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- Ensaio Clínico NCT06236711
Estimulação transcraniana por corrente contínua (tDCS) como tratamento adjuvante para depressão resistente ao tratamento (TRD)
Um estudo de viabilidade da estimulação transcraniana por corrente contínua (tDCS) como tratamento adjuvante para depressão resistente ao tratamento (TRD) em pacientes hospitalizados
The researchers are trying to test the feasibility and acceptability of using transcranial Direct Current Stimulation (tDCS) in hospitalized adult patients with Treatment Resistant Depression (TRD), assess for any preliminary effect on depressive and cognitive symptoms, and explore the utility of biomarkers to assess response to tDCS.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
In this feasibility study the researchers propose to conduct a 5-day tDCS treatment protocol in hospitalized adult patients with TRD, with each treatment session lasting for 30 minutes, delivered twice daily, for a total of 10 stimulations over 5 days. Before and after the 5-day tDCS treatment protocol, assessments will include Montgomery-Asberg Depression Rating Scale (MADRS) to measure depressive symptoms, Snaith-Hamilton Pleasure Scale (SHAPS) to measure anhedonia, Stroop Test to measure memory and executive function, Revised Hopkins Verbal Learning Test (HVLT-R) to test verbal learning and memory, and Digital Symbol Coding Test (DSCT) to measure working memory. Electroencephalography (EEG) for objective electrophysiologic data will also be collected before and after tDCS. A wireless EEG unit (CGX, Cognionic, Inc.) will be used to collect EEG and peak alpha frequency (PAF) as potential target engagement marker for tDCS. The PAF measures the highest magnitude within the alpha range of brain oscillations, thought to reflect cognitive performance. Other potential predictors of treatment response measures collected at baseline include Adverse Childhood Experiences (ACE), premorbid intelligence quotient (pIQ), Wide Range Achievement Reading Test (WRART), and Socioeconomic Status (SES).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic in Rochester
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria
- 18 years and older
- Clinical diagnosis of treatment-resistant depression (defined as depression that does not remit following two or more treatment attempts of an adequate dose and duration of a minimum duration of 4 weeks)
- Hospitalized in psychiatric units
- Voluntary admission status
- Moderate or severe depression, defined by PHQ-9 ≥ 15
- Ability to provide informed consent
- Ability to adhere to protocol
Exclusion Criteria
- Bipolar disorder
- Active primary psychotic or substance use disorders (except nicotine dependence) within the past year
- Any active neurological condition (including seizure disorder, traumatic brain injury, stroke)
- Contraindications to tDCS (including pacemaker, metallic implants in the head or neck [except orthodontic hardware], skin disease causing irritation)
- Current pregnancy or positive urine pregnancy test (clinical)
- Any neuromodulation therapy (including ECT, rTMS, DBS, VNS, TES) within the last 3 months
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Viabilidade do dispositivo
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: tDCS interventional arm
Participants will receive a 30-minute tDCS treatments at 2 mA twice daily over the course of 5 days. |
tDCS is a form of noninvasive transcranial stimulation of the brain by delivering low-intensity electrical current to the scalp through two electrodes. The Soterix Medical 1×1 Low Intensity Transcranial DC Stimulator Model 1300A (Soterix Medical, Inc., New York, NY, USA) device will be used in the study. The tDCS device is comprised of a small battery-operated control box that delivers the current through electrodes placed on the scalp, held in place by elastic bands or head straps and worn over the forehead like a headband. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility outcome
Prazo: through study completion, an average of 2 weeks
|
Defined as 70% of eligible patients choosing to enroll in the study. Other feasibility parameters will include willingness of clinicians to refer and help recruit patients, number of eligible participants, willingness of participants to enroll, retention of patients, and completeness of data collection. |
through study completion, an average of 2 weeks
|
|
Acceptability outcome
Prazo: through study completion, an average of 2 weeks
|
Defined as 80% of study participants completing 80% of the 10-session tDCS treatment protocol. Investigators will also ask participants about their satisfaction, perceptions, and experiences with the tDCS treatments. Other acceptability parameters will include rates of adherence to tDCS protocol, dropout rates and reasons for non-completion. |
through study completion, an average of 2 weeks
|
|
Tolerability outcome
Prazo: through study completion, an average of 2 weeks
|
Defined as an overall tolerability rating of "very tolerable." This will be a self-report based on a global question "Considering all aspects of your experience, how would you rate the overall tolerability of the tDCS intervention?" The response options are: very tolerable, somewhat tolerable, neutral, somewhat intolerable, and very intolerable. Other tolerability parameters will include the tDCS adverse effects questionnaire. |
through study completion, an average of 2 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Prazo: baseline, 2 weeks
|
Measure of depressive symptoms. Response is defined by a 50% or more reduction in MADRS score. The MADRS has 10-items which are based on mood symptoms. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression). |
baseline, 2 weeks
|
|
Change in Snaith-Hamilton Pleasure Scale (SHAPS)
Prazo: baseline, 2 weeks
|
Measure of anhedonia. The SHAPS has 14-items which are based on pleasure symptoms. Each item is scored 1 (definitely agree) to 4 (definitely disagree) with overall score ranges from 14 (experience high pleasure) to 56 (experience low pleasure) |
baseline, 2 weeks
|
|
Change in Stroop Test
Prazo: baseline, 2 weeks
|
Measure of measure memory and executive function. Reaction time (in seconds) in the different conditions of the task (reading the non-conflicting condition, reading the conflicting condition) |
baseline, 2 weeks
|
|
Change in Revised Hopkins Verbal Learning Test (HVLT-R)
Prazo: baseline, 2 weeks
|
Measure of verbal learning and memory. The HVLT-R has 12-items which are based on memory score. Total recall score (range from 0 to 36). The higher the score indicates better short-term memory, lowers scores indicates worse short-term memory. |
baseline, 2 weeks
|
|
Change in Digital Symbol Coding Test (DSCT)
Prazo: baseline, 2 weeks
|
Measure of working memory. The DSST involves a key consisting of the numbers 1-9, each paired with a unique, easy to draw symbol. Below the key are a series of numbers that 1-9 in random order and repeated several times, that are to be filled in the corresponding symbol for each number. One point is given for each correct response. Total scores range from 0-9, lower scores indicate worse memory; higher scores indicate better memory. |
baseline, 2 weeks
|
|
Change in Peak alpha frequency (PAF)
Prazo: baseline, 2 weeks
|
EEG measure of the highest magnitude within the alpha range of brain oscillations, thought to reflect cognitive performance. |
baseline, 2 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Maria I Lapid, MD, Mayo Clinic
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Transtornos de Humor
- Desordem depressiva
- Transtorno Depressivo Resistente ao Tratamento
- Terapêutica
- Disciplinas e atividades comportamentais
- Terapia de estimulação elétrica
- Terapia convulsiva
- Terapias somáticas psiquiátricas
- ElectroShock
- Técnicas psicológicas
- Estimulação de corrente direta transcraniana
Outros números de identificação do estudo
- 23-003274
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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