dACC-Targeted Temporal Interference for Negative and Cognitive Symptoms in Schizophrenia
NCT07658898, Not applicable, Recruiting, Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | dACC-Targeted Temporal Interference for Negative and Cognitive Symptoms in Schizophrenia | ClinicalTrials.gov |
| NCT number | NCT07658898 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 74 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University | ClinicalTrials.gov |
| Conditions | Schizophrenia Disorder | ClinicalTrials.gov |
| Interventions | Temporal Interference Stimulation, Sham Temporal Interference Stimulation | ClinicalTrials.gov |
| First posted | 2026-06-22 | ClinicalTrials.gov |
| Last updated | 2026-08-21 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in the Positive and Negative Syndrome Scale Negative Symptom Subscale Score | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | The Positive and Negative Syndrome Scale Negative Symptom Subscale (PANSS-NS) consists of 7 items. Each item is rated from 1 to 7, yielding a total score ranging from 7 to 49. Higher scores indicate greater severity of negative symptoms. The change from baseline to immediately after the intervention will be compared between the active and sham stimulation groups. | ClinicalTrials.gov |
| Secondary | Change in the Brief Assessment of Cognition in Schizophrenia Composite Score | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | The Brief Assessment of Cognition in Schizophrenia (BACS) is a multidomain battery assessing overall neurocognitive functioning, including verbal learning and memory, working memory, psychomotor speed, verbal fluency, sustained attention and processing speed, and executive function. The constituent subtests include the List Learning Test, Digit Sequencing Task, Token Motor Task, Category Instances and Controlled Oral Word Association Test, Symbol Coding Task, and Tower of London Test. Domain scores are aggregated into a single composite z-score standardized against age- and sex-matched normative data. Lower values reflect greater cognitive impairment. | ClinicalTrials.gov |
| Secondary | Change in the Scale for the Assessment of Negative Symptoms Total Score | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | The Scale for the Assessment of Negative Symptoms (SANS) provides a detailed characterization of negative symptomatology. It comprises 25 clinician-rated items spanning five domains: affective flattening or blunting, alogia, avolition-apathy, anhedonia-asociality, and attentional impairment. Each item is rated on a six-point scale ranging from 0 to 5. The item scores are summed to generate a total score, where higher values denote a more severe negative symptom profile. | ClinicalTrials.gov |
| Secondary | Change in the Apathy Evaluation Scale Total Scor | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | The Apathy Evaluation Scale (AES-S) is a self-rated measure used to evaluate apathy. The scale consists of 18 items that probe the cognitive, affective, and behavioral dimensions of apathetic experiences over the preceding four weeks. Responses are summed to yield a total score ranging from 0 to 72. Higher scores indicate more severe apathy, meaning a worse outcome. | ClinicalTrials.gov |
| Secondary | Change in the Temporal Experience of Pleasure Scale Total Score | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | The Temporal Experience of Pleasure Scale (TEPS) is used to evaluate hedonic experience by separately indexing the anticipatory and consummatory components of pleasure. The scale consists of 20 items, with each item rated on a six-point Likert scale ranging from 1 ("very false for me") to 6 ("very true for me"). Following the reverse-scoring of designated items, responses are summed to yield a total score, where lower values indicate greater anhedonia. Therefore, higher scores indicate a better outcome. | ClinicalTrials.gov |
| Secondary | Change in the Personal and Social Performance Scale Score | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | The Personal and Social Performance Scale (PSP) is a clinician-administered tool used to evaluate real-world social functioning. It appraises four behavioral domains: engagement in socially constructive activities, interpersonal relationships, self-care, and disruptive or aggressive conduct. The total score spans from 1 to 100, with higher scores reflecting superior functional status. | ClinicalTrials.gov |
| Secondary | Change in the World Health Organization Quality of Life-BREF Score | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | Subjective quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF). This multidimensional instrument covers four domains: physical health, psychological well-being, social relationships, and environment. Higher scores within each domain reflect a more positive self-reported quality of life, meaning a better outcome. | ClinicalTrials.gov |
| Secondary | Incidence of Treatment-Emergent Adverse Events | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | The incidence and severity of adverse events will be assessed throughout the study period, from baseline to the 4-week follow-up, to evaluate treatment safety and tolerability. | ClinicalTrials.gov |
| Secondary | Change in Patient Health Questionnaire-9 (PHQ-9) Total Score | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | Current depressive symptomatology will be quantified using the Patient Health Questionnaire-9 (PHQ-9). It contains nine items, each rated on a scale from 0 to 3, yielding an aggregate score ranging from 0 to 27. Elevated scores reflect a more severe depressive burden. | ClinicalTrials.gov |
| Secondary | Baseline Credibility/Expectancy Questionnaire (CEQ) Score | Baseline before the first stimulation session | Participants' perceptions of the credibility of the intervention and their expectations regarding treatment benefit will be assessed using an adapted version of the Credibility/Expectancy Questionnaire (CEQ). Higher scores indicate greater perceived credibility and higher expectations for treatment benefit, which represents a more positive expectancy. | ClinicalTrials.gov |
| Secondary | Change in the Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | Broader psychopathological status will be assessed using the 30-item Positive and Negative Syndrome Scale (PANSS). Each of the 30 items is rated on a 1 to 7 ordinal scale, yielding a total score ranging from a minimum of 30 to a maximum of 210. Higher scores denote a more severe psychopathological profile, meaning a worse outcome. | ClinicalTrials.gov |
| Secondary | Change in Resting-State Functional Connectivity (rs-fMRI) | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | Exploratory analyses will investigate treatment-related neural changes using resting-state functional MRI (rs-fMRI). | ClinicalTrials.gov |
| Secondary | Change in Go/No-Go Task Accuracy | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | Response inhibition will be evaluated with the computerized Go/No-Go paradigm. The derived index reported here is overall accuracy, calculated as the percentage of correct responses. Higher accuracy percentages indicate better response inhibition and cognitive control, meaning a better outcome. | ClinicalTrials.gov |
| Secondary | Change in Generalized Anxiety Disorder-7 (GAD-7) Total Score | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | Anxiety over the preceding two weeks will be indexed by the Generalized Anxiety Disorder-7 scale (GAD-7). It comprises seven items, each scored from 0 to 3, which are summed to a maximum total score of 21. Higher totals denote greater anxiety severity. | ClinicalTrials.gov |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) Global Score | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | Sleep disturbance will be quantified with the Pittsburgh Sleep Quality Index (PSQI). It is a 19-item self-report measure that generates a composite global score ranging from 0 to 21. Higher values indicate worse sleep quality. | ClinicalTrials.gov |
| Secondary | Change in Stroop Color-Word Task Interference Effect | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | Conflict processing and cognitive control will be evaluated using the Stroop color-word task. The primary metric evaluated is the Stroop interference effect, calculated based on the differences in reaction times between congruent and incongruent trials. A lower interference effect score indicates better conflict processing and cognitive control, meaning a better outcome. | ClinicalTrials.gov |
| Secondary | Change in the Positive and Negative Syndrome Scale Positive Symptom Subscale Score | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | The positive symptom subscale of the 30-item Positive and Negative Syndrome Scale (PANSS) will be evaluated to assess broader psychopathological status. Clinician-assigned ratings for the items in this subscale are each anchored on a 1 to 7 ordinal scale. Higher scores denote a more severe positive symptom profile, meaning a worse outcome. | ClinicalTrials.gov |
| Secondary | Change in White Matter Structural Connectivity via Diffusion Tensor Imaging (DTI) | Baseline, immediately after the 2-week intervention, and at the 4-week follow-up | Exploratory analyses will investigate treatment-related neural changes using diffusion tensor imaging (DTI). Changes in white matter structural connectivity will be evaluated to assess neural target engagement. | 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 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 42745898 | DERIVED | PubMed |
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 4
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 |
|---|---|---|
| Go/No-Go Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Tower Planning | Secondary outcome | ConductCognition |
| Verbal Fluency | 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)