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

3 novembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

70

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Dongmei Wang, Ph.D
  • Numero di telefono: +86 132 4190 1959
  • Email: wangdm@psych.ac.cn

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 60 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Comparatore fittizio: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hamilton Depression Rating Scale (HAMD-24)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hamilton Anxiety Rating Scale (HAMA)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beijing HuiLongGuan Hospital

Investigatori

  • Investigatore principale: Xiangyang Zhang, Ph.D, Tsinghua University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 novembre 2026

Completamento primario (Stimato)

31 ottobre 2027

Completamento dello studio (Stimato)

30 dicembre 2027

Date di iscrizione allo studio

Primo inviato

24 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 novembre 2026

Primo Inserito (Effettivo)

9 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CASPsy13

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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