The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)
NCT05247125, Phase 4, Recruiting, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional) | ClinicalTrials.gov |
| NCT number | NCT05247125 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health | ClinicalTrials.gov |
| Conditions | Ischemic Stroke, Acute, Sleep Disorders, Circadian Rhythm | ClinicalTrials.gov |
| Interventions | Blue light exposure + Melatonin treatment, Melatonin treatment, Blue light exposure, Placebo | ClinicalTrials.gov |
| First posted | 2022-02-18 | ClinicalTrials.gov |
| Last updated | 2025-08-08 | ClinicalTrials.gov |
Registered outcomes 63
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in the value of National Institutes of Health Stroke Scale from baseline to 14 days after inclusion | From baseline to 14 days after treatment initiation | National Institutes of Health Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke, 0-42 scores, higher scores characterize worse impairment | ClinicalTrials.gov |
| Primary | Stroke-related disability assessed by the change in modified Rankin scale from baseline to 14 days after treatment initiation | From baseline to 14 days after treatment initiation | values of modified Rankin scale (scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke, from 0 (no symptoms) to 6 (dead) points) | ClinicalTrials.gov |
| Primary | Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14 days after treatment initiation | From baseline to 14 days after treatment initiation | Rivermead Mobility Index (a standardized scale used to assess mobility in patients with neurological deficits, a maximum of 15 points is possible; higher scores indicate better mobility performance) | ClinicalTrials.gov |
| Primary | Stroke-related disability assessed by the change in Barthel Index from baseline to 14 days after treatment initiation | From baseline to 14 days after treatment initiation | Barthel Index (a common scale used to measure performance in activities of daily living, 0-100 scores, higher scores define better performance) | ClinicalTrials.gov |
| Secondary | Change in Psychomotor vigilance task (mean reaction time) from baseline to 14 days after treatment initiation | From baseline to 14 days after treatment initiation | The psychomotor vigilance task is a sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus, the outcome (mean reaction time) is measured in msec | ClinicalTrials.gov |
| Secondary | Change in Psychomotor vigilance task (mean reaction time) from baseline to 90 days after inclusion | From baseline to 90±7 days after inclusion | The psychomotor vigilance task is a sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus, the outcome (mean reaction time) is measured in msec | ClinicalTrials.gov |
| Secondary | Change in Kraepelin test from baseline to 14 days after treatment initiation | From baseline to 14 days after treatment initiation | Kraepelin test is the test in which the examinee performs a simple single-digit addition. The outcome is the number of correct and incorrect addition operations per each 30 sec and during the whole task, performance index (number of correct addition operations during second part of task / number of correct addition operations during first part of task) | ClinicalTrials.gov |
| Secondary | Change in Kraepelin test from baseline to 90 days after inclusion | From baseline to 90±7 days after inclusion | Kraepelin test is the test in which the examinee performs a simple single-digit addition. The outcome is the number of correct and incorrect addition operations per each 30 sec and during the whole task, performance index (number of correct addition operations during second part of task / number of correct addition operations during first part of task) | ClinicalTrials.gov |
| Secondary | Change in Trail Making test from baseline to 14 days after treatment initiation | From baseline to 14 days after treatment initiation | Trails Making Test (Trails) is a neuropsychological test of visual attention and task switching. It can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning | ClinicalTrials.gov |
| Secondary | Change in Trail Making test from baseline to 90 days after inclusion | From baseline to 90±7 days after inclusion | Trails Making Test (Trails) is a neuropsychological test of visual attention and task switching. It can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. Execution time will be assessed (in msec) | ClinicalTrials.gov |
| Secondary | Change in Victoria Stroop test from baseline to 14 days after treatment initiation | From baseline to 14 days after treatment initiation | Victoria Stroop is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference. Execution time will be measured. (in msec) | ClinicalTrials.gov |
| Secondary | Change in Victoria Stroop test from baseline to 90 days after inclusion | From baseline to 90±7 day after inclusion | Victoria Stroop is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference. Execution time will be measured. (in msec) | ClinicalTrials.gov |
| Secondary | Change in Hopkins Verbal Learning Test (Revised) from baseline to 14 days after treatment initiation | From baseline to 14 days after treatment initiation | Hopkins Verbal Learning Test - Revised brief assessment of immediate recall, delayed recall and delayed recognition. The number of words recalled will be assessed. | ClinicalTrials.gov |
| Secondary | Change in Hopkins Verbal Learning Test (Revised) from baseline to 90 days after inclusion | From baseline to 90±7 days after inclusion | Hopkins Verbal Learning Test - Revised brief assessment of immediate recall, delayed recall and delayed recognition. The number of words recalled will be assessed. | ClinicalTrials.gov |
| Secondary | Change in Brief Visuospatial Memory Test (Revised) from baseline to 14 days after treatment initiation | From baseline to 14 days after treatment initiation | Brief Visuospatial Memory Test (Revised)is a commonly used, commercialized, assessment tool to measure visuospatial learning and memory abilities across research and clinical settings. The number of figures will be assessed. | ClinicalTrials.gov |
| Secondary | Change in Brief Visuospatial Memory Test (Revised) from baseline to 90 days after inclusion | From baseline to 90±7 days after inclusion | Brief Visuospatial Memory Test (Revised)is a commonly used, commercialized, assessment tool to measure visuospatial learning and memory abilities across research and clinical settings. The number of figures will be assessed. | ClinicalTrials.gov |
| Secondary | Change in Wechsler Memory Scale (Revised) from baseline to 14 days after treatment initiation | From baseline to 14 days after treatment initiation | Wechsler Memory Scale - Revised is a neuropsychological test designed to measure different memory functions in a person. A composite score will be assessed. | ClinicalTrials.gov |
| Secondary | Change in Wechsler Memory Scale (Revised) from baseline to 90 days after inclusion | From baseline to 90±7 days after inclusion | Wechsler Memory Scale - Revised is a neuropsychological test designed to measure different memory functions in a person. A composite score will be assessed. | ClinicalTrials.gov |
| Secondary | Change in Corsi block-tapping test from baseline to 14 days after treatment initiation | From baseline to 14 days after treatment initiation | The Corsi block-tapping test is a psychological test that assesses visuo-spatial short term working memory. The visual span raw score will be assessed. | ClinicalTrials.gov |
| Secondary | Change in Corsi block-tapping test from baseline to 90 days after inclusion | From baseline to 90±7 days after inclusion | The Corsi block-tapping test is a psychological test that assesses visuo-spatial short term working memory. The visual span raw score will be assessed. | 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 2
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 7
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 |
|---|---|---|
| Corsi Block-Tapping Test | Secondary outcome | ConductCognition |
| Psychomotor Vigilance Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | 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)