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NCT05034419 · ClinicalTrials.gov registry record · Phase 1
Synaptic Plasticity in the Epicardial Ganglionated Plexi
A Phase 1 study of Atrial Fibrillation, sponsored by University of Oklahoma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT05034419: Recruiting Phase 1 study of Atrial Fibrillation, sponsored by University of Oklahoma.
NCT05034419 is a Phase 1 study of Atrial Fibrillation that is actively recruiting participants, run by University of Oklahoma. The registered enrollment target is 90 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05034419, a Phase 1 study of Atrial Fibrillation, is actively recruiting participants, sponsored by University of Oklahoma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
Atrial fibrillation (AF) is the most common arrhythmia and the prevalence increase with age. Autonomic nervous system play a critical role in the initiation and maintenance of AF. The intrinsic cardiac autonomic nervous system includes ganglionated plexus (GP) modulate the level of parasympathetic activity to the heart. Experimental and clinical studies suggest that GP activation plays a significant role in clinical AF in both the initiation of and the maintenance of AF. Synaptic plasticity is defined as the ability of synapses to change their strength of transmission. Plasticity of synaptic connections in the brain is a major focus of neuroscience research, as it is the primary mechanism underpinning learning and memory. Beyond the brain however, plasticity in peripheral neurons is less well understood, particularly in the GP neurons innervating the heart. The ability of these neurons to alter parasympathetic activity suggests that plasticity may indeed occur at the synapses formed on and by GP neurons. Such changes may not only fine-tune autonomic innervation of the heart, but could also be a source of maladaptive plasticity during atrial fibrillation. Low level tragus stimulation (LLTS) has been shown to decrease AF burden among patients with paroxysmal AF. However, the exact mechanism remains unclear. The objective of this study is to examine changes in synaptic density of GP neurons in patients with paroxysmal AF and persistent AF compared to those without AF undergoing cardiac surgery. In addition, we aim to examine the effect of LLTS on the synaptic plasticity of the GP neurons. A group of patients undergoing open heart surgery will be randomized to active LLTS for 30 min (pulse width of 200 μs, amplitude of 20 mA and a pulse frequency of 20 Hz) or no stimulation. Biopsy from GP tissue will be taken immediately after stimulation and histological staining for choline acetyl transferase (ChAT), tyrosine hydroxylase (TH) and synaptophysin will be performed to
Conditions Studied
Interventions
- DEVICE Sham stimulation
- DEVICE Parasym
Study Locations (1)
Oklahoma
- OU Medical Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2021-03-24 |
| Est. Completion | 2024-12 |
| Phase | Phase 1 |
What NCT05034419 shows while recruiting
NCT05034419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Sham stimulation is the first listed.
NCT05034419 reports a single indexed study location in Oklahoma.
Frequently Asked Questions
What is clinical trial NCT05034419 about?
NCT05034419 is a clinical study titled "Synaptic Plasticity in the Epicardial Ganglionated Plexi". Atrial fibrillation (AF) is the most common arrhythmia and the prevalence increase with age. Autonomic nervous system play a critical role in the initiation and maintenance of AF. The intrinsic cardiac autonomic nervous system includes ganglionated plexus (GP) modulate the level of parasympathetic a...
What is the current status of trial NCT05034419?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2021-03-24. Estimated completion is 2024-12.
What conditions does trial NCT05034419 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT05034419?
The interventions under investigation include: Sham stimulation (DEVICE), Parasym (DEVICE).
Who is sponsoring clinical trial NCT05034419?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05034419 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05034419's enrollment target sits among peer trials
90 146th of 202 higher than 56 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
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