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Individualized Temporal Interference Stimulation for Reward Processing in Late-Life Depression

3 de noviembre de 2026 actualizado por: Xiang Yang Zhang, Beijing HuiLongGuan Hospital

Neural Mechanisms Underlying the Modulation of Reward Processing by Individualized Temporal Interference Stimulation Targeting the Nucleus Accumbens in Late-Life Depression

This study aims to investigate the effects and neural mechanisms of individualized temporal interference stimulation (TI) targeting the left nucleus accumbens in older adults with depression. A total of 70 participants aged 60-80 years will be randomly assigned to receive active TI or sham stimulation. Clinical and cognitive assessments, a probabilistic reversal learning (PRL) task, MRI, and TMS-EEG will be used to evaluate changes in depressive symptoms, reward processing, and brain activity. Clinical and cognitive follow-up assessments will be conducted at 1 and 4 weeks after the intervention.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a randomized, double-blind, sham-controlled, parallel-group study involving 70 adults aged 60-80 years who meet DSM-5 criteria for a current episode of major depressive disorder and have at least moderate depressive symptoms.

Participants will be randomly assigned in a 1:1 ratio to an active TI group (n=35) or a sham stimulation group (n=35). Individualized TI will target the left nucleus accumbens, with stimulation administered for approximately 20 minutes per session, twice daily for five consecutive days (10 sessions in total).

Clinical and neuropsychological assessments will evaluate depressive symptoms, anxiety, anhedonia, sleep, and cognitive function. A probabilistic reversal learning (PRL) task will assess reward learning and cognitive flexibility. Structural MRI will support individualized stimulation planning, while resting-state functional MRI (rs-fMRI) and TMS-EEG will be used to investigate changes in brain networks and neurophysiological activity.

Assessments will be conducted at baseline and after the intervention, with additional follow-ups at 1 and 4 weeks. The study will compare changes between groups and explore associations among clinical outcomes, reward processing, and neural measures.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

70

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: Dongmei Wang, Ph.D
  • Número de teléfono: +86 132 4190 1959
  • Correo electrónico: wangdm@psych.ac.cn

Ubicaciones de estudio

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

60 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Aged 60-80 years.
  • Meet the DSM-5 diagnostic criteria for a current episode of major depressive disorder (MDD).
  • Have at least moderate depressive symptoms.
  • Able to understand and comply with study procedures, provide written informed consent, and voluntarily participate in the study.

Exclusion Criteria:

  • History of severe neurological disorders or epilepsy.
  • Severe or unstable medical conditions.
  • Contraindications to MRI, transcranial magnetic stimulation (TMS), or transcranial electrical stimulation.
  • Comorbid severe psychiatric disorders, such as bipolar disorder or schizophrenia.
  • Significant cognitive impairment that interferes with informed consent or completion of study procedures.
  • High suicide risk.
  • Any other medical or safety condition that, in the investigator's judgment, makes participation inappropriate.

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
Experimental: Active Temporal Interference Stimulation

Participants will receive individualized active temporal interference stimulation (TI) targeting the left nucleus accumbens, for 20 minutes per session, twice daily for five consecutive days (10 sessions in total).
Dispositivo: Active Temporal Interference Stimulation

Individualized active temporal interference stimulation (TI) targeting the left nucleus accumbens, delivered for 20 minutes per session, twice daily for five consecutive days (10 sessions in total).
Comparador falso: Sham Temporal Interference Stimulation

Participants will receive sham temporal interference stimulation (TI) with similar electrode placement and procedures, following the same schedule as the active group (10 sessions over five days).
Dispositivo: Sham Temporal Interference Stimulation

Sham temporal interference stimulation (TI) with similar electrode placement and procedures, without sustained effective stimulation, following the same schedule as the active group (10 sessions over five days).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Hamilton Depression Rating Scale (HAMD-24)
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

The 24-item Hamilton Depression Rating Scale (HAMD-24) assesses depressive symptom severity. Total scores range from 0 to 76, with higher scores indicating more severe depressive symptoms.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Snaith-Hamilton Pleasure Scale (SHAPS)
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Anhedonia will be assessed using the 14-item Snaith-Hamilton Pleasure Scale (SHAPS). Total scores range from 14 to 56, with higher scores indicating more severe anhedonia. Changes from baseline will be compared between groups.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Probabilistic Reversal Learning (PRL) Task
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

The PRL task assesses reward-based learning and cognitive flexibility. Participants learn from probabilistic feedback and adjust their choices when reward contingencies change. Task performance will be evaluated using behavioral measures of reward learning and reversal learning.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Hamilton Anxiety Rating Scale (HAMA)
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Anxiety severity will be assessed using the 14-item HAMA. Total scores range from 0 to 56, with higher scores indicating more severe anxiety.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disturbances. The global score, calculated from seven components, ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Mini-Mental State Examination (MMSE)
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Global cognitive function will be assessed using the MMSE. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Auditory Verbal Learning Test (AVLT) Performance
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Verbal learning and memory will be evaluated using the numbers of correctly recalled words during immediate recall, delayed recall, category-cued recall, and recognition testing.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Verbal Fluency Test (VF) Performance
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Verbal fluency will be assessed using the numbers of valid responses generated during animal naming, phonemic word generation, and action fluency tasks, each lasting one minute.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
3D Confusion Assessment Method (3D-CAM)
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Delirium will be assessed using the 3-Minute Diagnostic Interview for CAM-Defined Delirium (3D-CAM). The outcome will be recorded as the presence or absence of delirium.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Clock Drawing Test (CDT)
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Visuospatial and executive functioning will be assessed using a four-point Clock Drawing Test. Scores range from 0 to 4, with higher scores indicating better performance.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Digit Span Test (DST) Performance
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Attention and working memory will be assessed using forward and backward digit span, including maximum correctly recalled span length and the number of correct sequences.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Trail Making Test (TMT)
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Processing speed, attention, and executive functioning will be evaluated using completion time in seconds across the four TMT conditions in the study protocol. Errors will also be recorded.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Neuropsychiatric Inventory (NPI)
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

The 12-domain Neuropsychiatric Inventory (NPI) assesses neuropsychiatric symptoms. The total score is calculated by summing frequency × severity scores across 12 domains and ranges from 0 to 144, with higher scores indicating more severe symptoms.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Activities of Daily Living (ADL)
Periodo de tiempo: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Daily functioning will be assessed using the 20-item ADL scale. Scores range from 20 to 80, with higher scores indicating greater functional impairment.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Resting-State fMRI Brain Network Measures
Periodo de tiempo: Baseline, immediately after the intervention

Resting-state fMRI will be used to evaluate changes in nucleus accumbens-related functional connectivity and brain network characteristics following the intervention.
Baseline, immediately after the intervention
TMS-Evoked Global Mean Field Amplitude (GMFA)
Periodo de tiempo: Baseline, immediately after the intervention

Global mean field amplitude (GMFA) will be calculated from TMS-evoked EEG recordings to quantify the overall cortical response to stimulation. Changes in GMFA amplitude will be assessed.
Baseline, immediately after the intervention
TMS-EEG Time-Frequency Power
Periodo de tiempo: Baseline, immediately after the intervention

Time-frequency analysis of TMS-EEG recordings will be used to assess changes in oscillatory power across frequency bands following stimulation.
Baseline, immediately after the intervention
TMS-EEG Functional Connectivity
Periodo de tiempo: Baseline, immediately after the intervention

Functional connectivity will be assessed using TMS-EEG recordings to evaluate changes in the synchronization and interaction of cortical brain regions.
Baseline, immediately after the intervention
TMS-EEG Source-Localized Cortical Activity
Periodo de tiempo: Baseline, immediately after the intervention

EEG source reconstruction will be used to estimate changes in TMS-evoked cortical activity at the source level.
Baseline, immediately after the intervention
TMS-Evoked Potential (TEP) Amplitude
Periodo de tiempo: Baseline, immediately after the intervention

TMS-evoked potentials (TEPs) will be analyzed to assess changes in cortical responses, including the amplitude of TMS-evoked EEG components.
Baseline, immediately after the intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Beijing HuiLongGuan Hospital

Investigadores

  • Investigador principal: Xiangyang Zhang, Ph.D, Tsinghua 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)

10 de noviembre de 2026

Finalización primaria (Estimado)

31 de octubre de 2027

Finalización del estudio (Estimado)

30 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

24 de octubre de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Publicado por primera vez (Actual)

9 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CASPsy13

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

The datasets generated and/or analyzed during the current study are not publicly available due to ethical restrictions (as they contain information that could compromise participant privacy), but will be available from the corresponding author upon reasonable request after completion of the study and approval by the ethics committee.

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

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. .

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