Original Title: Estimulación cerebral profunda en trastornos neurológicos y psiquiátricos

Authors' objectives: • To review current scientific evidence to determine the therapeutic indications of DBS for neurological and neuropsychiatric disorders. • To assess the effectiveness, safety and cost-effectiveness of DBS for neurological and neuropsychiatric disorders in which therapeutic potential has been investigated.

Authors' results and conclusions: RESULTS: A total of 1377 references were found in the electronic databases. After removing duplicates, 1180 references were obtained, of which 114 were selected. We finally included 34 references (31 studies): 19 SR (11 with MA, 7 without MA, 1 about EE-CS), 8 about RCTs not included in the RS (5 studies), 3 EE and 1 CS not included in the RS about EE-CS, and 3 caes series about esential tremor. Of 19 SR, 7 are associated with Parkinson's disease (6 about effectiveness, and 1 about EE-CS). Also related to effectiveness, we identified 6 SR on Dystonia, 1 on Essential Tremor, 1 on Tremor associated with Multiple Sclerosis, 1 on Tics associated with Tourette Syndrome, 2 on other psychiatric disorders, and 1 about all conditions in which DBS has been used. Three out of the RCTs identified (5 references) were about Parkinson’s disease, 1 for dystonia and 1 for epilepsy. Regarding EE, 1 studies were identified for Parkinson (apart from the five ones included in the RS), 1 for Dystonia, and 1 for Addictions. The CS considers the DBS as a treatment for Parkinson's disease in Spain. Most excluded studies were narrative reviews, or SR that did not include MA. CONCLUSIONS: DBS represents an alternative for the treatment of differents neurological and neuropsychiatric disorders that do not respond to conventional treatments adequately. There has been an increased number of severe adverse events (AE) in the case of DBS vs. medication, although there is considerable variability between studies, which suggests that this intervention should be conducted only by expert teams in the surgical technique. Most AEs observed were resolved spontaneously within a few months or after adjustments in the stimulation. Also, it has been observed an increased number of deaths in patients with ECP versus medication related to the risk associated with the surgical procedure. About neurocognitive effects, the most consistent effect was observed in verbal fluency, and in a lesser extent, on memory. The strongest evidence corresponds to its application in Parkinson's Disease (PD), demonstrating its effectiveness in the reduction of motor signs until three years, and improved quality of life. The review of economic studies established that in terms of cost and cost-effectiveness, the DBS seems the most convenient alternative for patients with advanced PD. In primary dystonia (generalized or segmental), data from MA of nonrandomized studies, as well as the only found RCT show significant benefits of DBS up to five years. In other disorders there is no evidence from any RCT, except one that shows the efficacy of DBS in the treatment of temporal epilepsy. A MA of case series about essential tremor (433 patients) achieved effective results similar to those discussed above. The available data of studies in other conditions examined are very few to draw firm conclusions. In any case, the results of the available case series are promising and indicate the need for further studies with larger samples and controlled clinical trials.

Authors' recommendations: From the perspective of efficacy / effectiveness and safety of DBS for the different conditions evaluated, the following recommendations are estabhised: - DBS is recommended for the treatment of AD in patients at an advanced stage, with symptoms not controlled by medication or complications from this. In the current state of knowledge on the evolution of long-term results, it is not possible to establish the relative superiority of STN DBS versus the GPi or vice versa. - Although there is evidence that the positive results of STN DBS are extensible to patients with early symptoms of the disease (aged around 50 years), longer-term studies are necessary that compare the results of this early intervention compared to those achieved in patients at an advanced stage. - In the case of primary dystonia (generalized or segmental), GPi DBS is recommended in patients refractory to medical therapy. The available evidence in the case of essential tremor allows the recommendation of thalamic DBS in patients refractory to medical therapy. - The DBS of the TAN is an option to consider in the treatment of epilepsy arising from the temporal regions in patients who have not responded to drug therapy. - There is insufficient evidence to recommend the use of DBS in secondary dystonia, tremor caused by multiple sclerosis, symptoms of Tourette syndrome or psychiatric disorders. - Implant surgery should be performed by expert teams so as to minimize the risk of AEs. Exploration of the psychological history of patients and a close monitoring of depressive symptoms after surgery is needed. - Taking into account the uncertainty about the long-term (over five years) of the improvements achieved, the need for reprogramming the stimulator to a possible loss of efficiency, and especially the likelihood of serious AEs requiring hospitalization, it is necessary to perform a riskbenefit balance in a context of informed and shared decision making with the patients and their family, depending on the clinical characteristics of the patient and the desired therapeutic goals.

Authors' methods: A systematic review (SR) of the scientific evidence on the efficacy, safety, effectiveness, and cost-effectiveness of DBS for the treatment of neurological and neuropsychiatric disorders was conducted. The following electronic databases were consulted: MEDLINE and PreMedline (1950-April 2013), EMBASE (1980- April 2013), PsycINFO (1887- April 2013), CINAHL (1982- April 2013), Cochrane Library (1982- April 2013), Centre for Reviews & Dissemination (1973- April 2013). This search strategy was complemented by manual bibliographic. Two reviewers performed the entire selection process of studies and in case of doubt or disagreement between them a third reviewer was consulted. We selected SR with meta-analysis (MA) and SR without MA in those cases where not prior MA was available in relation to a disease or an outcome of interest, considering also the subsequent randomized controlled trials not included in these SR and MA. We also considered economic evaluations (EE) and cost studies in Spain (CS). The study selection was limited to those published in English and Spanish. The methodological quality of included studies was assessed using the Oxman scale.

Project Status: Completed

Year Published: 2013

URL for published report: https://sescs.es/estimulacion-cerebral-profunda-en-trastornos-neurologicos-y-psiquiatricos/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es