Individualized Temporally Interfering Electrical Stimulation in Major Depressive Disorder
Closed-Loop Bio-Machine Interaction System and Applications in Psychiatric Diagnosis and Treatment
Temporally interfering (TI) electrical stimulation is a novel noninvasive neuromodulation technique with high spatial resolution. Although its effects on human brain function and behavior have been increasingly investigated, its clinical utility in major depressive disorder (MDD) has not been established. This trial aims to evaluate the efficacy and safety of TI electrical stimulation in MDD patients.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This is a multicenter, double-blind, randomized, sham-controlled trial including three parallel arms: (1)single-target active stimulation targeting the right primary auditory cortex (A1); (2) dual-target active stimulation targeting the right A1 and the right dorsolateral prefrontal cortex (DLPFC); (3)sham stimulation. All interventions will be delivered over two consecutive weeks, comprising ten treatment visits, with 20 minutes of stimulation applied to each target.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Xianyun Kang
- Número de teléfono: +862283612122
- Correo electrónico: xianyunkang@tju.edu.cn
Ubicaciones de estudio
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Fujian
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Fuzhou, Fujian, Porcelana, 350007
- Reclutamiento
- Fuzhou Neuropsychiatric Hospital Affiliated to Fujian Medical University
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Contacto:
- Renchun Huang
- Número de teléfono: +8659163069948
- Correo electrónico: 810538265@qq.com
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 300222
- Reclutamiento
- Tianjin Anding Hospital
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Contacto:
- Shen Li
- Número de teléfono: +862288188875
- Correo electrónico: lishen@tmu.edu.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for MDD, confirmed independently by two psychiatrists;
- Currently experiencing a depressive episode;
- Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 17;
- Aged between 18-65 years;
- No restrictions on sex or gender;
- Attained at least junior high school education; lower education permitted if cognitive capacity is confirmed by a physician;
- Normal or corrected-to-normal vision and normal hearing;
- No use of antidepressant within two weeks prior to enrollment, or ongoing antidepressant treatment judged by a psychiatrist to be in a stable treatment phase;
- Ability to read and understand informed consent and self-report assessment scales;
- Willingness to participate in the study, with written informed consent provided by the participant or a legal guardian.
Exclusion Criteria:
- History of any psychiatric disorder other than MDD;
- History of traumatic brain injury or coma;
- History of organic brain disease or severe systemic medical illness;
- History of cochlear implants, pacemakers, or other implanted brain devices;
- History of epileptic seizures or family history of epilepsy;
- Obvious suicidal or impulsive violent behavior;
- Receipt of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other neuromodulation therapies within the past six months;
- History of alcohol use disorder or use of other psychoactive substances;
- Participation in other interventional clinical trials;
- Any condition precluding informed consent or compliance with study procedures.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: single-target active TI electrical stimulation group
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Single-target active stimulation targeting the right primary auditory cortex (A1), each target stimulation phase will last 20 minutes, including a 30-second ramp-up at onset and a 30-second ramp-down at termination. Alternating currents with frequencies of f1 = 2000 Hz and f2 = 2040 Hz will be delivered through the two electrode pairs, and the total current intensity across the two electrode pairs will be fixed at 4 mA (AC, peak-to-base). The intervention will be administered over two consecutive weeks, with participants receiving stimulation on five days per week. |
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Experimental: dual-target active TI electrical stimulation group
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Dual-target active stimulation targeting the right A1 and the right dorsolateral prefrontal cortex (DLPFC), each target stimulation phase will last 20 minutes, including a 30-second ramp-up at onset and a 30-second ramp-down at termination. For each target, two pairs of electrodes will be used; the alternating current frequency and total stimulation intensity will be the same as those in the single-target active TI electrical stimulation group.The intervention will be administered over two consecutive weeks, with participants receiving stimulation on five days per week. |
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Comparador falso: sham TI electrical stimulation group
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Sham TI electrical stimulation group will follow the same session duration, treatment frequency, and procedural setup as the active stimulation groups. However, electrical stimulation will be limited to an initial 30-second ramp-up followed immediately by a 30-second ramp-down, after which no current will be delivered for the remainder of the session. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hamilton Depression Rating Scale 17-item (HAMD-17)
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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Total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity (worse outcomes). |
Baseline, Week 1, Week 2, Week 4.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity (worse outcomes). |
Baseline, Week 1, Week 2, Week 4.
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Hamilton Anxiety Rating Scale (HAMA)
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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Total scores range from 0 to 56, with higher scores indicating greater anxiety symptom severity (worse outcomes). |
Baseline, Week 1, Week 2, Week 4.
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Generalized Anxiety Disorder 7-item (GAD-7)
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity (worse outcomes). |
Baseline, Week 1, Week 2, Week 4.
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Young Mania Rating Scale (YMRS)
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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Total scores range from 0 to 60, with higher scores indicating greater manic symptom severity (worse outcomes). |
Baseline, Week 1, Week 2, Week 4.
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Electroencephalographic (EEG) Power in the Gamma Frequency Band
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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Gamma-band EEG power will be assessed using spectral analysis of EEG recordings. |
Baseline, Week 1, Week 2, Week 4.
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40-Hz Auditory Steady-State Response (ASSR) Event-Related Spectral Perturbation (ERSP)
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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The 40-Hz ASSR will be assessed using electroencephalography (EEG). Event-related spectral perturbation (ERSP) quantifies stimulus-induced changes in oscillatory power relative to a prestimulus baseline. ERSP will be expressed in decibels (dB), with higher values indicating greater stimulus-related power enhancement. |
Baseline, Week 1, Week 2, Week 4.
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40-Hz Auditory Steady-State Response (ASSR) Inter-Trial Coherence (ITC)
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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The 40-Hz ASSR will be assessed using electroencephalography (EEG). Inter-trial coherence (ITC) quantifies the consistency of oscillatory phase across repeated auditory stimulus presentations. ITC values range from 0 to 1, with higher values indicating greater phase consistency. |
Baseline, Week 1, Week 2, Week 4.
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Magnetic Resonance Imaging (MRI)
Periodo de tiempo: Baseline, Week 2.
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Changes in brain structure and functional organization, assessed using MRI, will be included as secondary neuroimaging outcomes. |
Baseline, Week 2.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Athens Insomnia Scale (AIS)
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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Total scores range from 0 to 24, with higher scores indicating greater insomnia symptom severity (worse outcomes). |
Baseline, Week 1, Week 2, Week 4.
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Attention Control Scale (ACS)
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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The ACS consists of 20 items assessing two dimensions of attentional control: Attentional Focusing and Attentional Shifting. Total scores range from 20 to 80, with higher scores indicating better overall attentional control abilities (better outcomes). Attentional Focusing reflects the ability to maintain attention and resist distractions, whereas Attentional Shifting reflects the ability to flexibly shift attention between tasks or stimuli. |
Baseline, Week 1, Week 2, Week 4.
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Chinese 10-item Rumination Response Scale (RRS-10)
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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The RRS-10 consists of 10 items assessing two dimensions of rumination: Brooding and Reflection, each comprising five items. Total scores range from 10 to 40, with higher scores indicating greater overall rumination (generally worse outcomes). Brooding reflects maladaptive rumination, whereas Reflection reflects purposeful self-focused thinking and does not necessarily indicate worse outcomes. |
Baseline, Week 1, Week 2, Week 4.
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Emotion Regulation Questionnaire (ERQ) - Cognitive Reappraisal Subscale
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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The Cognitive Reappraisal subscale of the ERQ consists of 6 items assessing the tendency to regulate emotions by reinterpreting emotional situations. Total scores range from 6 to 42, with higher scores indicating greater use of cognitive reappraisal, generally considered a more adaptive emotion regulation strategy (better outcomes). |
Baseline, Week 1, Week 2, Week 4.
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Emotion Regulation Questionnaire (ERQ) - Expressive Suppression Subscale
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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The Expressive Suppression subscale of the ERQ consists of 4 items assessing the tendency to inhibit outward emotional expression. Total scores range from 4 to 28, with higher scores indicating greater use of expressive suppression, generally considered a less adaptive emotion regulation strategy (worse outcomes). |
Baseline, Week 1, Week 2, Week 4.
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Cognitive Flexibility Inventory (CFI)
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4.
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The CFI consists of 20 items assessing two dimensions of cognitive flexibility: Alternatives (13 items) and Control (7 items). Total scores range from 20 to 100, with higher scores indicating greater cognitive flexibility (better outcomes). Alternatives reflects the ability to generate multiple explanations and solutions to difficult situations, whereas Control reflects the tendency to perceive difficult situations as controllable. |
Baseline, Week 1, Week 2, Week 4.
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Colaboradores e Investigadores
Fechas de registro del estudio
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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
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- XY1895
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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