Electrophysiological Recordings of Deep Brain Stimulation in the Basal Ganglia (DBSMER)
26 octobre 2022 mis à jour par: Markey Olson, St. Joseph's Hospital and Medical Center, Phoenix
The pathology of Parkinson's disease (PD) and the mechanism of Deep Brain Stimulation surgery (DBS) are not completely understood.
The recording data that is used routinely as part of the procedure to map the target structures, however, may be analyzed in order to better understand the neural network dynamics in PD.
The purpose of the study is to perform simultaneous neural recordings from sub-cortical structures (e.g.
subthalamic nucleus [STN] or globus pallidus internus [GPi]) and the cerebral cortex.
These simultaneous recordings may provide insight in the pathology of PD and the mechanism of DBS.
The researchers will also study the effects of anesthesia level on neuron synchronization .
Recordings with micro-ECoG grid electrodes in the cortex show improved spatial resolution and these will be used to gain better understanding of cortical network dynamics and the synchronization with subcortical structures.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Subjects will be identified exclusively from the researchers' clinical practice for evaluation of DBS surgical candidacy for Parkinson's disease.
Once it is determined that a patient is an appropriate candidate for DBS placement (multidisciplinary team consensus) and has met inclusion criteria,the researchers will discuss the study with the subject and explain the rationale for the study as well as the implications the subject's participation has to their treatment.
Informed consent will be obtained prior to study procedures being performed.
Subjects will be in the study from the time of enrollment before surgery until all post-operative visits and tests are completed, usually by 6 months after surgery.
Follow-up during this time will consist of the standard follow-up schedule that all patients who undergo DBS follow.
This includes a clinic visit at 10-14 days, 12 weeks, and 6 months after DBS surgery.
Subjects will also have a follow-up neurocognitive evaluation consisting of the same evaluative tests administered pre-operatively.
These post-operative visits are standard for all patients undergoing DBS for Parkinson's.
Type d'étude
Interventionnel
Inscription (Réel)
34
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Arizona
-
Phoenix, Arizona, États-Unis, 85013
- St. Joseph's Hospital and Medical Center
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 85 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Parkinson's disease per Queens Square criteria
- Appropriate DBS candidate for multi-disciplinary team consensus
- Age 18 - 85 years of age
- Motor skills allowing for capability to complete evaluations
- Medically cleared for undergoing anesthesia and DBS surgery
Exclusion Criteria:
- Dementia per DSM-V criteria
- Medical or other condition precluding MRI
- History of supraspinal CNS disease other than PD
- Alcohol use of more than 4 drinks per day
- Pregnancy
- History of suicide attempt
- Currently uncontrolled clinically significant depression (BDI>20)
- History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
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 |
|---|---|
|
Autre: Deep Brain Stimulation
After informed consent is obtained, the patients will undergo routine DBS pre-operative evaluation and diagnostic testing.
This includes a pre-operative 3T-MRI with and without gadolinium as well as pre-operative medical clearance by the patient's PCP or general practitioner and/or other medical specialist if necessary.
They will also receive a baseline clinical evaluation including both motor function (Unified Parkinson's Disease Rating Scale on and off anti-parkinsonian medication) quality of life assessment (Parkinson's disease Questionnaire-39) and a full neuropsychological evaluation, if not already completed as part of the routine DBS candidacy evaluation within 2 months of surgery.
Subjects will have medical clearance from their specialists and be be evaluated by an internal medicine physician prior to surgery and cleared to proceed.
|
Subjects will have awake or asleep DBS surgery with STN or GPi placement.
Microelectrode recordings will define the electrophysiological target prior to lead implantation.
Cortical recordings will be done using µECoG grids (2.0 x 0.8 cm) placed over the cortex through the same burr hole used for lead implantation.
Neural recordings will be made continuously throughout the procedure: before, during, and after DBS, and at all levels of anesthesia.
A pulse generator will be connected and implanted either during the operation or within 7-10 days post-operatively.
Subjects will be admitted overnight for observation with anticipated discharge the next morning.
The researchers will also be collecting other routine data points (length of surgery, stereotactic accuracy, length of hospital stay, and post-operative complications).
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Neural Recordings
Délai: pre-operative; intra-operative ; 10-14 post-operative; 12 week post-operative; 6 months post-operative
|
Simultaneous neural recordings from sub-cortical structures (e.g.
subthalamic nucleus [STN] or globus pallidus internus [GPi]) and the cerebral cortex will be collected.
Recordings include action potentials and local field potentials from sub-cortical structures while subdural microelectrocorticography grids will be used to record local field potential from the cerebral cortex.
Time, frequency, and phase relationships between action potentials and local field potentials will also be studied in the context of the level of anesthesia.
Analysis of these simultaneous recordings, including assessing any changes, may provide insight in the pathology of PD and the mechanism of DBS.
|
pre-operative; intra-operative ; 10-14 post-operative; 12 week post-operative; 6 months post-operative
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Francisco A Ponce, MD, Barrow Brain and Spine physician with SJHMC privileges
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 février 2016
Achèvement primaire (Réel)
1 mars 2022
Achèvement de l'étude (Réel)
1 mars 2022
Dates d'inscription aux études
Première soumission
2 mars 2017
Première soumission répondant aux critères de contrôle qualité
16 mars 2017
Première publication (Réel)
23 mars 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 octobre 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 octobre 2022
Dernière vérification
1 octobre 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PHX-16-0017-70-06
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .