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

NCT02130401 | Terminated Results

• 1 other identifier: SNS-DIA-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

neuromodulation; caloric vestibular stimulation; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Measurement of Glycosylated Hemoglobin (A1c)

  At the end of the 84 day period of device use, the patient's A1c value will be compared with the baseline value to assess any reduction.

  after 84 days of device use

Secondary Outcomes (5)

• Measurement of Lipid Panel

  after 84 days of device use

• Assessment of Quality of Life

  after 84 days of device use

• Assessment of Mood

  after 84 days of device use

• Assessment of Diabetes Related Self Care

  after 84 days of device use

• Feasibility of the Device as an Intervention for the Diabetes Population

  after 84 days of device use

Study Arms (1)

Caloric Vestibular Stimulation (CVS)

EXPERIMENTAL

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.

Device: TNM Device

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.

Caloric Vestibular Stimulation (CVS)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scion NeuroStim: lead

Study Sites (1)

UNC Highgate Specialty Center - UNC Diabetes Care Center

Chapel Hill, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The study was terminated early due to poor enrollment before any of the participants could complete the end of treatment assessments and outcome results could be collected.

Results Point of Contact

• Title: Dr. Robert Black
• Organization: Scion NeuroStim

bacllc@earthlink.net

(919) 260-5528

Study Officials

• Lesco Rogers, MD

  Scion NeuroStim

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 5, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-05

Locations

US (1)