NCT07721272Toborzás még nem indultKorai 1. fázis
Human Cognition During Surgery: Stimulation-based and Cholinergic Modulation
Studying Human Cognition During Deep Brain Stimulation Surgery Using High-Density Neural Probes and Pharmacological Interventions
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 23.
Rövid összefoglaló (regiszter, angolul)
This is a research study to determine how COBENFY KarXT (FDA approved), a drug which has been approved for treatment of certain disorders, affects brain activity and cognitive tasks which may be regulated by the cholinergic system. This study aims to answer: 1) how cholinergic circuitries act during task performance in humans, and 2) develop a better understanding of how cognitive control interacts with learning, memory and decision making in the setting of cholinergic manipulation. Participants will complete a single treatment arm, regardless of which surgical procedure they are to receive. An anesthesiologist or other clinical staff will administer either the drug or the saline at a critical point which addresses the research questions, prior to patient surgery. This will be either with the drug, or the placebo pill. Half of the participants will be randomized to receive the drug, and the other half of these the placebo. Participants will be unaware whether the actual drug has been received. Essential tremor patients who participate will complete a cognitive task during an awake surgery. Epilepsy patients who participate will have a resting state recording during the procedure from the deep cortical layers of the brain. A probe will be used during the surgery to measure the effects of this drug and other procedures of the study on the cholinergic system. This probe is the clinical probe known as the AlphaOmega, which is FDA approved for standard of care procedures. Researchers will compare the brain activity between treatment arms to determine what brain activity changes based on the cholinergic manipulation.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- Korai 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 30 (tervezett)
- Első benyújtás
- 2026. júl. 17.
- Kezdés
- 2026. okt.
- Elsődleges befejezés
- 2030. szept.
- Fő szponzor
- University of Texas Southwestern Medical Center
- Betegségek
- Epilepszia
- NCT-szám
- NCT07721272
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · Korai 1. fázis
- Tervezett résztvevők: 30
- 2026. okt. és az elsődleges befejezés (2030. szept.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Contraindication to use of cholinergic modulation
- Contraindication for cholinergic modulation in both patient sets will be assessed by members of the treatment team (e.g. epileptologist), as well as a neuroanesthesiologist. Multiple medications and conditions are singular disqualifiers; however some medications are eliminated only in combination following neuroanesthesiologist evaluation. Patients at risk of reaction to the treatment arm based on concurrent or recent medications or other health conditions will be excluded from participation.
Más betegség
- Hepatic impairment (moderate or severe)?
- Renal impairment (moderate or severe)?
- History of hypersensitivity to COBENFY or trospium chloride?
- Biliary disease, including symptomatic gallstones, gallbladder disorders, pancreatitis?
Egyéb
- Patients with recent use (within one week) of anticoagulant or antiplatelet agent
- Contraindication to use of cholinergic modulation
- Patients with recent use (within one week) of anticoagulant or antiplatelet agent
- Female that is pregnant, breastfeeding, or has a positive pregnancy test?
- Under 18, over 70, or currently a prisoner on medical release?
- Untreated narrow angle glaucoma?
- Bladder obstruction, prostatic hyperplasia (BPH), diabetic cystopathy, pre-existing urinary retention?
- Fluoxetine, paroxetine, bupropion, terbinafine?
- Buspirone or eletriptan?
- Digoxin, colchicine, apixaban?
- Diphenhydramine, beztropine, oxybutynin?
- Benztropine, trihexyphenidyl, tolterodine, solifenacin, darifenacin, fesoterodine, hyoscyamine, dicyclomine, scopolamine?
Kiket keres a vizsgálat
- Diagnosis of Essential Tremor
- Recommended to undergo deep brain stimulation implantation surgery for surgical management of medication-resistant tremor based on clinical indications
- Diagnosis of intractable epilepsy
- Undergoing neuromodulation procedure that utilizes insertion of electrodes into subcortical structures, including the thalamus or hippocampus
- Undergoing neuromodulation procedure that utilizes frame-based insertion of electrodes into the thalamus (ANT or CM)
- Is patient between 18-70?
- In general good health, aside from history of epilepsy or essential tremor, as ascertained by medical history, physical exam, clinical labs, and ECG?
- Candidate for surgery as determined independently by the patient's treating physician/clinical team as part of the patient's routine medical care?
- Able to read, understand, and provide written, dated informed consent, and participate in cognitive tasks?
A regiszterben nem jelölt feltételek
- Study Population
Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Texas Southwestern Medical Center Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Dallas | Egyesült Államok | Ismeretlen állapot |
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