Abstract TP39: A Phase 2a randomized controlled trial of once-daily versus twice-daily remote ischemic conditioning in vascular cognitive impairment (TRIC-VCI)
Bibliographic record
Abstract
Background: Cerebral small vessel disease (CSVD) is a leading cause of vascular cognitive impairment (VCI). Remote ischemic conditioning (RIC) is a promising strategy to prevent CSVD progression, but it is unclear what doses of daily RIC are tolerable or adherable for older patients with CSVD-associated VCI. Methods: TRIC-VCI (ClinicalTrials.gov NCT04109963) was a prospective, open-label randomized-controlled trial with blinded endpoint assessment. Participants completing a 14-day run-in were randomized to once- or twice-daily RIC for 30 consecutive days. RIC consisted of 4 cycles of blood-pressure cuff inflation to 200mmHg around an arm for 5-minutes followed by 5-minutes deflation using an automated device. Criteria included age 60-85, evidence of CSVD on CT/MRI, Montreal Cognitive Assessment score 13-24, and preserved basic activities of daily living. Outcomes were assessed at 30- and 90-days. The primary outcome for which the trial was powered was adherence (completing ≥80% of sessions). Secondary outcomes included percentage of sessions completed and pain/discomfort scores from patient diaries. Exploratory outcomes included changes in white-matter hyperintensity (WMH) volume and cognitive tests. We explored trial experiences in a focus group with 5 patients and 4 care-partners. Results: Among 23 patients entering the run-in, 22 completed it and were randomized. 21/22(95.5%) finished the 30-day treatment period. 7/11(63.6%) in the once-daily RIC group completed ≥80% of sessions vs 10/11(90.9%) in the twice-daily group; median session completion was 93%(IQR:73-98%) vs 98%(IQR:93-98%) respectively. Pain/discomfort ratings were numerically higher in the twice-daily group (median rating/10: 4.2, IQR 1.0-5.0 vs once-daily:1.6, IQR 1.0-3.4, p=0.60). None of the patients developed tissue/neurovascular injury or deep vein thrombosis. Cognitive tests generally did not change significantly or differ between groups; WMH volumes were stable (change at 90-days vs randomization: -0.21 mL, 95%CI -0.54-0.13). Focus group participants opined the device was easy to use, desired greater portability, generally favoured once-daily RIC, and were open to longer treatment courses in future trials. Conclusion: RIC was safe and tolerated by patients with CSVD-associated VCI. Patients adhered well to both once- and twice-daily RIC, with no significant differences in outcomes between both groups. We will incorporate participant feedback into device design and future efficacy trials.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".