RESUMO
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.
Assuntos
Transtorno Depressivo Maior/terapia , Transtorno Depressivo Resistente a Tratamento/terapia , Terapia por Estimulação Elétrica/métodos , Nervo Trigêmeo , Adulto , Doença Crônica/terapia , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos de Pesquisa , Resultado do TratamentoRESUMO
Objetivo: Avaliar o significado da evidência da isquemia miocárdica e a ocorrência de eventos cardiovasculares na Síndrome Cardíca X (SCX), comparando com doença coronária obstrutiva inicial (DAC <- 50 por cento). Métodos: Estudo observacional de coorte, em, amostra de 605 pacientes (população fonte de 5.137 indivíduos), com ecocardiografia sob estresse físico (EEF) positiva para isquemia miocárdica, os quais foram submetidos à cineangiocoronariografia, e divididos, posteriormente, em 2 grupos: G1 (SCX, n=64) e G2 (DAC<- 50 por cento, n=84). Os pacientes foram comparados quanto às características clínicas, parâmetros ergométricos e ecocardiográficos, e seguidos po +- 43,8 meses (mínimo de 12 meses e máximo de 85 meses), quanto ao surgimento de ngina típica, infarto agudo do miocárdico...
