Online HD-tDCS Over the Left DLPFC During a Working Memory Task for Treating Negative Symptoms of Schizophrenia
NCT05582980, Not applicable, Completed, Tri-Service General Hospital (TSGH)
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Online HD-tDCS Over the Left DLPFC During a Working Memory Task for Treating Negative Symptoms of Schizophrenia | ClinicalTrials.gov |
| NCT number | NCT05582980 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Tri-Service General Hospital (TSGH) | ClinicalTrials.gov |
| Conditions | Schizophrenia, Schizoaffective Disorder, Mixed Type, Negative Symptoms in Schizophrenia | ClinicalTrials.gov |
| Interventions | HD-tDCS | ClinicalTrials.gov |
| First posted | 2022-10-17 | ClinicalTrials.gov |
| Last updated | 2025-05-13 | ClinicalTrials.gov |
Registered outcomes 22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | The change over time in the Chinese version of the Positive and Negative Syndrome Scale Factor Score for Negative Symptoms (PANSS-FSNS) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups). | Five 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. The five-factor PANSS model can be obtained by calculating from 26 of 30 items of PANSS to represent positive, negative, grandiosity/excitement, disorganization, and depression factor scores, respectively. In this model, PANSS-FSNS (7 items, N1+N2+N3+N4+N6+G7+G16, score 7-49) is selected as the primary outcome. | ClinicalTrials.gov |
| Secondary | The change over time in the score of the Chinese version of the Scale for the Assessment of Negative Symptoms (SANS) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups). | Five 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. | ClinicalTrials.gov |
| Secondary | The change over time in the scores of two subdomains of PANSS negative symptoms (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups). | Five weeks | PANSS is a clinician-administered rating scale to measure the severity of psychopathological symptoms of the patients with schizophrenia spectrum disorder, ranging from 30 to 210. A higher score indicates greater psychopathological symptom severity. Two subdomains of negative symptoms were identified from the PANSS: the Expressive Deficit domain (EXP domain, the sum of items of N1, N3, N6, G5, G7 and G13) including features of blunted affect and alogia and the Avolition-Apathy domain (AA domain, the sum of items of N2, N4, and G16) including manifestations of anhedonia, asociality and avolition. | ClinicalTrials.gov |
| Secondary | The change over time in the scores of the five-factor PANSS model other than FSNS (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups). | Five weeks | PANSS is a clinician-administered rating scale to measure the severity of psychopathological symptoms of the patients with schizophrenia spectrum disorder, ranging from 30 to 210. A higher score indicates greater psychopathological symptom severity. The scores of five-factor PANSS model other than FSNS can be obtained by calculating from 26 of 30 items of PANSS: positive (5 items, P1+P3+P5+P6+G9,score 5-35), grandiosity/excitement (4 items, score 4-28), disorganization (5 items, score 5-35), and depression (4 items, score 4-28) factor scores. | ClinicalTrials.gov |
| Secondary | The change over time in the score of the Chinese version of the Personal and Social Performance scale (PSP) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups). | Five weeks | A clinician-administered rating scale to measure 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. | ClinicalTrials.gov |
| Secondary | The change over time in the score of the self-reported version of the graphic personal and social performance scale (SRG-PSP) (from baseline to the timepoints immediately after intervention and at one-week follow-up) | Two weeks | The SRG-PSP is a self-rating scale of proven validity and reliability, comprising both male and female versions of cartoon-like pictures that are derived from the narrative text of the four domains of Personal and Social Performance (PSP) scale including the sub-items of socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviour. | ClinicalTrials.gov |
| Secondary | The change over time in the score of the abbreviated version of the Scale to Assess Unawareness in Mental Disorder in schizophrenia (SUMD) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups). | Five weeks | An expert-rating scale based on a patient interview to measure patients' clinical insight. The abbreviated version of SUMD comprises 9 items measuring current states of awareness as follows: (1) a mental disorder, (2) consequences of a mental disorder, (3) effects of drugs, (4) hallucinatory experiences, (5) delusional ideas, (6) disorganized thoughts, (7) blunted affect, (8) anhedonia, and (9) lack of sociability. Scores on each item range from 0 to 3. A score of 0 indicates 'not applicable'; 1, 'aware'; 2, 'somewhat aware/unaware' and 3, 'severely unaware.' Based on the 3 dimensions approach of the abbreviated version of SUMD, the scores on the items 1-3, 4-6 and 7-9 were averaged to obtain the dimension score of 'awareness of the disease', 'awareness of positive symptoms', and 'awareness of negative symptoms', respectively. All dimension scores were linearized on a 0-100 scale, with 0 and 100 indicating the lowest and highest level of unawareness, respectively. | ClinicalTrials.gov |
| Secondary | The change over time in the score of the Taiwanese version of the Beck Cognitive Insight Scale (BCIS) (from baseline to the timepoints immediately after intervention and at one-week follow-up) | Two 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. | ClinicalTrials.gov |
| Secondary | The change over time in the score of the Taiwanese version of the Self-Appraisal of Illness Questionnaire (SAIQ) (from baseline to the timepoints immediately after intervention and at one-week follow-up) | Two weeks | The Taiwanese version of the Self-Appraisal of Illness Questionnaire (SAIQ) was used to assess attitudes toward mental illness and experience of psychiatric treatment.This self-administered tool was composed of 17 items. The patients rated the extent to which they agreed with each statement of the item by using a four-point Likert scale, ranging from 1, ''do not agree at all'', to 4, ''completely agree''. Whether the scale score is in order from least to most or from the most to least depends on the content of the item statement. The total score of SAIQ ranges from 17 to 68. | ClinicalTrials.gov |
| Secondary | The change over time in the score of the Chinese version of the Schizophrenia Quality of Life Scale Revision Four (from baseline to the timepoints immediately after intervention and at one-week follow-up) | Two weeks | The Chinese version of the Schizophrenia Quality of Life Scale Revision Four 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. | ClinicalTrials.gov |
| Secondary | The change over time in the scores of Taiwanese version of Medication Adherence Rating Scale (from baseline to the timepoints immediately after intervention and at one-week follow-up). | Two weeks | The Taiwanese version of Medication Adherence Rating Scale (MARS), translated from the original MARS, was used to assess patients' beliefs about medication adherence. The translated MARS contains 10 yes/no items. Items 1-5 form the medication adherence subscale and items 6-10 form the subjective response to taking medication subscale. The scores from MARS subscales are summed to yield a total MARS score ranging from 0 (poor adherence to treatment) to 10 (good adherence to treatment), indicating a broad measure of medication compliance. | ClinicalTrials.gov |
| Secondary | The change over time in the total score of the Extrapyramidal Symptoms Rating Scale (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups). | Five weeks | Extrapyramidal Symptoms Rating Scale (ESRS) is a quantitative measure of antipsychotic-induced extrapyramidal movement symptoms. The ESRS is composed of the patient-assessed ESRS questionnaire and the physician-rated subscales for assessing parkinsonism/akathisia, dystonia movement, and dyskinesia movement. | ClinicalTrials.gov |
| Secondary | The changes over time in the results of Digit span (forward and backward) (from baseline to the timepoints immediately after intervention and at one-week follow-up) | Two weeks | A test to measure the capacity of working memory of the patients | ClinicalTrials.gov |
| Secondary | The changes over time in the results of Finger tapping test (from baseline to the timepoints immediately after intervention and at one-week follow-up) | Two weeks | A neuropsychological test that examines motor functioning, specifically, motor speed and lateralized coordination. | ClinicalTrials.gov |
| Secondary | The changes over time in the results of Continuous Performance (CPT, version 2.0) (from baseline to the timepoints immediately after intervention and at one-week follow-up) | Two weeks | A neuropsychological test that examines the performance of prefrontal-mediated task. | ClinicalTrials.gov |
| Secondary | The changes over time in the results of Wisconsin Card Sorting Test (WCST) (from baseline to the timepoints immediately after intervention and at one-week follow-up). | Two weeks | A neuropsychological test of "set-shifting", i.e. the ability to display flexibility in the face of changing schedules of reinforcement. | ClinicalTrials.gov |
| Secondary | The changes over time in the results of Tower of London test (from baseline to the timepoints immediately after intervention and at one-week follow-up) | Two weeks | 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. | ClinicalTrials.gov |
| Secondary | The changes over time in the results of Color Trails Test (CTT) (from baseline to the timepoints immediately after intervention and at one-week follow-up) | Two 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. | ClinicalTrials.gov |
| Secondary | The changes over time in the results of Stroop Color Word Test (SCWT) (from baseline to the timepoints immediately after intervention and at one-week follow-up) | Two weeks | Stroop Color Word Test (SCWT), Chinese version; was administered to measure selective attention and cognitive flexibility. SCWT is composed of three parts, each lasting for 45 seconds. | ClinicalTrials.gov |
| Secondary | The changes over time in indices of heart rate variability (HRV) measured at baseline, the end of stimulation, and 1-week follow-up. | Two weeks | HRV indices represent autonomic functioning. ECG electrodes were 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 was taken for 5 min after sitting and having a rest for 20 min in a soundproof, dim-lighted room with thermostatic control. At the four timepoints (baseline, after 10-session HD-tDCS, at 1-week and 1-month follow-ups), HRV will be collected during resting and during a dual 2-back task. The ECG signals were acquired, stored, pre-processed according to the recommended procedures and processed by an HRV analyser (LR8Z11, Yangyin Corp., Taipei, Taiwan). 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). | 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 |
|---|---|---|
| 38227007 | 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 9
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 |
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Finger Tapping Task | Secondary outcome | ConductCognition |
| 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)