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Treatment of Complications to Diabetic Autonomic Neuropathy With Vagus Nerve Stimulation

NCT04143269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-06-07

No results posted yet for this study

Summary

The purpose of the DAN-VNS study is to investigate the effects of non-invasive vagal nerve stimulation on gastrointestinal symptoms such as nausea, vomiting, bloating, and diarrhea in people with diabetes.

Conditions

Interventions

DEVICE

Non-invasive transcutaneous vagus nerve stimulation

Bilateral stimulation 4 times per day for 7 days (period 1) and 2 times per day for 8 weeks (period 2). The two periods are separated by a 2 weeks wash-out period.

DEVICE

Sham vagus nerve stimulation

Bilateral stimulation 4 times per day for 7 days (period 1) and 2 times per day for 8 weeks (period 2). The two periods are separated by a 2 weeks wash-out period. The sham device produces a slight vibrating sensation, but do not provide any vagal nerve activation

Sponsors & Collaborators

  • ElectroCore INC

    collaborator INDUSTRY

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Asbjørn M Drewes, Professor · Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2023-02-01
Completion
2023-02-01
FDA Device
Yes

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04143269 on ClinicalTrials.gov