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Neurosurgery ; 2018 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-30272245


BACKGROUND: More than 30% of major depressive disorder patients fail to respond to adequate trials of medications and psychotherapy. While modern neuromodulation approaches (ie, vagal nerve stimulation, deep brain stimulation) are yet to prove their efficacy for such cases in large randomized controlled trials, trigeminal nerve stimulation (TNS) has emerged as an alternative with promising effects on mood disorders. OBJECTIVE: To assess efficacy, safety, tolerability, and placebo effect duration of continuous subcutaneous TNS (sTNS) in treatment-resistant depression (TRD). METHODS: The TREND study is a single-center, double-blind, randomized, controlled, phase II clinical trial. Twenty unipolar TRD patients will receive V1 sTNS as adjuvant to medical therapy and randomized to active vs sham stimulation throughout a 24-wk period. An additional 24-wk open-label phase will follow. Data concerning efficacy, placebo response, relapse, and side effects related to surgery or electrical stimulation will be recorded. We will use the HDRS-17, BDI-SR, IDS_SR30, and UKU scales. EXPECTED OUTCOMES: The main outcome measure is improvement in depression scores using HAM-17 under continuous sTNS as adjuvant to antidepressants. Active stimulation is expected to significantly impact response and remission rates. Minor side effects are expected due to the surgical procedure and electrical stimulation. The open-label phase should further confirm efficacy and tolerability. DISCUSSION: This study protocol is designed to define efficacy of a novel adjuvant therapy for TRD. We must strive to develop safe, reproducible, predictable, and well-tolerated neuromodulation approaches for TRD patients impaired to manage their lives and contribute with society.

Neurosurgery ; 83(4): 800-809, 2018 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-29538761


BACKGROUND: Human morbid obesity is increasing worldwide in an alarming way. The hypothalamus is known to mediate its mechanisms. Deep brain stimulation (DBS) of the ventromedial hypothalamus (VMH) may be an alternative to treat patients refractory to standard medical and surgical therapies. OBJECTIVE: To assess the safety, identify possible side effects, and to optimize stimulation parameters of continuous VMH-DBS. Additionally, this study aims to determine if continuous VMH-DBS will lead to weight loss by causing changes in body composition, basal metabolism, or food intake control. METHODS: The BLESS study is a feasibility study, single-center open-label trial. Six patients (body mass index > 40) will undergo low-frequency VMH-DBS. Data concerning timing, duration, frequency, severity, causal relationships, and associated electrical stimulation patterns regarding side effects or weight changes will be recorded. EXPECTED OUTCOMES: We expect to demonstrate the safety, identify possible side effects, and to optimize electrophysiological parameters related to VMH-DBS. No clinical or behavioral adverse changes are expected. Weight loss ≥ 3% of the basal weight after 3 mo of electrical stimulation will be considered adequate. Changes in body composition and increase in basal metabolism are expected. The amount of food intake is likely to remain unchanged. DISCUSSION: The design of this study protocol is to define the safety of the procedure, the surgical parameters important for target localization, and additionally the safety of long-term stimulation of the VMH in morbidly obese patients. Novel neurosurgical approaches to treat metabolic and autonomic diseases can be developed based on the data made available by this investigation.

J Invasive Cardiol ; 20(8): 404-10, 2008 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-18688065


BACKGROUND: Despite the increasing number of elderly people, this high-complexity subset of patients is often excluded from randomized trials of percutaneous coronary intervention (PCI) and, therefore, limited data are available about their outcomes after drug-eluting stent (DES) implantation. We sought to compare the very long-term (> 1 year) clinical follow up of octogenarians treated with DES compared to younger individuals. METHODS: The DESIRE registry is a prospective, nonrandomized, single-center registry with consecutive patients treated solely with DES between May 2002 and May 2007. The only exclusion criteria were the treatment of patients in the setting of acute myocardial infarction (MI) (< 72 hours) and lesions located in non-native coronary arteries. The primary endpoint was the occurrence of combined major adverse cardiac events (MACE) (cardiac death, non-fatal MI and target vessel revascularization) in-hospital and in very long term (> 1 year) follow up. Patients were clinically evaluated at 1, 3 and 6 months and then annually up to 5 years. Stent thrombosis was classified according to the ARC definition. RESULTS: A total of 1,364 patients matched the inclusion/exclusion criteria and were sorted into 3 groups according to their ages: Group I = patients < 70 years of age (n = 914); Group II = patients greater than or equal to 70 and < 80 years of age (n = 334); and Group III = patients greater than or equal to 80 years old (n = 116). As expected, octogenarians had significantly more comorbid and complex anatomic lesion presentation. Nevertheless, in-hospital success was comparable among the 3 groups. Long-term (2.6 +/- 1.2 years) follow up was obtained from 97% of the total population and showed equivalent cumulative MACE in all age ranges (7.6% for < 70 years old vs. 5.4% for septuagenarians and 6.0% for octogenarians, p = 0.7). However, octogenarians had markedly more cardiac death, reflecting the severity of their comorbidity and the natural evolution of coronary disease. Of note, very few cases of stent thrombosis were noticed in the overall population (20 patients, 1.5%), with no difference among the groups. CONCLUSIONS: PCI with DES represents an efficient and safe approach to treat coronary artery disease in the elderly, with low rates of combined MACE comparable to other age ranges.

Angioplastia Coronária com Balão/efeitos adversos , Estenose Coronária/terapia , Stents Farmacológicos/efeitos adversos , Isquemia Miocárdica/terapia , Sistema de Registros , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/mortalidade , Feminino , Fibrinolíticos/uso terapêutico , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento
Rev. bras. cardiol. invasiva ; 16(2): 144-154, abr.-jun. 2008. graf, tab
Artigo em Português | LILACS | ID: lil-498767


Fundamentos: Reportamos a incidência e os preditores de trombose de stent numa grande coorte de pacientes complexos tratados com stents farmacológicos (SF) no "mundo real", Métodos: Entre maio de 2002 e janeiro de 2008, 2.365 pacientes não selecionados com maior ou menor lesão coronária com estenose maior ou menor 50 por cento tratados com ST. O seguimento clínico até cinco anos (média 2,2 mais ou menos 1,5 anos) foi completado em 98,3 por cento. Resultados: Entre os pacientes avaliados 29 por cento tinham diabetes, 60 por cento eram portadores de doença multiarterial e 40 por cento apresentavam síndrome coronária aguda (15 por cento, infarto agudo do miocárdio [IAM]). A artéria descendente anterior foi o vaso-alvo mais frequentemente tratado (35,8 por cento) e 67 por cento das lesões eram de alta complexidade (tipo B2/C). No total, 3.634 SF foram implantados e 40 por cento dos pacientes receberam múltiplos stents. A trombose de stent (classificação Academic Research Consortium) incidiu em 1,6 por cento (n igual 38), 60,5 por cento com confirmação angiográfica...

Humanos , Masculino , Pessoa de Meia-Idade , Angioplastia Coronária com Balão , Trombose/complicações , Stents