Status:
SUSPENDED
Acute Study of Effect of Ultrasound Vagus Nerve Stimulation on Glycemia
Lead Sponsor:
Aucta Technologies, Inc.
Collaborating Sponsors:
STATKING Clinical Services
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
21-60 years
Phase:
NA
Brief Summary
This is an early feasibility study to evaluate the proof of concept of modulation of glycemia by non-invasive ultrasound vagus nerve stimulation. This protocol is exploratory in nature, therefore it i...
Detailed Description
The DECIMA device comprises an array of two focused ultra-sound applicators arranged with overlapping foci to deliver acoustic energy to a known focal depth within tissue. The focused ultrasound appli...
Eligibility Criteria
Inclusion
- Written informed consent prior to any of the screening procedures
- Willingness to comply with all study procedures and available for the duration of the study
- Male or female age between 21 and 60 years old, inclusive
- Diabetes Mellitus Type 2 for at least 1 year
Exclusion
- HbA1c greater than 10.5%
- Medical treatment regimen with insulin
- Medical treatment with antiinflammatory drugs such as Disease-Modifying Antirheumatic Drugs (DMARDs), i.e. Methotrexate and Cytokine-inhibitors, e.g. Adalimumab, and Etanercept.
- Clinically significant neuropathy in the opinion of the investigator or as documented in the subject's medical history
- Abundant fat tissue in neck, as evidenced by a neck circumference of more than 20''
- Clinically significant surgical procedure(s) or skin lesion(s) in neck that would affect subject safety or placement of device
- Prior vagotomy
- History of clinically significant vasovagal syncope or presyncope
- Use of electrically active implanted medical device
- History of heat stroke or any heat intolerance that is deemed clinically significant in the opinion of the investigator
- History of renal dysfunction or a glomerulonephropathy defined as either nephritic or nephrotic syndrome, including estimated glomerular filtration rate of \<30 mL/min
- Clinically significant cardiovascular condition or problem that in the opinion of the investigator would interfere with the study data or affect patient safety (e.g. uncontrolled hypertension, congestive heart failure, or documented evidence of prior coronary artery disease).
- Pregnancy or plans to become pregnant while participating in the study, as determined by urine pregnancy test conducted at the screening visit for women of childbearing potential. A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable, or mechanical contraception; women who are single; women whose husbands have been vasectomized or whose husbands have received or are utilizing mechanical contraceptive devices.
- Uncontrolled asthma or obstructive lung disease.
- History of sepsis
- Significant cardiac rhythm disturbances in the opinion of the investigator based on an ECG.
- GI surgery that could have lacerated any branch of the vagus nerve, i.e. cholecystectomy, gastrectomy, pancreatic surgery, etc.
- Other conditions that could impair the patient's ability to participate in the study according to the investigator's opinion.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04094649
Start Date
August 1 2019
End Date
July 1 2022
Last Update
August 20 2021
Active Locations (1)
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1
Cognitive Clinical Trials, LLC
Scottsdale, Arizona, United States, 85258