The use of DBS to treat movement disorders has been approved in the UK by the National Institute of Clinical Excellence and in the US by the Food and Drug Administration, although in the US it is also approved for the treatment of OCD. In Australia, the DBS procedure for the treatment of Parkinson’s disease is eligible for reimbursement under the Medicare Benefits Schedule however there may be considerable out-of-pocket costs. The DBS procedure for other psychiatric or neurological disorders is not eligible for reimbursement. RANZCP Fellows are currently conducting a randomised, controlled trial of DBS for severe treatment resistant OCD at St Andrew's War Memorial Hospital in Brisbane. An independent mental health review tribunal determines patient candidacy for the trial and those under the age of 18 are excluded. Anecdotal evidence from RANZCP Fellows concur that it is extremely rare for children or adolescents to be treated for any type of disorder using DBS and there are no scientific reports of DBS being undertaken for psychiatric disorders in children under 16. DBS is not currently used in Australia as a means to treat children or adolescents. A review of current literature on DBS for psychiatric disorders displays a mix of criticism and cautious optimism for the treatment, but agree that a stronger clinical evidence base of randomised control trials is necessary to identify the procedure’s efficacy and safety. Coenen et al (2015) describes the use of DBS in the treatment of psychiatric disorders, such as depression, substance abuse and schizophrenia as ‘experimental’. Kiseley et al (2014) also states that DBS is an intervention that should be considered an experimental treatment in adults with severe, medically refractory psychiatric disorders. Fitzgerald & Deep Brain Stimulation: Information Sheet Page 2 of 5 Segrave, (2015) comment that whilst there is promising initial data to support the efficacy of DBS as a form of treatment for psychiatric disorders, there is insufficient evidence at present to support the use of DBS as a clinical treatment for psychiatric disorders outside of research and clinical trials. Whilst Mosley et al (2015) describe how DBS may be an option for patients suffering from the most severe forms of intractable depression, as many patients suffer from residual depressive symptoms that fail to remit with existing biological and psychological therapies. Also, RANZCP Fellows are aware it has been argued that there is sufficient preliminary evidence to make DBS available for adult patients with highly treatment resistant OCD, this is evident in its use and approval in the US by the Food and Drug Administration. Adverse Effects In terms of adverse effects, there are mainly two types of concerns associated with DBS, those directly related to the surgical procedure and the implanted device hardware, and those that are a result of the electrical stimulation. As with any surgical procedure, there are potential side effects. The adverse effects related to the surgical procedure include haemorrhage (1-2% of procedures), seizure induction (less than 1% usually in the first 24 hours), infection (2-3% usually superficial) and other general surgical or anaesthetic complications (Fitzgerald & Segrave, 2015). With regards to the implanted hardware device, adverse effects include hardware malfunctioning or cables breaking, however with advances in device technology the authors suggest these affects are likely to become uncommon. Research indicates that the side effects of electrical stimulation differ and depend upon which disorder is being treated and then which targets of the brain are being stimulated. For instance, Fraint and Pal (2015) describe a range of side effects to electrical stimulation including: changes in sexual behaviour, weight loss, psychiatric symptoms (e.g. psychosis, depression and hypomania), nausea, vertigo, anxiety, agitation, euphoria, panic, fear and worsening depression. Due to the ‘trial and error’ style of searching for optimal stimulation settings, the side effects may be fleeting and reversible via adjustment of the stimulators, or may be stopped by ceasing the stimulation altogether (Fitzgerald and Segrave, 2015). An example of the success and side effects of DBS in a psychiatric disorder is Kiseley et al’s (2014) meta-analysis of 5 studies of DBS for severe treatment resistant OCD patients (only 5 studies met the meta-analysis criteria). The main outcome of the analysis was a significant reduction in obsessive symptoms indicated by the pooled reduction in Yale–Brown Obsessive Compulsive Scale score of 9 points (scale out of 40). However one third of patients experienced serious adverse effects (including haemorrhage, hypomanic symptoms, forgetfulness, increased libido, paraesthesias). Patient Selection and Consent Due to the invasiveness of the DBS procedure the screening and selection of candidates is essential and most importantly be reserved for patients who have a severe treatment resistant disorder, and by most definitions this requires many years of illness (e.g. 5 years). This should be conducted ideally by a multidisciplinary team that includes a specialist neurosurgeon and a psychiatrist or neurologist depending on the indicated use, all with appropriate training and expertise in DBS. Deep Brain Stimulation: Information Sheet Page 3 of 5 Generally, agreed guidelines exist for patient selection for DBS for movement disorders, yet there are not necessarily guidelines for DBS for other neurological or psychiatric disorders. For instance, Fraint and Pal (2015) point out that there are no universally accepted guidelines defining ideal DBS candidates for Tourette’s syndrome. Although important factors to consider are age, tic severity and treatment refractoriness. A review of the literature shows that important factors for the screening and selection of candidates for DBS include the candidate’s age (how it relates to the disorder), severity of the disorder, treatment refractoriness, and presence of psychiatric symptoms. If the patient has a history of psychosis or depression then post-operative monitoring of these symptoms is essential (Ashkan et al, 2013). Due to the complexities of undertaking a DBS procedure, informed patient consent is necessary for patients considering DBS and should be required in legislation controlling access to this procedure. The procedure is not suitable for use as an involuntary intervention. Due to the lack of clinical evidence of the effectiveness or safety of DBS for treating children or adolescents with psychiatric disorders, use in this population should be considered highly experimental. It is recommended that this age group should not be considered for this treatment at this time except in an ethically approved and appropriately regulated clinical trial. Consideration of the procedure in exceptional circumstances should be via a legally mandated review process. It is suggested that in Queensland this could occur through either the Mental Health Review Tribunal or the Family Court (which has provision for decision making that is in the best interests of the child or adolescent). DBS Administration The DBS procedure should ideally be conducted by a multidisciplinary team that includes a neurosurgeon and a psychiatrist or neurologist depending on the indicated use with appropriate training and expertise in DBS, and be located at a hospital or clinic that is experienced in carrying out the procedure. In Queensland, the Movement Disorders Clinic at St Andrews War Memorial Hospital in Brisbane carries out DBS for patients with movement disorders and severe treatment resistant TS. It is the only hospital or clinic that conducts the DBS procedure to treat psychiatric disorders in Queensland. New South Wales and the Northern Territory are the only state and territory to ban the DBS procedure to treat psychiatric disorders, yet not neurological disorders. Although this has been criticised for limiting patients’ equality of access to health care which is a fundamental element of the right to health (Loo et al, 2010). Future Directions There appears to be great scope and enthusiasm worldwide for the use of DBS to treat psychiatric disorders, yet further research and clinical trials are required to develop a substantial body evidence to support its efficacy and safety, particularly for child and adolescent patients. Deep Brain Stimulation: Information Sheet Page 4 of 5 References Ashkan K., Shotbolt P., Anthony D. & Samuel M. (2013) Deep brain stimulation: a return journey from psychiatry to neurology. Postgraduate Medical Journal 89: 323-328. Coenen V. A., Amtage F., Volkmann J. & Schläpfer T. E. (2015) Deep brain stimulation in neurological and psychiatric disorders. Deutsches Ärtzeblatt International 112: 519-26. Fitzgerald P. B. & Segrave R. A. (2015) Deep brain stimulation in mental health: Review of evidence for clinical efficacy. Australian & New Zealand Journal of Psychiatry 49(11): 979-993. Fraint A. & Pal G. (2015) Deep brain stimulation in Tourette’s syndrome. Frontiers in Neurology 6(170): 1-7. Kiseley S., Hall K., Siskind D., Frater J., Olson S. & Crompton D. (2014) Deep brain stimulation in obsessive compulsive disorder a systematic review and meta-analysis. Psychological Medicine 44: 3533-3542. Loo C., Trollor J., Alonzo A., Rendina N. & Kavess R. (2010) Mental health legislation and psychiatric treatments in NSW: electroconvulsive therapy and deep brain stimulation. Australasian Psychiatry 18(5): 417-425. Mosley P., Marsh R. & Carter A. (2015) Deep brain stimulation for depression: Scientific issues and future directions. Australian & New Zealand Journal of Psychiatry 49(11): 967-978. Deep Brain Stimulation: Information Sheet Page 5 of 5