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 — DEVICE
    The 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)

FacilityCityStateZIPSite coordinators
UNC Highgate Specialty Center - UNC Diabetes Care CenterChapel HillNorth Carolina27713-

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