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

Not Applicable

Completed

• Conditions: Diabetic Neuropathies; Diabetes Mellitus; Neuropathic Pain; Type2diabetes
• Interventions: Device: Sham device; Device: non-invasive transcutaneous vagal nerve stimulation (tVNS)

• Registration Number: NCT06292962
• Lead Sponsor: Saima Abass Tahammal

Brief 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.

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-12-24
• Study First Submitted QC: 2024-02-27
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-03
• Study First Posted: 2024-03-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Patients with Type 2 diabetes mellitus > 1 year
• Patients experiencing neuropathic pain

Exclusion Criteria

• Patients with co-morbidities such as chronic pain from other conditions
• Patients with serious complications of diabetes such as nephropathy and retinopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group STG	Sham device	Group STG will receive Inactive sham stimulation
Group VTG	non-invasive transcutaneous vagal nerve stimulation (tVNS)	Group VTG will receive active non-invasive transcutaneous vagal nerve stimulation (tVNS)

Primary Outcome Measures

Name	Time	Method
Neuropathic pain scores	up to 24 weeks	Change in neuropathic pain scores assessed by validated questionnaire

Secondary Outcome Measures

Name	Time	Method
Quality of life score	up to 24 weeks	Patient's perception of quality of life assessed by validated questionannaire

Trial Locations

Locations (1)

Shifa Hospital; 🇵🇰 Lahore, Pakistan