ITRUSST consensus on biophysical safety for transcranial ultrasound stimulation
Bibliographic record
Abstract
Transcranial ultrasound stimulation (TUS) is an emerging technology for non-invasive brain stimulation. The International Transcranial Ultrasonic Stimulation Safety and Standards consortium (ITRUSST) has established consensus on considerations for nonsignificant biophysical risk of TUS, drawing upon the literature and established regulations for biomedical devices. Here, we assume the application of TUS to individuals without contraindications, compromised thermoregulation, vascular vulnerabilities, or administered ultrasound contrast agents. In this context, we present a concise yet comprehensive set of levels for nonsignificant risks of TUS application. For mechanical effects, it is non-significant risk if the mechanical index (MI) or the mechanical index for transcranial application (MI tc ) does not exceed 1.9. For thermal effects, it is non-significant risk if any of the following three levels are met: the peak temperature rise does not exceed 2°C or the peak absolute temperature does not exceed 39°C, assuming a baseline temperature of 37°C, the thermal dose does not exceed 2 CEM43 in brain tissue, 16 CEM43 in bone tissue, and 21 CEM43 in skin tissue, or specific values of the thermal index (TI) for a given exposure time. This report reflects a consensus expert opinion and can inform, but not replace, regulatory guidelines or official international standards. Similarly, this consensus can inform, but not replace, ethical evaluation, which weighs the total burden, risks, and benefits of the proposed action. The stated levels are not safety limits per se, and further data is needed to establish the threshold for significant risk. We review literature relevant to our considerations and discuss limitations and future developments of our approach.
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 machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.066 | 0.074 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.004 | 0.002 |
| Science and technology studies | 0.003 | 0.005 |
| Scholarly communication | 0.008 | 0.004 |
| Open science | 0.010 | 0.006 |
| Research integrity | 0.022 | 0.017 |
| Insufficient payload (model declined to judge) | 0.009 | 0.011 |
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 source (direct Gemma or distilled Codex), 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".