Pulmonary Function and Sleep-Related Disorders During Cervical Administration of Intrathecal Baclofen in Adults With Spinal Cord Injury (Cervit-B): Protocol for a Multiphase Single-Arm Intervention Trial
Bibliographic record
Abstract
BACKGROUND: The effect and safety of intrathecal baclofen (ITB) on generalized spasticity of the lower extremity have been well described in numerous studies, whereas the safety and effect on spasticity of the upper extremity during cervical administration seems to be less certain. OBJECTIVE: We aim to establish the safety of cervical administration of ITB on pulmonary function and sleep-related disorders in adults with a cervical spinal cord injury with functional hindering spasticity. In addition, we aim to explore the effect of cervical ITB on the reduction of spasticity; participant satisfaction; and improvement at the level of function, activities, and participation. METHODS: in capillary blood sample) should be between 4.5 and 6.5 kPa. In the first phase of the study, an extracorporeal pump will be used to investigate whether cervical administration of ITB leads to a reduction of spasticity without an adverse effect on pulmonary function and sleep-related disorders. In case of a safe (no adverse effects) and positive (reduction of spasticity) result of the trial, a baclofen pump will be implanted in the second phase of the study. After implantation, the dosage of ITB will be slowly increased, and eventually, the use of oral spasmolytics will be phased out. The dosage will be increased during the monitoring of pulmonary function and sleep-related disorders. In the second phase of the study, a pulse oximetry will be performed, and pulmonary function; spasticity; satisfaction; and the level of function, activities, and participation will be assessed at 3, 6, and 12 months after definitive implantation of the baclofen pump. RESULTS: The first participant was recruited on May 23, 2023. Data collection and analyses are expected to be completed in 2027. CONCLUSIONS: Currently, little is known about the safety and effectiveness of cervical administration of ITB for the treatment of upper extremity spasticity. We aim to establish the safety and explore the efficacy of this procedure. This paper describes the protocol of this study. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/70362.
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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 | 0.017 | 0.013 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.010 | 0.004 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.007 | 0.006 |
| Insufficient payload (model declined to judge) | 0.037 | 0.008 |
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".