Clinical evaluation of a novel disposable neurostimulator used to accelerate regeneration of injured peripheral nerves in the hand
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Bibliographic record
Abstract
BACKGROUND: Preclinical and early clinical evidence demonstrates that electrical stimulation (ES) applied for one hour following surgical nerve intervention enhances axonal regeneration and functional outcomes. Wide clinical implementation however, has been hindered by a lack of suitably designed stimulators. The aim of this pilot study was to investigate sensory recovery, safety, tolerability, and RCT feasibility for the use of a novel single-use stimulator to deliver ES therapy in an acute nerve transection cohort. METHODS: was used with intraoperative electrode implantation and 1-hour ES therapy delivered postoperatively. Patient tolerance was assessed during stimulation and visual-analogue pain scores were collected at the first post-operative visit. At 3- and 6-months post-op, sensory recovery and quality of life were assessed using 2-point discrimination, monofilament tests, and the Disability of Arm, Shoulder, and Hand (DASH) questionnaire, respectively. RESULTS: A total of 10 patients were enrolled. Intraoperative electrode placement did not impact operating room time, taking less than 5 minutes to implement. There were no related adverse events. Participants reported tolerable stimulation during ES therapy with no reports of pain. At the first post-operative visit patients had a mean visual-analogue pain score of 0.6 (range 0 - 1.9). Pressure threshold detection significantly improved between baseline, 3 months and 6 months. A greater proportion of ES treated patients (87.5%) had improved hand pressure thresholds (diminished light touch or diminished protective sensation) at 6 months compared to a historical comparator group. DASH scores improved over the timeline. Participants treated with ES therapy experienced minimal postoperative functional disability. CONCLUSIONS: prototype for the delivery of perioperative ES therapy was safe, well-tolerated, and usable. Sensory recovery was demonstrated and a larger RCT is feasible. TRIAL REGISTRATION: NCT04732936; 2021 - 01 - 29.
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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 | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 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 | 0.000 |
| 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 it