Safety of Bilateral Staged Magnetic Resonance‐Guided Focused Ultrasound Thalamotomy for Essential Tremor
Notice bibliographique
Résumé
Staged, open-surgical lesioning of the thalamic ventral intermediate nucleus to abate medication-refractory essential tremor (mrET) has been historically associated with a high frequency of adverse events (AEs), including speech and balance impairments.1 More recently, the real-time imaging and thermometry guidance offered by magnetic resonance-guided focused ultrasound (MRgFUS) have allowed for minimally-invasive thalamotomies with increased focal accuracy to address upper limb tremor in ET patients.2 Qualitative and semi-quantitative trials evaluating the safety of staged, bilateral MRgFUS thalamotomy have reported AEs that were mostly transient with mild to moderate severity based on patients' and physicians' perceived deficits.[3][4][5] However, a comprehensive quantitative analysis of the potential post-thalamotomy changes in stance and gait balance (ie, equilibrium), and oro-motor function is lacking.Further, cognitive assessments have been mostly limited to screening instruments.We comprehensively evaluated the incidence and severity of AEs, including changes in equilibrium, speech, and cognition, following staged, bilateral MRgFUS thalamotomy for patients with mrET.This prospective, open-label trial (NCT04720469) screened 16 consecutive mrET patients who had undergone MRgFUS thalamotomy at least 1 year prior (MRgFUS 1 ).Three patients were excluded due to mild cognitive impairment.Two others were excluded given abnormal gait, measured using the Scale for Assessment and Rating of Ataxia (SARA).6 The SARA's speech item revealed no baseline impairment.Eleven patients underwent MRgFUS 2 (seven males; median age 71 years, range 52-80 years; eight right-sided thalamotomy; Table S1).Tremor severity of individual hands was measured pre-and 3-6 months post-MRgFUS (median 3.9 months post-MRgFUS 1 ; median 4.4 post-MRgFUS 2 ) using Part A (resting, postural, action/intention) and Part B (Archimedes spiral/line drawing, water pouring) of the Clinical Rating Scales for Tremor (CRST).AEs were systematically captured during MRgFUS 2 and up to 6 months post-MRgFUS 2 .Pre-and post-MRgFUS 2 speech measures from eight patients were assessed using the Frenchay Dysarthria Assessment-2 (FDA-2), 7 a 99-word passage, and diadochokinetic single syllable repetition (eg, /pa/, /ta/, /ka).Vocal tremor was extracted as Frequency (FTrP) and Amplitude (ATrP) Tremor Power from maximum phonation task recordings (ie, "say 'ah' for as long as you can") using the TREMOR.PRAAT algorithm.8 The neuropsychological battery consisted of the Montreal Cognitive Assessment and tests measuring processing speed, attention/working memory, executive function, language, verbal fluency, and visuospatial perception.Least-square mean (LS-mean) with 95% confidence intervals (95%CI) were reported using generalized estimating equations in SAS9.4.CRST scores for the targeted hand improved after each MRgFUS (P < 0.001), while the untargeted-hand tremor had no significant change (Fig. 1A).Twenty-one AEs were identified with 81% rated as mild per the Common Terminology Criteria for AEs v5.0, consistent with other trials.[3][4][5] No severe AEs were
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».