NCT06292962

Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain

Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain - A Randomized, Double-Blinded, Sham-Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Saima Abass Tahammal · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate the effects of non-invasive invasive vagal nerve stimulation on diabetic peripheral neuropathic pain in people with diabetes.

Detailed description

The study is a randomized, double-blinded, sham-controlled, parallel-group clinical trial, which will include participants with diabetic peripheral neuropathic pain. Participants are randomized to receive either active non-invasive transcutaneous vagal nerve stimulation (tVNS) or inactive sham stimulation. The study will investigate the effects of short-term, high-intensity tVNS treatment on peripheral pain. The primary outcome is subjective patient evaluation of pain symptoms by the use of validated questionnaires.

Conditions

• Diabetes Mellitus
• Diabetic Neuropathies
• Type2diabetes
• Neuropathic Pain

Interventions

Type	Name	Description
DEVICE	non-invasive transcutaneous vagal nerve stimulation (tVNS)	The device is used stimulate the vagus nerve
DEVICE	Sham device	Sham device that does not stimulate the vagus nerve

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-03-01
• Completion: 2024-03-03
• First posted: 2024-03-05
• Last updated: 2024-04-22

Locations

1 site across 1 country: Pakistan