University of Oklahoma — Biomedical Watch V2

Traitements4programmes

Essais2liés

Publications3liées

SourceDBlocale

Traitements

4

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
NAD Supplementation in Parkinson's DiseaseThe goal of this clinical trial is to learn whether Nicotinamide Riboside, a form of Vitamin B3 also known as NR, can improve blood vessel health in the brain, memory, and physical function in eligible study participants. NR is considered investigational for this study because it is not yet established for this specific use. The main questions it aims to answer are: Can NR improve non-invasive measures of blood vessel health in the brain? Can NR improve memory testing results and physical function? Researchers will compare participants who receive NR with participants who receive a placebo, an inactive substance that looks like the study drug, to see if NR has beneficial effects. Participants will be randomly assigned to receive either NR or placebo. They will complete 3 study visits over 13 weeks at the Translational Geroscience Laboratory at the University of Oklahoma Health Campus. During the visits, participants will complete questionnaires, memory testing, non-invasive blood vessel measurements, physical function tests, and a blood draw.	Parkinson	Non applicable	À vérifier	United States	À vérifier
Parasym deviceAtrial fibrillation (AF) is the most common cardiac arrhythmia. In previous experimental studies, the investigators found that low-level vagus nerve (VN) stimulation (LLVNS), at voltages substantially below that which slowed the sinus rate, significantly suppressed AF inducibility and decreased AF duration. The investigators subsequently developed a non-invasive neuromodulatory therapy, in which LLVNS was delivered to the auricular branch of the VN located at the tragus, the anterior protuberance of the outer canine ear (low level tragus stimulation; LLTS). The anti-arrhythmic effects of LLTS were similar to those of LLVNS delivered to the cervical VN trunk. More recently, in a proof-of-concept study in humans, the investigators showed that in patients with drug-refractory AF undergoing AF ablation, LLTS for just one hour significantly shortened the AF duration and decreased inflammatory cytokines. The overall objective of this proposal is to translate in ambulatory patients with paroxysmal AF the results of previous studies showing acute suppression of AF and inflammation in anesthetized canines as well as humans, in order to examine the long-term therapeutic effects of this approach. The investigators hypothesize that intermittent (1 hour daily) LLTS for 6 months may result in long-term decrease of AF burden and suppression inflammatory cytokines in patients with paroxysmal AF. Patients will be randomized to either active or sham LLTS. LLTS will be delivered through a transcutaneous electrical nerve stimulation (TENS) device for 1 hour daily over a 6-month period. AF burden will be defined as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous ECG monitoring at baseline and at 6 months. In addition, blood samples will be collected from patients at baseline, and at 3 and 6 months, for cytokine measurement. These investigations will establish the first evidence of the long-term effects of LLTS on AF suppression in patients with paroxysmal AF and may provide the basis for a potential expansion of the therapeutic targets of this treatment modality beyond AF.	SEP	Non applicable	Immunomodulation	United States	À vérifier
NAD Supplementation in Parkinson's DiseaseThe goal of this clinical trial is to learn whether Nicotinamide Riboside, a form of Vitamin B3 also known as NR, can improve blood vessel health in the brain, memory, and physical function in eligible study participants. NR is considered investigational for this study because it is not yet established for this specific use. The main questions it aims to answer are: Can NR improve non-invasive measures of blood vessel health in the brain? Can NR improve memory testing results and physical function? Researchers will compare participants who receive NR with participants who receive a placebo, an inactive substance that looks like the study drug, to see if NR has beneficial effects. Participants will be randomly assigned to receive either NR or placebo. They will complete 3 study visits over 13 weeks at the Translational Geroscience Laboratory at the University of Oklahoma Health Campus. During the visits, participants will complete questionnaires, memory testing, non-invasive blood vessel measurements, physical function tests, and a blood draw.	Parkinson	Non applicable	À vérifier	United States	À vérifier
Parasym deviceAtrial fibrillation (AF) is the most common cardiac arrhythmia. In previous experimental studies, the investigators found that low-level vagus nerve (VN) stimulation (LLVNS), at voltages substantially below that which slowed the sinus rate, significantly suppressed AF inducibility and decreased AF duration. The investigators subsequently developed a non-invasive neuromodulatory therapy, in which LLVNS was delivered to the auricular branch of the VN located at the tragus, the anterior protuberance of the outer canine ear (low level tragus stimulation; LLTS). The anti-arrhythmic effects of LLTS were similar to those of LLVNS delivered to the cervical VN trunk. More recently, in a proof-of-concept study in humans, the investigators showed that in patients with drug-refractory AF undergoing AF ablation, LLTS for just one hour significantly shortened the AF duration and decreased inflammatory cytokines. The overall objective of this proposal is to translate in ambulatory patients with paroxysmal AF the results of previous studies showing acute suppression of AF and inflammation in anesthetized canines as well as humans, in order to examine the long-term therapeutic effects of this approach. The investigators hypothesize that intermittent (1 hour daily) LLTS for 6 months may result in long-term decrease of AF burden and suppression inflammatory cytokines in patients with paroxysmal AF. Patients will be randomized to either active or sham LLTS. LLTS will be delivered through a transcutaneous electrical nerve stimulation (TENS) device for 1 hour daily over a 6-month period. AF burden will be defined as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous ECG monitoring at baseline and at 6 months. In addition, blood samples will be collected from patients at baseline, and at 3 and 6 months, for cytokine measurement. These investigations will establish the first evidence of the long-term effects of LLTS on AF suppression in patients with paroxysmal AF and may provide the basis for a potential expansion of the therapeutic targets of this treatment modality beyond AF.	SEP	Non applicable	Immunomodulation	United States	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
Parasym device	SEP	Non applicable	NCT02548754	TREAT-AF — Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation	COMPLETED
NAD Supplementation in Parkinson's Disease	Parkinson	Non applicable	NCT07703137	NAD Supplementation in Parkinson's Disease	ENROLLING_BY_INVITATION

Publications

3

Molécule	Indication / population	Titre	Journal	Date
NAD Supplementation in Parkinson's Disease		Evaluation of safety and effectiveness of NAD in different clinical conditions: a systematic review.	American journal of physiology. Endocrinology and metabolism
NAD Supplementation in Parkinson's Disease		The NAD-brain pharmacokinetic study of NAD augmentation in blood and brain using oral precursor supplementation.	iScience
NAD Supplementation in Parkinson's Disease		Nicotinamide Riboside Enhances Mitochondrial Bioenergetics and Dopaminergic Signaling Independent of Neuron Survival in a Double-Hit Parkinson's Model.	Research square