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NCT05977946 · ClinicalTrials.gov registry record · NA
Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects
A NA study of Hemostasis and Blood Biomarkers, sponsored by Spark Biomedical.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05977946: Completed NA study of Hemostasis and Blood Biomarkers, sponsored by Spark Biomedical.
NCT05977946 is a NA study of Hemostasis and Blood Biomarkers that has completed, run by Spark Biomedical. The registered enrollment target is 25 participants, below the 394-participant average among 7 other Hemostasis trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05977946, a NA study of Hemostasis and Blood Biomarkers, has completed, sponsored by Spark Biomedical.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed as a randomized, double-blind, sham-controlled, single-center research study in which healthy adults will be randomized 1:1 into one of two experimental groups, to receive transcutaneous auricular vagus nerve stimulation (taVNS) targeting either the auricular branch of the vagus nerve (ABVN) or tAN, which targets the ABVN and the auriculotemporal nerve (ATN): 1. Group 1: Sham taVNS followed by active taVNS 2. Group 2: Sham tAN followed by active tAN Participants will receive 30 minutes of sham stimulation (taVNS or tAN), followed by active stimulation (taVNS or tAN). Blood biomarkers (local and systemic) will be measured before and at several timepoints after stimulation to measure the molecular and cellular effects of the device.
Primary Outcome
Mean TAT levels in shed blood after active stimulation versus sham stimulation within each group
Conditions Studied
Interventions
- DEVICE Volta System
Study Locations (1)
New York
- The Feinstein Institutes for Medical Research - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-10-31 |
| Est. Completion | 2024-08-06 |
| Phase | NA |
What the finished NCT05977946 record still lists
NCT05977946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 394-participant average among 7 other Hemostasis trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Hemostasis appearing as the primary indexed condition, and to 1 intervention - of which Volta System is the first listed.
NCT05977946 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05977946 about?
NCT05977946 is a clinical study titled "Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects". This study is designed as a randomized, double-blind, sham-controlled, single-center research study in which healthy adults will be randomized 1:1 into one of two experimental groups, to receive transcutaneous auricular vagus nerve stimulation (taVNS) targeting either the auricular branch of the vag...
What is the current status of trial NCT05977946?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2023-10-31. Estimated completion is 2024-08-06.
What conditions does trial NCT05977946 study?
This clinical trial studies the following conditions: Hemostasis, Blood Biomarkers.
What interventions are being tested in trial NCT05977946?
The interventions under investigation include: Volta System (DEVICE).
Who is sponsoring clinical trial NCT05977946?
This trial is sponsored by Spark Biomedical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05977946 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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