- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07572526
tDCS: Sleep to Mood in Depression (S2M-D)
Sleep Consolidation as a Mechanistic Pathway Linking Home-Based tDCS to Antidepressant Response (S2M-D)
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This study evaluates the effects of home-based transcranial direct current stimulation (tDCS) on sleep and depressive symptoms in adults with moderate depression. tDCS is a noninvasive neuromodulation technique that delivers a mild electrical current to the scalp to modulate brain activity and has been studied as a potential treatment for depression.
Participants will self-administer tDCS for 20 sessions at home over the course of the study. Sleep will be continuously monitored using a wearable device called an Oura Ring that captures sleep measures such as sleep duration, efficiency, awakenings, and night-to-night consistency. Depressive symptoms will be assessed longitudinally using validated clinical and self-report measures.
The primary objective is to determine whether changes in sleep consolidation occur over the course of tDCS treatment. A secondary objective is to evaluate whether changes in sleep are temporally associated with improvements in depressive symptoms.
This study aims to better characterize the relationship between sleep and depressive response during tDCS, and to identify potential sleep-related markers associated with clinical improvement in depression.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Shayna Pehel
- Número de teléfono: 929-455-5104
- Correo electrónico: Shayna.Pehel@nyulangone.org
Copia de seguridad de contactos de estudio
- Nombre: Giuseppina Pilloni
- Número de teléfono: 929-455-5317
- Correo electrónico: Giuseppina.Pilloni@nyulangone.org
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10016
- Reclutamiento
- NYU Langone Health
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Ability to read and understand study materials in English, as demonstrated by a standard score >85 on the WRAT-5 Reading Recognition Subtest
- MADRS-S ≥18 during screening
- Confirmed diagnosis of MDD, based on clinician interview
- If taking antidepressant medication, the dose must be stable for at least 30 days prior to pre-screening.
- Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms OR confirmed acknowledgement and identification of local resources.
- Able to provide informed consent and comply with study procedures.
- Access to a quiet space suitable for home-based tDCS stimulation sessions.
Exclusion Criteria:
- Current major medical condition that, in the opinion of the study clinician, would interfere with study participation, safety, or interpretation of study outcomes.
- Current or past bipolar disorder, psychotic disorder, or current (past 6 months) alcohol or substance use disorder, as determined by clinician assessment at screening.
- Clinically significant suicidal ideation or behavior, based on clinician assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Use of prescription or over-the-counter sleep-promoting medications or initiation of behavioral interventions specifically targeting sleep in the past 30 days from pre-screening.
- History of seizure disorder or epilepsy.
- Presence of an active implanted medical device above the neck (e.g., deep brain stimulator, cochlear implant) or non-MRI-compatible metallic implants in the head or neck region.
- Current use of prescription or over-the-counter sleep medications, or active participation in any behavioral or pharmacologic treatment specifically targeting sleep.
- Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding o If able to become pregnant, participants will be required to use medically accepted birth control methods, including hormonal methods (e.g., pills, patches, implants), barrier methods (e.g., condoms or diaphragm with spermicide), intrauterine device (IUD), or abstinence. Participants will be advised not to become pregnant during the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Active transcranial direct current stimulation (tDCS)
Participants will complete a 20-session course of home-based left dorsolateral prefrontal cortex (DLPFC) transcranial direct current stimulation (tDCS) (2.0 mA, 30 minutes per session).
|
Transcranial direct current stimulation delivers a gentle, low-intensity electrical current.
The tDCS device is programmed to ramp up to 2.0 mA (for 30 seconds), deliver constant current throughout the session (29 minutes), and then ramp down (for 30 seconds) at the end of the session.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in sleep efficiency
Periodo de tiempo: Baseline, Post-Intervention (Week 5)
|
Sleep efficiency (SE) is the percentage of time spent asleep while in bed.
A healthy, normal efficiency is 85% or higher, with 90% or more considered very good.
Low efficiency can indicate poor sleep quality.
|
Baseline, Post-Intervention (Week 5)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in wake after sleep onset (WASO)
Periodo de tiempo: Baseline, Post-Intervention (Week 5)
|
WASO represents the sum of all wakefulness durations after sleep initiation.
|
Baseline, Post-Intervention (Week 5)
|
|
Change in night-to-night variability in sleep efficiency
Periodo de tiempo: Baseline, Post-Intervention (Week 5)
|
Night-to-night variability in sleep efficiency is measured as the percentage of time in bed actually spent sleeping.
High variability can indicate poor sleep quality.
|
Baseline, Post-Intervention (Week 5)
|
|
Change in total sleep time
Periodo de tiempo: Baseline, Post-Intervention (Week 5)
|
Baseline, Post-Intervention (Week 5)
|
|
|
Change in sleep latency
Periodo de tiempo: Baseline, Post-Intervention (Week 5)
|
Sleep latency is the time it takes to transition from full wakefulness to sleep.
An ideal sleep latency is typically 10-20 minutes.
|
Baseline, Post-Intervention (Week 5)
|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS-S) score
Periodo de tiempo: Baseline, Final Follow-Up Study Visit (Month 2)
|
MADRS-s is a 10-item self report questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
Each item is rated on a 0-6 scale, resulting in a total score range of 0-60.
The higher the score, the more severe the depression.
|
Baseline, Final Follow-Up Study Visit (Month 2)
|
|
Change in Patient Health Questionnaire-8 (PHQ-8) score
Periodo de tiempo: Baseline, Final Follow-Up Study Visit (Month 2)
|
The PHQ-8 consist of 8-items.
Participants self-report the severity of current depression.
Each item is scored 0-3 based on frequency (0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day), with a total score ranging from 0 to 24.
Higher scores indicate severe depression.
|
Baseline, Final Follow-Up Study Visit (Month 2)
|
|
Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) score
Periodo de tiempo: Baseline, Final Follow-Up Study Visit (Month 2)
|
The QIDS-SR is a 16-item self-report tool used to measure the severity of depressive symptoms.
Scores range from 0-27, with higher scores indicating clinically significant depression.
|
Baseline, Final Follow-Up Study Visit (Month 2)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Giuseppina Pilloni, NYU Langone Health
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Síntomas de comportamiento
- Trastornos del estado de ánimo
- Desorden depresivo
- Comportamiento
- Depresión
- Trastorno Depresivo Mayor
- Terapéutica
- Disciplinas y actividades de comportamiento
- Terapia de estimulación eléctrica
- Terapia convulsiva
- Terapias somáticas psiquiátricas
- Electrochoque
- Técnicas psicológicas
- Estimulación de corriente continua transcraneal
Otros números de identificación del estudio
- 26-00329
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .