Ultra-early Gamma Knife stereotactic radiosurgery for trigeminal neuralgia (URGEnt-TN): study protocol for a single-center, two-arm, parallel group design, pragmatic, noninferiority, phase II, randomized controlled trial with intention-to-treat analysis for pre-refractory GK-SRS in classical or idiopathic TN
Bibliographic record
Abstract
BACKGROUND: Trigeminal neuralgia (TN) is a chronic, often debilitating neuropathic facial pain condition. First-line treatment is medical therapy, with carbamazepine (CBZ) being the gold standard. Surgery, including stereotactic radiosurgery in particular with Gamma Knife (GK-SRS), is usually considered when medical management fails, which occurs in >50% of patients. While surgery can provide long-term relief, prolonged disease duration before intervention is linked to a reduced response rate. A highly precise type of radiation therapy, GK-SRS is a non-invasive management option in TN, with a low risk of serious complications and fewer bothersome side effects compared to medical therapy. Evidence supports the safety and efficacy of GK-SRS in medically refractory TN, with published data suggesting that earlier intervention (within 3 years of pain onset) leads to improved long-term outcomes. However, the safety and efficacy of ultra-early GK-SRS-administered soon after TN diagnosis and before medical refractoriness-have not been examined. We hypothesize that ultra-early GK-SRS will yield superior long-term pain relief compared to ongoing medical management while also having a lower incidence of treatment-related adverse events (AEs). METHODS: We will perform a single-center, two-arm, randomized, controlled, parallel group design, pragmatic, noninferiority, phase II trial of ultra-early GK-SRS for TN in participants who will be treated before they have developed a medically refractory state and within 2 years of diagnosed TN per study neurologist. Eighty participants will be randomized 1:1 to either GK-SRS (intervention arm) or ongoing medical management (non-intervention/control arm). Crossover from the non-intervention/control arm to the intervention arm will be permitted. An intention-to-treat analysis will be conducted. The primary outcome will be the proportion of participants with satisfactory pain control at 2 years by the Barrow Neurological Institute Facial Pain Scale. DISCUSSION: This trial aims to test ultra-early GK-SRS as a first-line option in TN, based on a sound rationale for offering GK-SRS prior to failure of medical therapy. If validated, ultra-early GK-SRS will represent a paradigm shift in TN management leading to improved long-term pain control free from adverse medication-related side effects. TRIAL REGISTRATION: ClinicalTrials.gov NCT06949436. Registered on April 28, 2025.
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How this classification was reachedexpand
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 | 0.010 | 0.018 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.010 | 0.003 |
| Bibliometrics | 0.002 | 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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, 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".