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

Scion NeuroStim

Status: Terminated

Conditions: Type 2 Diabetes

Treatments: Device: TNM Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02130401

SNS-DIA-01

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Caloric Vestibular Stimulation (CVS)

Experimental group

Description:

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.

Treatment:

Device: TNM Device