Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes

NCT ID: NCT02130401

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-06-30

Brief Summary

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TNM Device

Intervention Type: 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.

Interventions

TNM 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

A subject is eligible for the study if all of the following criteria are met:

• Provide written informed consent prior to enrollment.
• Is male or female between 18-70 years old.
• Has been diagnosed with type II diabetes for greater than 12 months.
• Is currently either using lifestyle modification or taking one or two of the following oral antihyperglycemic agents and has been on stable doses for 90 days prior to screening:

• metformin
• DPP-4 inhibitors (sitagliptin, saxagliptin, alogliptin, linaglyptin)
• Pioglitazone
• Has an A l c between 7.5 - 9.0% based upon point of care testing performed at visit 1.
• Currently performs self-monitoring blood glucose checks at least 3 times per week.
• Able to adhere to protocol requirements.

Exclusion Criteria

A subject will be excluded if any of the following criteria are met:

• Has Type 1 Diabetes or Gestational Diabetes.
• Is pregnant or planning to become pregnant during the course of the study.
• Current use OR use in the past 6 months of sulfonylureas.
• Current use OR use in the past 6 months of insulin
• History of cardiovascular disease or cerebrovascular disease.
• Any planned surgery during the course of the study.
• Current continuous renal replacement therapy.
• Current oral or injectable steroid use or use within the previous 3 months.
• Previous or current treatment with deep brain stimulation.
• Any previous known disease, injury, or surgical intervention involving the brain or central nervous system.
• Moderate or greater hearing loss.
• Presence of a cochlear implant.
• Diagnosed vestibular dysfunction.
• Eye surgery within the previous three months.
• Any history of previous ear surgery.
• Active ear infections or a perforated tympanic membrane.
• Presence of a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scion NeuroStim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lesco Rogers, MD

Role: STUDY_DIRECTOR

Scion NeuroStim

Locations

UNC Highgate Specialty Center - UNC Diabetes Care Center

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

SNS-DIA-01

Identifier Type: -

Identifier Source: org_study_id