Combining HD-tDCS and iTBS in Treating Negative Symptoms of Schizophrenia
NCT07680959, Not applicable, Enrolling by invitation, Tri-Service General Hospital (TSGH)
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Combining HD-tDCS and iTBS in Treating Negative Symptoms of Schizophrenia | ClinicalTrials.gov |
| NCT number | NCT07680959 | ClinicalTrials.gov |
| Status | Enrolling by invitation | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Tri-Service General Hospital (TSGH) | ClinicalTrials.gov |
| Conditions | Negative Symptoms in Schizophrenia, Brain Stimulation Intervention | ClinicalTrials.gov |
| Interventions | active iTBS followed by active HD-tDCS, active iTBS followed by sham HD-tDCS, sham iTBS followed by active HD-tDCS, sham iTBS followed by sham HD-tDCS | ClinicalTrials.gov |
| First posted | 2026-07-02 | ClinicalTrials.gov |
| Last updated | 2026-07-09 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | The change in Positive and Negative Syndrome Scale (PANSS) negative subscale score | Fifteen weeks | PANSS is a clinician-administered rating scale to measure the severity of psychopathological symptoms of the patients with schizophrenia spectrum disorder. The patient is rated from 1 to 7 on 30 different symptom items. All items scores are summed up to yield a total PANSS score, which ranges from 30 to 210. A higher score indicates greater psychopathological symptom severity. PANSS negative subscale has 7 items with its score ranging from 7 to 49. The changes in the PANSS negative subscale score immediately after the 3-week intervention (primary endpoint), as well as at one-month and three-month follow-ups, will be collected as the primary outcome. | ClinicalTrials.gov |
| Secondary | The change in score of the Scale for the Assessment of Negative Symptoms (SANS) | Fifteen weeks | The Scale for the Assessment of Negative Symptoms (SANS) is used to assess negative symptoms in schizophrenia on a 25 item, 6-point scale. The SANS measures five domains of the negative symptoms including affective flattening or blunting, alogia, avolition - apathy, anhedonia - Asociality, Attention. In each domain, separate symptoms are rated from 0 (absent) to 5 (severe). A total SANS score ranges from 0 to 125. The changes in the SANS score immediately after the 3-week intervention, as well as at one-month and three-month follow-ups, will be collected as the secondary outcome. | ClinicalTrials.gov |
| Secondary | The change in score of Calgary Depression Rating Scale for Schizophrenia (CDSS) | Fifteen weeks | The participants' depressive symptoms will be measured by Calgary Depression Rating Scale for Schizophrenia (CDSS). The changes in the CDSS score immediately after the 3-week intervention, as well as at one-month and three-month follow-ups, will be collected as the secondary outcome. | ClinicalTrials.gov |
| Secondary | The change in the Personal and Social Performance scale (PSP) score | Fifteen weeks | PSP is a clinician-administered rating scale for measuring the psychosocial functioning of the patients with schizophrenia spectrum disorder. The PSP scale measures psychosocial functioning within four domains: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior.The patient is rated from 1 to 6 on each item of the four domains. A higher score indicates greater psychosocial functioning in any of the four domains. The final global score is defined according to a summary instruction table. This scale provides a single, overall rating from 1 to 100, where a higher score represents better personal and social function. The changes in the Personal and Social Performance scale (PSP) score immediately after the 3-week intervention, as well as at one-month and three-month follow-ups, will be collected as the secondary outcome. | ClinicalTrials.gov |
| Secondary | The change in the score of the Beck Cognitive Insight Scale (BCIS) | Fifteen weeks | Cognitive insight was measured by the Taiwanese version of the Beck Cognitive Insight Scale (BCIS), a self-reported instrument comprising 15 items.The Taiwanese BCIS is composed of 2 subscales including reflective attitude (9 items) and certain attitude (6 items). We obtained a R-C (reflective attitude minus certain attitude) index of the Taiwanese BCIS, representing the measurement of cognitive insight by subtracting the score of the certain attitude subscale from that of the reflective attitude subscale. Lower R-C index scores indicate poorer cognitive insight. The changes in the score of the Beck Cognitive Insight Scale (BCIS) immediately after the 3-week intervention, as well as at one-month and three-month follow-ups, will be collected as the secondary outcome. | ClinicalTrials.gov |
| Secondary | The change in the score of Schizophrenia Quality of Life Scale Revision Four (SQOLR4) | Fifteen weeks | The Chinese version of the Schizophrenia Quality of Life Scale Revision Four (SQOLR4) is a self-administered questionnaire of 33 items in two domains: psychosocial and vitality. All but four items are coded on a scale of 0-4 according to the frequency of occurrence during the previous 7 days (0 = always, 4 = never; the four exceptions are coded 0 = never, 4 = always). A higher score indicates higher health-related QoL. The changes in the score of Schizophrenia Quality of Life Scale Revision Four (SQOLR4) immediately after the 3-week intervention, as well as at one-month and three-month follow-ups, will be collected as the secondary outcome. | ClinicalTrials.gov |
| Secondary | The changes in the results of the Tower of London Drexel University Test 2nd Edition | Three weeks | The Tower of London Drexel University Test 2nd Edition is a neuropsychological test for the assessment of executive functioning specifically to detect deficits in planning, which may occur due to a variety of medical and neuropsychiatric conditions. The changes in the results of the Tower of London Drexel University Test 2nd Edition immediately after the 3-week intervention will be collected as the secondary outcome. | ClinicalTrials.gov |
| Secondary | The changes in the results of the Color Trails Test (CTT) | Three weeks | The CTT, a culture-neutral version of the Trail Making Test, was selected to measure sustained visual attention. The CTT consists of two parts (CTT-1 and CTT-2). The CTT-1 requires participants to connect a series of numbered circles that are randomly printed on a sheet of paper. In the CTT-2, numbered circles of 1 to 25 are shown twice (printed in pink and in yellow) randomly on a sheet of paper. Participants are asked to connect the numbers from 1 to 25 alternating between the two colors. The changes in the results of the Color Trails Test (CTT) immediately after the 3-week intervention will be collected as the secondary outcome. | ClinicalTrials.gov |
| Secondary | The changes in the results of the Stroop Color Word Test (SCWT) | Three weeks | Stroop Color Word Test (SCWT) will be administered to measure selective attention and cognitive flexibility. SCWT is composed of three parts, each lasting for 45 seconds. The changes in the results of the Stroop Color Word Test (SCWT) immediately after the 3-week intervention will be collected as the secondary outcome. | ClinicalTrials.gov |
| Secondary | The changes in indices of heart rate variability (HRV) derived from R-R intervals of ECG signals | Three weeks | HRV indices represent autonomic functioning. ECG electrodes will be placed on bilateral arms just below the elbows, with a ground electrode placed just above the right wrist bone. Lead I electrocardiogram of each patient will be taken for 5 min after sitting and having a rest for 20 min in a soundproof, dim-lighted room with thermostatic control. The ECG signals will be acquired, stored, pre-processed according to the recommended procedures and processed by an HRV analyser. The time domain of HRV is obtained: Standard deviation of NN intervals (SDNN). Power spectrum of HRV is quantified into the standard frequency-domain measurements including low-frequency power (LF, 0.04-0.15 Hz), high-frequency power (HF, 0.15- 0.40 Hz). The changes in indices of heart rate variability (HRV) derived from R-R intervals of ECG signals immediately after the 3-week intervention will be collected as the secondary outcome. | ClinicalTrials.gov |
| Secondary | The changes in resting-state EEG features | Three weeks | In a dimly lit, electrically shielded room, patients' electroencephalogram (EEG) will be recorded. Resting-state EEG will be collected with eye opened (5min) and closed (5min). Signals will be amplified by using EEG amplifiers and stored for offline analyses. The changes in resting-state EEG features (power, coherence, and microstates within different frequency bands including delta, theta, alpha and beta) immediately after the 3-week intervention will be collected as the secondary outcome. | ClinicalTrials.gov |
| Secondary | The changes in fNIRS features | Three weeks | Functional near infrared spectroscopy (fNIRS) system is used to measure the relative changes in oxyhemoglobin (Hb) of the frontal regions. Resting-state fNIRS fo 180s and verbal fluency task (VFT)-based fNIRS for 160s will be collected in a quiet room. The changes in fNIRS features immediately after the 3-week intervention will be collected as the secondary outcome. | ClinicalTrials.gov |
| Secondary | The changes in resting-state fMRI features | Three weeks | Magnetic Resonance Imaging (MRI) scans will be performed on the hybrid 3.0T PET-MR imaging unit (GE Healthcare, Waukesha, WI). MRI scans will be carried out using the same imaging protocol, including T1-weighted images and resting-state functional MRI (rs-fMRIs).The changes in resting-state fMRI features immediately after the 3-week intervention will be collected as the secondary outcome. | 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 6
The papers the trial lists on ClinicalTrials.gov.
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 5
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 |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Tower Planning | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | 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)