Individualized Temporal Interference Stimulation for Reward Processing in Late-Life Depression
NCT07925047, Not applicable, Not yet recruiting, Beijing HuiLongGuan Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Individualized Temporal Interference Stimulation for Reward Processing in Late-Life Depression | ClinicalTrials.gov |
| NCT number | NCT07925047 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 70 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beijing HuiLongGuan Hospital | ClinicalTrials.gov |
| Conditions | Major Depressive Disorder (MDD | ClinicalTrials.gov |
| Interventions | Active Temporal Interference Stimulation, Sham Temporal Interference Stimulation | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Hamilton Depression Rating Scale (HAMD-24) | 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. | ClinicalTrials.gov |
| Primary | Snaith-Hamilton Pleasure Scale (SHAPS) | 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. | ClinicalTrials.gov |
| Primary | Probabilistic Reversal Learning (PRL) Task | 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. | ClinicalTrials.gov |
| Secondary | Hamilton Anxiety Rating Scale (HAMA) | 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. | ClinicalTrials.gov |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | 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. | ClinicalTrials.gov |
| Secondary | Mini-Mental State Examination (MMSE) | 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. | ClinicalTrials.gov |
| Secondary | Auditory Verbal Learning Test (AVLT) Performance | 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. | ClinicalTrials.gov |
| Secondary | Verbal Fluency Test (VF) Performance | 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. | ClinicalTrials.gov |
| Secondary | 3D Confusion Assessment Method (3D-CAM) | 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. | ClinicalTrials.gov |
| Secondary | Clock Drawing Test (CDT) | 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. | ClinicalTrials.gov |
| Secondary | Digit Span Test (DST) Performance | 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. | ClinicalTrials.gov |
| Secondary | Trail Making Test (TMT) | 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. | ClinicalTrials.gov |
| Secondary | Neuropsychiatric Inventory (NPI) | 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. | ClinicalTrials.gov |
| Secondary | Activities of Daily Living (ADL) | 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. | ClinicalTrials.gov |
| Secondary | Resting-State fMRI Brain Network Measures | 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. | ClinicalTrials.gov |
| Secondary | TMS-Evoked Global Mean Field Amplitude (GMFA) | 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. | ClinicalTrials.gov |
| Secondary | TMS-EEG Time-Frequency Power | 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. | ClinicalTrials.gov |
| Secondary | TMS-EEG Functional Connectivity | 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. | ClinicalTrials.gov |
| Secondary | TMS-EEG Source-Localized Cortical Activity | Baseline, immediately after the intervention | EEG source reconstruction will be used to estimate changes in TMS-evoked cortical activity at the source level. | ClinicalTrials.gov |
| Secondary | TMS-Evoked Potential (TEP) Amplitude | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Probabilistic Reversal Learning | Primary outcome | ConductCognition |
| Category Fluency | Secondary outcome | ConductCognition |
| Clock Drawing Task | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)