Type 2 DiabetesNCT02130401
Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes
A study testing TNM Device in people with Type 2 Diabetes, run by Scion NeuroStim at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- TNM Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
UNC Highgate Specialty Center - UNC Diabetes Care Center
Chapel Hill, North Carolina, 27713
About this study
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
- Being tested
- TNM Device
- Keywords
- neuromodulation, caloric vestibular stimulation, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNM DeviceDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TNM Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 84 days of device use
Secondary outcomes (5)
Measurement of Lipid Panel
At the end of treatment (84 day) period, the patient's fasting lipid panel will be taken and compared with the baseline panel to assess any difference in lipid metabolism.
Measured: after 84 days of device use
Assessment of Quality of Life
At the end of the 84 day period of device use, the patient's reports on quality of life measures will be compared with baseline values to assess any improvement.
Measured: after 84 days of device use
Assessment of Mood
At the end of the 84 day period of device use, the patient's reports on mood measures will be compared with baseline values to assess any improvement.
Measured: after 84 days of device use
Assessment of Diabetes Related Self Care
At the end of the 84 day period of device use, the patient's reports on diabetes related self care will be compared with baseline values to assess any improvement.
Measured: after 84 days of device use
Feasibility of the Device as an Intervention for the Diabetes Population
At the end of the 84 day period of device use, the patient will be asked to assess the device use experience and note any shortcomings, challenges or difficulties.
Measured: after 84 days of device use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completionJun 2015
Why it stopped: Poor enrollment (15 planned, only 6 enrolled)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scion NeuroStim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lesco Rogers, MD, Study director, Scion NeuroStim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130401
- Sponsor's protocol ID
- SNS-DIA-01
- Status last verified
- May 2025
- First submitted
- 30 Apr 2014
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02130401
- Acronym / sponsor ID
- SNS-DIA-01
- Conditions
- Type 2 Diabetes
- Keywords
- neuromodulation, caloric vestibular stimulation, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment (15 planned, only 6 enrolled)
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Scion NeuroStimIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 May 2014 (estimated)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caloric Vestibular Stimulation (CVS) | Experimental | Device: TNM DeviceThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Has an A l c between 7.5 - 9.0% based upon point of care testing performed at visit 1.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNM 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. | Device | Caloric Vestibular Stimulation (CVS) |
Primary outcome
Measurement of Glycosylated Hemoglobin (A1c)
Time frame: after 84 days of device use
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.
5 secondary outcomes
Measurement of Lipid Panel
Time frame: after 84 days of device use
Assessment of Quality of Life
Time frame: after 84 days of device use
Assessment of Mood
Time frame: after 84 days of device use
Assessment of Diabetes Related Self Care
Time frame: after 84 days of device use
Feasibility of the Device as an Intervention for the Diabetes Population
Time frame: after 84 days of device use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesco Rogers, MD study director
Scion NeuroStim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TNM Device in people with Type 2 Diabetes, run by Scion NeuroStim at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Glycosylated Hemoglobin (A1c) (time frame: after 84 days of device use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.