Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- Scion NeuroStim
- Study ID
- NCT02130401
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- TNM Device — DEVICEThe device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes.
Study Details
This is an open-label, proof of concept study with a single active treatment arm designed to assess whether CVS-based stimulation has a beneficial effect on patients with type 2 diabetes. The primary outcome measure is a difference between pre and post-treatment A1c.
Key Dates
- Start date
- Jun 30, 2014
- Status verified
- May 2025
- Primary completion
- May 31, 2015
- Completion
- Jun 30, 2015
Study Design
- Enrollment
- 6 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Caloric Vestibular Stimulation (CVS)The TNM Device will provide a standardized active thermal waveform that will be used for all patients. The device is non-invasive and does not use electrical stimulation.
Primary Outcome Measure
Measurement of Glycosylated Hemoglobin (A1c) [ Time Frame: after 84 days of device use ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UNC Highgate Specialty Center - UNC Diabetes Care Center | Chapel Hill | North Carolina | 27713 | - |
Find similar trials in Chapel Hill, NC
By condition
By specialty
Related Studies
- Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes MellitusNot Yet Recruiting · Bionime Corporation · Guntersville, Alabama
- Addressing Barriers to Achieving Cardiometabolic Disorders Prevention and Treatment Goals for PLWH in the SE USRecruiting · Duke University · Charlotte, North Carolina
- Improving Appetite Self-Regulation in African American Adults With Type 2 DiabetesRecruiting · University of North Carolina, Chapel Hill · Kannapolis, North Carolina
- A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)PHASE3 · Recruiting · Eli Lilly and Company · Tucson, Arizona