Status:
COMPLETED
Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects
Lead Sponsor:
Spark Biomedical, Inc.
Collaborating Sponsors:
Northwell Health
Conditions:
Hemostasis
Blood Biomarkers
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 trans...
Eligibility Criteria
Inclusion
- Participant is between 18 and 65 years of age
- Participant is English proficient
- Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
Exclusion
- Participant has a history of thrombocytopenia (platelet count \<100k)
- Participant has reported coagulopathy (elevated prothrombin time (PT), elevated partial thromboplastin time (PTT), elevated activated clotting time (ACT))
- Participant has internal bleeding, external bleeding, easy bruising
- Participant has a history of abnormal bleeding or blood disorder, including anemia or anemia-related disorders
- Participant has a history of coagulopathy, including hemophilia, stroke, pulmonary embolism, myocardial infarction, or deep vein thromboses
- Participant has a history of conditions that can cause coagulopathic conditions, including atrial fibrillation, heart valve surgery or replacement, hip or knee replacement, or clotting disorders
- Participants using coagulation- or platelet-modifying therapies such as clotting factor products, emicizumab, desmopressin acetate, epsilon amino caproic acid, heparin and its derivatives, argatroban, desirudin, bivalirudin, warfarin, dabigatran, apixaban, edoxaban, betrixaban, or aspirin
- Participant has a history of chronic tobacco use or has ingested nicotine via smoking, vaping, smokeless tobacco, or nicotine patches in the past three months
- Participant has consumed caffeine within the past 12 hours
- Participant has received a blood transfusion within 30 days prior to study
- Participant has a history of epileptic seizures
- Participant has a history of neurologic diseases or traumatic brain injury
- Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators)
- Participant has abnormal ear anatomy or ear infection present
- Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
- Females who are pregnant, lactating or menstruating
- Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05977946
Start Date
October 31 2023
End Date
August 6 2024
Last Update
April 9 2025
Active Locations (1)
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1
The Feinstein Institutes for Medical Research
Manhasset, New York, United States, 11030