Safety and feasibility of paired vagus nerve stimulation with rehabilitation for improving upper extremity function in people with cervical spinal cord injury: study protocol for a pilot randomized controlled trial
Bibliographic record
Abstract
Introduction: Pairing vagus nerve stimulation with traditional rehabilitation therapies results in improved motor recovery in people with stroke. However, this approach has not yet been studied in people with spinal cord injury (SCI). Motor recovery continues to be challenging after SCI, and there is a need for innovative research strategies to enhance motor recovery after SCI. Hence, this pilot randomized controlled trial aims to evaluate the safety, feasibility, and potential efficacy of pairing vagus nerve stimulation (VNS) with rehabilitation therapy to restore the motor function of the paretic upper limbs in people with cervical SCI. Methods and analysis: In this triple-blind, randomized, sham-controlled pilot study, 8 adults with chronic incomplete SCI will be implanted with a VNS device and randomly assigned to either active VNS (0.8 mA) control VNS (0.0 mA) paired with upper limb rehabilitation. Each participant will undergo 18 in-clinic therapy sessions over 6 weeks, each lasting 120 min and delivered three times per week. Following the in-clinic phase, participants will continue with a 90-day home exercise program. Participants in both groups will receive similar goal-directed and intense upper limb rehabilitation. The therapy is focused on active movements, task specificity, high number repetitions, variable practice, and active participant engagement. Post-treatment assessment will occur immediately after in-clinic therapy and at 30 and 90 days of follow-up. After completion of blinding at 90 days follow-up, participants in the control group will be offered 6 weeks of in-clinic active VNS (0.8 mA) paired with rehabilitation. The safety of pairing VNS with rehabilitation will be assessed by the occurrence of adverse events in each group, and feasibility by the number of treatment sessions and follow-up visits attended and the number of dropouts. Potential efficacy will be assessed by measuring the change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) performance from baseline to immediately after in-clinic therapy and to 90 days. Secondary clinical outcome measures are the Toronto Rehabilitation Institute Hand Function Test, Capabilities of Upper Extremity Questionnaire, Spinal Cord Injury Independence Measure-III self-care subscore, and Spinal Cord Injury-Quality of Life scale. Ethics and dissemination: The trial protocol was approved by the Institutional Review Board of UTHealth (HSC-MS-22-0579). We anticipate publishing the results in a peer-reviewed journal within 1 year of study completion. Clinical trial registration: ClinicalTrials.gov, NCT05601661.
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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 | 0.021 | 0.019 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.010 | 0.005 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.006 | 0.005 |
| Insufficient payload (model declined to judge) | 0.038 | 0.007 |
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".