Pilot Study: A Multicenter, Prospective Study Demonstrating Safety, Usability, and Feasibility of Perioperative 1-hour Electrical Stimulation Therapy for Enhancing Peripheral Nerve Regeneration
Bibliographic record
Abstract
Background: Electrical stimulation (ES) applied for 1 hour following surgical intervention enhances axonal regeneration and functional outcomes. Clinical implementation, however, has been hindered due to the lack of appropriately designed stimulators. Methods: This multicenter, prospective, open-label study aimed to demonstrate the safety and device feasibility of a novel, single-use stimulator for implementing perioperative ES therapy in a variety of upper extremity surgical procedures. Patients undergoing surgical intervention for upper extremity nerve injury, neuropathy, or lesions were included. An investigational version of a novel therapeutic peripheral nerve stimulator was used to deliver 1-hour ES therapy perioperatively. Safety was assessed by the cumulation of adverse events. Patient tolerance to ES therapy was obtained during the treatment, and pain was also assessed at the first postoperative visit. Device usability questionnaires were completed by the study surgeons. Results: A total of 25 patients were enrolled. There were no related adverse events or adverse device effects. Implementation of the device took less than 5 minutes in the operating room in most cases. Bipolar stimulation was preferred, with a mean ± SD stimulus level of 2.2 ± 0.7 mA, and therapy was well tolerated. The mean first postoperative pain score was 1.2 out of 10. Surgeons indicated that perioperative implementation of the therapeutic peripheral nerve stimulator was easy and did not cause major disruptions to the clinical workflow. Conclusions: Perioperative application of 1-hour ES therapy is a feasible, safe, and promising approach to enhancing peripheral nerve regeneration as an adjunct to surgical intervention.
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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 | 0.006 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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".