Temporal Interference Transcranial Alternating Current Stimulation for Major Depressive Disorder
6 de septiembre de 2026 actualizado por: Yumeng Ju, Central South University
A Double-Blind, Randomized, Sham-Controlled Clinical Trial of Temporal Interference Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder
This multi-center, double-blind study, randomized controlled trial aims to evaluate the efficacy and safety of Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) in patients with major depressive disorder (MDD)
Participants with major depressive disorder will be randomized to receive high-frequency TI-tACS(130 Hz), low-frequency TI-tACS(2Hz), or sham stimulation targeting the right amygdala.
The intervention consists of 20 stimulation sessions administered over 2 weeks (twice a day for 5 consecutive days, followed by a 2-day break, and another 5 consecutive days). Clinical assessments will be conducted at baseline, during treatment, and at multiple follow-up time points up to 6 months.
The primary outcome for MDD is the change from baseline in the Hamilton Depression Rating Scale (HAMD-17) at week 2. Secondary outcomes include changes in clinical symptoms, cognitive function, and safety profiles.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
Major depressive disorder (MDD) is a highly prevalent psychiatric disorder associated with substantial disability and impaired quality of life. Neuroimaging studies have demonstrated abnormalities in distributed cortical-subcortical circuits, particularly involving the amygdala, which plays a central role in emotional processing and symptom regulation. Although several neuromodulation techniques have shown therapeutic potential, currently available approaches have limited ability to selectively modulate deep brain structures without invasive procedures.
Temporal interference transcranial alternating current stimulation (TI-tACS) is a novel non-invasive neuromodulation technique that delivers two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope within deep brain regions. This approach enables selective modulation of deep neural structures, such as the amygdala, while minimizing stimulation of the overlying cortex.
This is a multicenter, randomized, triple-blind, sham-controlled clinical trial designed to evaluate the efficacy, safety, and neurobiological mechanisms of TI-tACS in participants with MDD. Participants will be enrolled randomized to receive active or sham TI-tACS according to the study protocol.
Approximately 102 participants will be recruited. Following written informed consent, participants will undergo baseline assessments and subsequent study evaluations according to the protocol. Study assessments include clinical evaluations, neurocognitive testing, electroencephalography (EEG), magnetic resonance imaging (MRI), and biological sample collection. TI-tACS treatment consists of 20 stimulation sessions administered over two weeks (two sessions per day for five consecutive days, followed by a two-day break, and another five consecutive treatment days).
Participants will also complete scheduled post-treatment follow-up assessments to evaluate the persistence of treatment effects and the long-term safety of TI-tACS.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
102
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yumeng Ju( Associate Researcher), PhD
- Número de teléfono: 86+18100731091
- Correo electrónico: yumeng.ju@csu.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: Lingsi Zeng, PhD Candidate
- Correo electrónico: zenglsi@163.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age between 18 and 55 years (inclusive), any gender;
- Diagnosis of a single or recurrent episode of Major Depressive Disorder (MDD) according to DSM-5 criteria, assessed by trained researchers using the Structured Clinical Interview for DSM-5 (SCID), without psychotic features;
- HAMD-17 score ≥14; inadequate response to stable, regular antidepressant medication for at least 1 month at an adequate dose;
- Education level: junior high school or above; adequate cognitive and language ability to understand and complete study assessments;
- Voluntary participation with signed informed consent; ability to comply with study visits, treatment schedules, laboratory tests, and other study procedures.
Exclusion Criteria:
- History of psychiatric disorders other than MDD;
- Pregnancy or lactation;
- Neurologic disorders or serious systemic diseases (e.g., thyroid disease, lupus erythematosus, diabetes, hepatic or renal impairment, active infection, major trauma);
- History of significant head injury or coma
- Receipt of physical therapies such as electroconvulsive therapy or rTMS within the past six months before enrollment
- Suspected or confirmed history of alcohol or substance dependence;
- Current severe suicidal ideation or recent suicide attempt;
- Current participation in another clinical trial or recent use of prohibited psychotropic medications;
- Positive urine drug screening or abnormal thyroid function tests;
- Contraindications to magnetic resonance imaging (MRI) or electroencephalography (EEG);
- Inability to provide fully informed consent.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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: High-frequency TI-tACS
Participants in the High-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (130Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala.
The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
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Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) is a non-invasive neuromodulation technique that generates a low-frequency （130HZ or 2HZ) envelope field in deep brain regions, particularly the right amygdala, through the interaction of two high-frequency currents.
Otros nombres:
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Experimental: Low-frequency TI-tACS
Participants in the Low-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (2 Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala.
The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
|
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) is a non-invasive neuromodulation technique that generates a low-frequency （130HZ or 2HZ) envelope field in deep brain regions, particularly the right amygdala, through the interaction of two high-frequency currents.
Otros nombres:
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Comparador falso: Sham TI-tACS
Participants in the Sham TI-tACS group receive 20-minute sham stimulation of the same device twice a day for 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
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Sham Temporal Interference transcranial Alternating Current Stimulation will mimic the sensory experience of active stimulation without delivering effective current.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in the Hamilton Depression Rating Scale(HAMD-17) scores at week 2.
Periodo de tiempo: 2 weeks(from baseline)
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The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-administered instrument used to assess the severity of depressive symptoms.
The scale consists of 17 items with a total score ranging from 0 to 52.
Higher scores indicate more severe depressive symptoms.
The primary outcome for MDD participants will be calculated as the change in HAMD-17 score from baseline to Week 2.
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2 weeks(from baseline)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Periodo de tiempo: Baseline to month 2 follow-up(post treatment)
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A 7-item self-report questionnaire used to assess the severity of generalized anxiety symptoms.
Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.
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Baseline to month 2 follow-up(post treatment)
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Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score
Periodo de tiempo: Baseline to month 2 follow-up
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The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered instrument used to assess the severity of depressive symptoms and sensitivity to treatment-related changes.
The scale consists of 10 items with a total score ranging from 0 to 60. Higher scores indicate more severe depressive symptoms.
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Baseline to month 2 follow-up
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Adverse Events Related to treatment
Periodo de tiempo: Baseline to month 2 follow-up
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Incidence, type, and severity of adverse events related to the transcranial temporal interference stimulation, assessed using a standardized Neuromodulation Adverse Effects Questionnaire.
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Baseline to month 2 follow-up
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Change in Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: Baseline to month 2 follow-up
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A 9-item self-report questionnaire used to assess depressive symptom severity.
Total scores range from 0 to 27, with higher scores indicating greater depression severity.
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Baseline to month 2 follow-up
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Change in the Hamilton Anxiety Rating Scale (HAMA) Score
Periodo de tiempo: Baseline to month 2 follow-up
|
The Hamilton Depression Rating Scale-17 (HAMD-17) is a 17-item clinician-administered scale used to assess the severity of depressive symptoms.
The total score ranges from 0 to 52, with higher scores indicating more severe depressive symptoms.
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Baseline to month 2 follow-up
|
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Change in Young Mania Rating Scale (YMRS) Score
Periodo de tiempo: Baseline to month 2 follow-up
|
The Young Mania Rating Scale (YMRS) is an 11-item clinician-administered instrument used to assess the severity of manic symptoms and to monitor treatment-emergent mania or hypomania.
Total scores range from 0 to 60, with higher scores indicating more severe manic symptoms.
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Baseline to month 2 follow-up
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Change in Pittsburgh Sleep Quality Index (PSQI) Score
Periodo de tiempo: Baseline to month 2 follow-up
|
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire used to assess subjective sleep quality and sleep disturbances over the previous month.
The questionnaire generates a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
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Baseline to month 2 follow-up
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Change in Beck Scale for Suicide Ideation (BSI) Score
Periodo de tiempo: Baseline to month 2 follow-up
|
The Beck Scale for Suicide Ideation (BSI) is a 19-item clinician-administered instrument used to assess the severity of suicidal thoughts, attitudes, and intentions.
Total scores range from 0 to 38, with higher scores indicating more severe suicidal ideation.
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Baseline to month 2 follow-up
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hange in 10-item Connor-Davidson Resilience Scale (CD-RISC-10) Score
Periodo de tiempo: Baseline to month 2 follow-up
|
The 10-item Connor-Davidson Resilience Scale (CD-RISC-10) is a 10-item self-report questionnaire used to assess psychological resilience and the ability to cope with adversity.
Total scores range from 0 to 40, with higher scores indicating greater psychological resilience.
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Baseline to month 2 follow-up
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Change in Chinese Version of the Cognitive Emotion Regulation Questionnaire (CERQ-C) Score
Periodo de tiempo: Baseline to month 2 follow-up
|
The Chinese Version of the Cognitive Emotion Regulation Questionnaire (CERQ-C) is a 36-item self-report questionnaire used to assess cognitive emotion regulation strategies in response to stressful or negative life events.
Total scores range from 36 to 180, with higher scores indicating greater use of cognitive emotion regulation strategies.
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Baseline to month 2 follow-up
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Change in State Anxiety Inventory (S-AI) Score
Periodo de tiempo: Baseline to month 2 follow-up
|
The State Anxiety Inventory (S-AI) is a 20-item self-report questionnaire used to assess transient anxiety experienced at the time of assessment.
Total scores range from 20 to 80, with higher scores indicating greater state anxiety.
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Baseline to month 2 follow-up
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Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Score
Periodo de tiempo: Baseline to month 2 follow-up
|
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a 17-item clinician-administered instrument used to assess the severity of depressive symptoms.
Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms.
|
Baseline to month 2 follow-up
|
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Change in Sheehan Disability Scale (SDS) Score
Periodo de tiempo: Baseline to month 2 follow-up
|
he Sheehan Disability Scale (SDS) is a 3-item self-report questionnaire used to assess functional impairment in work/school, social life, and family life/home responsibilities.
Total scores range from 0 to 30, with higher scores indicating greater functional impairment.
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Baseline to month 2 follow-up
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Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score
Periodo de tiempo: Baseline to month 2 follow-up
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The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item self-report questionnaire used to assess anhedonia, or the ability to experience pleasure.
Total scores range from 14 to 56, with higher scores indicating greater anhedonia (reduced ability to experience pleasure).
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Baseline to month 2 follow-up
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Change in Ruminative Responses Scale (RRS) Score
Periodo de tiempo: Baseline to month 2 follow-up
|
The Ruminative Responses Scale (RRS) is a 22-item self-report questionnaire used to assess the tendency to engage in repetitive negative thinking in response to depressed mood or distress.
Total scores range from 22 to 88, with higher scores indicating greater rumination.
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Baseline to month 2 follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Yan Zhang, PhD, Second Xiangya Hospital of Central South University
- Investigador principal: Yumeng Ju, PhD, Second Xiangya Hospital of Central South University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de septiembre de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
16 de julio de 2026
Publicado por primera vez (Actual)
17 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LYG20240121
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared because the dataset includes sensitive neuroimaging and biological data that may compromise participant confidentiality.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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