- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07561372
Adaptive Recruitment Curve Analysis Using Bayesian Modeling
Enhancing Speed and Accuracy of Motor Evoked Potential Recruitment Curve Analysis Using Hierarchical Bayesian Modeling
The purpose of this study is to better understand how electrical or magnetic stimulation affect the nervous system by optimizing the way researchers measure muscle responses. The relationship between stimulation intensity and muscle response is described by "neural recruitment curves," which are critical for monitoring the state of the nervous system during therapies like transcranial magnetic stimulation (TMS) and spinal cord stimulation (SCS).
This study tests a new, real-time computational approach based on our previously developed methods (Hierarchical Bayesian models) to estimate these recruitment curves more efficiently. The primary goal is to use this model to dynamically guide the experiment, automatically selecting the optimal stimulation intensities to test.
The investigators hypothesize that this optimized approach will accurately estimate the entire recruitment curve, or specific targets components of it like the motor threshold, using significantly fewer samples than standard methods. By reducing the number of measurements required, this approach aims to decrease experimental time and minimize participant burden, making future TMS and SCS therapies and experiments more feasible and efficient.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: James R McIntosh, PhD
- Numéro de téléphone: +19294352335
- E-mail: jrm2263@cumc.columbia.edu
Lieux d'étude
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New York
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New York, New York, États-Unis, 10032
- Recrutement
- Columbia University Irving Medical Center
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Contact:
- James R McIntosh, PhD
- Numéro de téléphone: 9294352335
- E-mail: jrm2263@cumc.columbia.edu
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Chercheur principal:
- James R McIntosh, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Healthy adult volunteers aged 18 years and older.
- Able to understand study procedures and provide written informed consent.
Exclusion Criteria:
- 1. History of adverse reaction to Transcranial Magnetic Stimulation (TMS) or non-invasive neurostimulation.
- 2. History of seizures, epilepsy, or family history of epilepsy.
- 3. History of stroke, brain injury, or illness causing brain injury.
- 4. History of head injury or neurosurgery.
- 5. History of neurological diseases, or central nervous system lesions.
- 6. Presence of metallic implants or foreign bodies in the head (outside of dental work/fillings).
- 7. Presence of implanted electronic or medical devices (e.g., cardiac pacemakers, medical pumps, implanted stimulators).
- 8. Current pregnancy or possibility of pregnancy.
- 9. Currently taking medications that alter cortical excitability or lower seizure threshold.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Test of developed methods
Participants undergo distinct experiments within a single session to compare different neurostimulation sampling algorithms.
Each experiment involves recruitment curve sampling with different methods (e.g., Uniform, Expected Information Gain) to evaluate the accuracy and efficiency of motor threshold.
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Standard uniform distribution sampling used as a baseline comparison.
Algorithm: Adaptive threshold hunting using the Parameter Estimation by Sequential Testing (PEST) algorithm.
The proposed algorithms will deliver stimulation by using this magnetic stimulation methodology.
The proposed algorithms will deliver stimulation by using this electrical stimulation methodology.
An active sampling algorithm for recruitment curve estimation.
An alternative active sampling algorithm for recruitment curve estimation.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of stimuli to reach a pre-defined threshold error
Délai: Through completion of the study visit, 2-4 hours.
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Number of stimuli required for the compared methods to reach a pre-defined error threshold relative to the ground truth, computed from recruitment curves fitted after sampling using aggregated data.
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Through completion of the study visit, 2-4 hours.
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Number of stimuli to reach a pre-defined predictive curve error
Délai: Through completion of the study visit, 2-4 hours.
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Number of stimuli required for the compared methods to reach a pre-defined error threshold relative to the ground truth, computed from recruitment curves fitted after sampling using aggregated data.
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Through completion of the study visit, 2-4 hours.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean absolute error in a given parameter (e.g. threshold, predictive curve, slope) for a given number of stimuli
Délai: Through completion of the study visit, 2-4 hours.
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The error of the methods under comparison, with the ground truth computed from recruitment curves fitted subsequent to sampling using aggregated data.
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Through completion of the study visit, 2-4 hours.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: James R McIntosh, PhD, Columbia University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- AAAV6853
- 1R03NS141040-01A1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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