An interventional study of Active Temporal Interference Stimulation and Sham Temporal Interference Stimulation in Major Depressive Disorder (MDD, sponsored by Beijing HuiLongGuan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Beijing HuiLongGuan Hospital · Not applicable, Interventional, and Treatment
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.
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 70 is below the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Beijing HuiLongGuan Hospital is the lead sponsor of 22 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: Active 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).
Device: Sham 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).
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).
Hamilton Depression Rating Scale (HAMD-24)
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.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Snaith-Hamilton Pleasure Scale (SHAPS)
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.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Probabilistic Reversal Learning (PRL) Task
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.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Hamilton Anxiety Rating Scale (HAMA)
Anxiety severity will be assessed using the 14-item HAMA. Total scores range from 0 to 56, with higher scores indicating more severe anxiety.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Mini-Mental State Examination (MMSE)
Global cognitive function will be assessed using the MMSE. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Auditory Verbal Learning Test (AVLT) Performance
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.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Verbal Fluency Test (VF) Performance
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.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
3D Confusion Assessment Method (3D-CAM)
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.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Clock Drawing Test (CDT)
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.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Digit Span Test (DST) Performance
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.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Trail Making Test (TMT)
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.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Neuropsychiatric Inventory (NPI)
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.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Activities of Daily Living (ADL)
Daily functioning will be assessed using the 20-item ADL scale. Scores range from 20 to 80, with higher scores indicating greater functional impairment.
Time frame: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Resting-State fMRI Brain Network Measures
Resting-state fMRI will be used to evaluate changes in nucleus accumbens-related functional connectivity and brain network characteristics following the intervention.
Time frame: Baseline, immediately after the intervention
TMS-Evoked Global Mean Field Amplitude (GMFA)
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.
Time frame: Baseline, immediately after the intervention
TMS-EEG Time-Frequency Power
Time-frequency analysis of TMS-EEG recordings will be used to assess changes in oscillatory power across frequency bands following stimulation.
Time frame: Baseline, immediately after the intervention
TMS-EEG Functional Connectivity
Functional connectivity will be assessed using TMS-EEG recordings to evaluate changes in the synchronization and interaction of cortical brain regions.
Time frame: Baseline, immediately after the intervention
TMS-EEG Source-Localized Cortical Activity
EEG source reconstruction will be used to estimate changes in TMS-evoked cortical activity at the source level.
Time frame: Baseline, immediately after the intervention
TMS-Evoked Potential (TEP) Amplitude
TMS-evoked potentials (TEPs) will be analyzed to assess changes in cortical responses, including the amplitude of TMS-evoked EEG components.
Time frame: Baseline, immediately after the intervention
Plan to share: No — 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2027, 11 months later.
Of 647 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's planned 11 months is below that.
Counting every sponsor, half of 687 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Beijing HuiLongGuan Hospital