Trial · NCT07887997
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 15 | Baseline (Day 0) and Day 15 | The Positive and Negative Syndrome Scale (PANSS) is a clinician-rated instrument used to assess positive symptoms, negative symptoms, and general psychopathology in schizophrenia. The PANSS total score ranges from 30 to 210, with higher scores indicating greater schizophrenia symptom severity. The primary outcome is the change in PANSS total score from baseline to Day 15, compared between the active TI and sham groups. Change is calculated as the Day 15 total score minus the baseline total score, with negative values indicating improvement. |
| Secondary | Change From Baseline in PANSS Total Score at Days 7 and 45 | Baseline (Day 0), Day 7, and Day 45 | The PANSS total score ranges from 30 to 210, with higher scores indicating greater schizophrenia symptom severity. Change at each visit will be calculated as the visit total score minus the baseline total score. Negative changes indicate improvement. Day 7 and Day 45 will be evaluated separately. |
| Secondary | Change From Baseline in PANSS Positive Subscale Score | Baseline (Day 0), Day 7, Day 15, and Day 45 | The PANSS positive subscale comprises 7 items, each scored from 1 to 7, yielding a total score from 7 to 49. Higher scores indicate more severe positive symptoms. Change at each visit will be calculated as the visit score minus the baseline score; a negative value indicates improvement. |
| Secondary | Change From Baseline in PANSS Negative Subscale Score | Baseline (Day 0), Day 7, Day 15, and Day 45 | The PANSS negative subscale comprises 7 items, each scored from 1 to 7, yielding a total score from 7 to 49. Higher scores indicate more severe negative symptoms. Change at each visit will be calculated as the visit score minus the baseline score; a negative value indicates improvement. |
| Secondary | Change From Baseline in PANSS General Psychopathology Subscale Score | Baseline (Day 0), Day 7, Day 15, and Day 45 | The PANSS general psychopathology subscale comprises 16 items, each scored from 1 to 7, yielding a total score from 16 to 112. Higher scores indicate more severe general psychopathology. Change at each visit will be calculated as the visit score minus the baseline score; a negative value indicates improvement. |
| Secondary | Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Total Score | Baseline (Day 0), Day 7, Day 15, and Day 45 | The AHRS assesses the severity of auditory hallucinations across seven dimensions. As specified in the protocol, the total score ranges from 0 to 41, with higher scores indicating more severe auditory hallucinations. Change at each visit will be calculated as the visit total score minus the baseline total score; a negative value indicates improvement. |
| Secondary | Change From Baseline in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score | Baseline (Day 0), Day 7, Day 15, and Day 45 | The HAMD-17 is a 17-item clinician-rated measure of depressive symptom severity. Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. Changes from baseline to Days 7, 15, and 45 will be compared between the active TI and sham groups. Change is calculated as the total score at each follow-up visit minus the baseline total score, with negative values indicating improvement. |
| Secondary | Change From Baseline in 14-Item Hamilton Anxiety Rating Scale (HAMA-14) Total Score | Baseline (Day 0), Day 7, Day 15, and Day 45 | The HAMA-14 is a 14-item clinician-rated measure of anxiety symptom severity. Total scores range from 0 to 56, with higher scores indicating more severe anxiety symptoms. Changes from baseline to Days 7, 15, and 45 will be compared between the active TI and sham groups. Change is calculated as the total score at each follow-up visit minus the baseline total score, with negative values indicating improvement. |
| Secondary | Change From Baseline in Insomnia Severity Index (ISI) Total Score | Baseline (Day 0), Day 7, Day 15, and Day 45 | The ISI is a seven-item self-report measure of insomnia severity. Total scores range from 0 to 28, with higher scores indicating more severe insomnia. Changes from baseline to Days 7, 15, and 45 will be compared between the active TI and sham groups. Change is calculated as the total score at each follow-up visit minus the baseline total score, with negative values indicating improvement. |
| Secondary | Change From Baseline in Patient Health Questionnaire-15 (PHQ-15) Total Score | Baseline (Day 0), Day 7, Day 15, and Day 45 | The PHQ-15 is a 15-item self-report measure of somatic symptom burden. Total scores range from 0 to 30, with higher scores indicating greater somatic symptom burden. Changes from baseline to Days 7, 15, and 45 will be compared between the active TI and sham groups. Change is calculated as the total score at each follow-up visit minus the baseline total score, with negative values indicating improvement. |
| Secondary | Percentage of Participants With a Treatment Response Based on PANSS Total Score | Baseline (Day 0), Day 7, Day 15, and Day 45 | Treatment response is defined as a reduction of at least 30% in PANSS total score from baseline after correction for the scale minimum of 30 points. Percentage reduction is calculated as 100 × (baseline total score - follow-up total score) / (baseline total score - 30). Response rates at Days 7, 15, and 45 will be compared between the active TI and sham groups. Percentages will be based on all randomized participants in each group, with missing assessments classified as nonresponse in the main responder analysis. Observed-case and multiple-imputation analyses will assess the sensitivity of the results. |
| Secondary | Percentage of Participants Completing the Full Treatment Course | Day 1 through Day 14 | Treatment completion is defined as completion of all 28 scheduled stimulation sessions during the 14-day treatment period. Each completed session must include the full programmed 30-minute stimulation procedure, as documented in the device log. Completion rates will be compared between the active TI and sham groups using all randomized participants in each group as the denominator. Participants who complete fewer than 28 sessions, including those who do not initiate treatment, will be classified as not completing the treatment course. |
| Secondary | Percentage of Correct Treatment-Allocation Guesses by Participants and Outcome Assessors | Day 15, after completion of the 14-day treatment course | Blinding will be assessed on Day 15. Participants and independent clinical outcome assessors will separately indicate whether they believe the assigned treatment was active TI, sham TI, or do not know. Treatment allocation will not be disclosed as part of this assessment, and masking will be maintained through the Day 45 follow-up and until protocol-specified unblinding, except when emergency unblinding is necessary for participant safety. The percentage of correct guesses will be calculated separately for participants and assessors in each treatment group, using completed questionnaires as the denominator. Do not know responses will remain in the denominator and will not count as correct. Missing questionnaires will be reported separately. Confidence in the guesses and reasons for the responses will be summarized descriptively. |
| Secondary | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score | Baseline (Day 0), Day 7, Day 15, and Day 45 | The Clinical Global Impression-Severity (CGI-S) scale is a clinician-rated measure of overall illness severity, scored from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater illness severity. Changes from baseline to Days 7, 15, and 45 will be compared between the active TI and sham groups. Change is calculated as the score at each follow-up visit minus the baseline score, with negative values indicating improvement. |
| Secondary | Clinical Global Impression-Improvement (CGI-I) Score | Day 7, Day 15, and Day 45 | The Clinical Global Impression-Improvement (CGI-I) scale is a clinician-rated assessment of overall clinical change relative to baseline. Scores range from 1 (very much improved) to 7 (very much worse), with 4 indicating no change. Lower scores indicate greater improvement. CGI-I scores at Days 7, 15, and 45 will be compared between the active TI and sham groups. Because each rating already reflects change relative to baseline, no baseline CGI-I score or change-from-baseline score will be calculated. |
| Secondary | Percentage of Participants Experiencing Adverse Events | From the first stimulation session on Day 1 through the Day 45 follow-up visit | The percentage of participants experiencing at least one treatment-emergent adverse event will be summarized for the active TI and sham groups. Treatment-emergent adverse events are defined as new events or worsening of pre-existing conditions occurring from the first stimulation session through Day 45, regardless of their relationship to study procedures. Events will be characterized by severity, seriousness, relatedness, management, and outcome. Percentages will be calculated using participants who receive at least one stimulation session as the denominator, according to treatment received. |
| Secondary | Percentage of Participants Experiencing Serious Adverse Events | From the first stimulation session on Day 1 through the Day 45 follow-up visit | The percentage of participants experiencing at least one treatment-emergent serious adverse event from the first stimulation session through Day 45 will be summarized for the active TI and sham groups. Serious adverse events will be identified according to the protocol-defined criteria, including death, life-threatening events, hospitalization or prolonged hospitalization, and persistent or significant disability. Events will be recorded regardless of their relationship to study procedures. Percentages will be calculated using participants who receive at least one stimulation session as the denominator, according to treatment received. |
| Secondary | Changes From Baseline in Left Insular Gray Matter Volume and Related Functional Connectivity | Baseline (Day 0) and Day 15 | Structural and resting-state functional MRI data will be acquired at baseline and Day 15 to assess changes in left insular gray matter volume and related functional connectivity. Differences between the active TI and sham groups will be examined, along with associations between imaging changes and symptom improvement and the potential predictive value of baseline imaging and individualized electric-field measures. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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