Temporal Interference Stimulation Targeting Thalamus for Schizophrenia-Related Cognitive Dysfunction
NCT07927790, Not applicable, Not yet recruiting, Central South University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Temporal Interference Stimulation Targeting Thalamus for Schizophrenia-Related Cognitive Dysfunction | ClinicalTrials.gov |
| NCT number | NCT07927790 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Central South University | ClinicalTrials.gov |
| Conditions | Schizophrenia Disorder, Cognitive Impairments | ClinicalTrials.gov |
| Interventions | temporal interference stimulation, Sham TIS | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes in brain function | baseline (T1 structural scan); pre-, during, and post-first stimulation (Day 1); pre-, during, and post-second stimulation (Day 9) | Functional MRI (fMRI) is based on the blood oxygen level dependent (BOLD) contrast that can detect changes in blood oxygenation to analyze the change of brain function after intervention.This outcome is for sub-trial 1 (single-session crossover TIS). | ClinicalTrials.gov |
| Primary | changes on the MATRICS Consensus Cognitive Battery (MCCB) scores | baseline,2 week visit, 4-week follow-up visit | The MATRICS Consensus Cognitive Battery (MCCB) can be used for cognitive assessment of schizophrenia, bipolar disorder, and other neuropsychiatric diseases. The MCCB covers nine cognitive domains, including attention, information processing speed, verbal learning and memory, visual learning and memory, spatial working memory, reasoning, problem solving, social cognition, executive function, and fine motor skills. The working memory domain does not include verbal working memory because the Chinese language would not make feasible the inclusion of the LNS test.This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Changes in Positive and Negative Symptom Scale-6 (PANSS-6) scores | pre-and post-first stimulation (Day 1); pre- and post-second stimulation (Day 9) | The PANSS-6 is a shortened version of the Positive and Negative Syndrome Scale for assessment of psychotic symptoms in schizophrenia. Scores range from 6 to 42, higher score indicates more severe psychotic symptoms. This outcome is for sub-trial 1 (single-session crossover TIS). | ClinicalTrials.gov |
| Secondary | Change in brain responses during the Sternberg Item-Recognition Paradigm (SIRP) | pre-, during, and post-first stimulation (Day 1); pre-, during, and post-second stimulation (Day 9) | The Sternberg Item-Recognition Paradigm (SIRP) is a task fMRI paradigm for evaluating working memory processing. T1-weighted structural MRI at baseline is acquired for individual brain modeling. Task fMRI scans are obtained pre-stimulation, during stimulation, and post-stimulation for each session. This outcome is for sub-trial 1 (single-session crossover TIS). | ClinicalTrials.gov |
| Secondary | Changes in brain function | baseline, 2-week visit (end of intervention) | Functional MRI (fMRI) is based on the blood oxygen level dependent (BOLD) contrast that can detect changes in blood oxygenation to analyze the change of brain function after intervention.This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in PANSS total scores | baseline, 2-week visit (end of intervention), 4-week follow-up visit | The Positive and Negative Syndrome Scale (PANSS) is widely used to assess positive, negative and general psychopathology symptoms of schizophrenia. Scores range from 30 to 210, higher score indicates more severe positive and negative symptoms. This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in PSYRATS scores | baseline, 2-week visit (end of intervention), 4-week follow-up visit | The Psychotic Symptoms Rating Scale (PSYRATS) quantifies the severity and dimensional features of hallucinations and delusions in patients with psychosis. This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in SANS scores | baseline, 2-week visit (end of intervention), 4-week follow-up visit | The Scale for the Assessment of Negative Symptoms (SANS) evaluates the severity of negative symptoms in schizophrenia, including affective flattening, alogia, avolition-apathy, anhedonia-asociality and attentional impairment. This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in GAF scores | baseline, 2-week visit (end of intervention), 4-week follow-up visit | The Global Assessment of Functioning (GAF) scale rates overall psychological, social and occupational functioning. Scores range from 0 to 100, higher score represents better functional status. This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in Global Functioning Scale (GFS) scores | baseline, 4-week follow-up visit | The Global Functioning Scale (GFS) assesses real-world social and role functioning among individuals with severe mental disorders. This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in Social Functioning Scale (SFS) scores | baseline,4-week follow-up visit | The Social Functioning Scale (SFS) measures multiple domains of social functioning for patients with schizophrenia spectrum disorders. This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in brain responses during the 2-back task fMRI paradigm | 2-week visit (end of intervention) | Task fMRI based on the 2-back working memory paradigm used to assess working memory-related thalamocortical brain activity. High-resolution T1-weighted structural MRI at baseline is acquired for individual brain modeling. This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in 1/f aperiodic EEG signal (E/I balance index) | baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit | The 1/f aperiodic signal of resting-state electroencephalography is measured as an index of excitation-inhibition (E/I) balance. This outcome is for sub-trial 2 (2-week repeated TIS).This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in long-range temporal correlation (LRTC) of resting EEG | baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit | Long-range temporal correlation (LRTC) of resting-state electroencephalography is measured as an index of excitation-inhibition (E/I) balance.This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in functional E/I ratio (fE/I) of resting EEG | baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit | Functional E/I ratio (fE/I) from resting-state electroencephalography is measured as an index of excitation-inhibition (E/I) balance.This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in gamma oscillatory power of resting EEG | baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit | Gamma-band oscillatory power of resting-state electroencephalography is measured as an index of excitation-inhibition (E/I) balance.This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in beta oscillatory power of resting EEG | baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit | Beta-band oscillatory power of resting-state electroencephalography is measured as an index of excitation-inhibition (E/I) balance.This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in 40 Hz auditory steady-state response (40 Hz-ASSR) | baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit | 40 Hz auditory steady-state response (40 Hz-ASSR) is recorded by electroencephalography for excitation-inhibition balance assessment.This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in mismatch negativity (MMN) amplitude | baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit | Mismatch negativity (MMN) is recorded by electroencephalography for excitation-inhibition balance assessment.This outcome is for sub-trial 2 (2-week repeated TIS). | ClinicalTrials.gov |
| Secondary | Change in P50 sensory gating ratio | baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit | P50 sensory gating ratio is recorded by electroencephalography for sensory gating assessment.This outcome is for sub-trial 2 (2-week repeated TIS). | 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 2
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 |
|---|---|---|
| 2-Back Task | Secondary outcome | ConductCognition |
| Sternberg Memory Scanning | 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)