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NCT06292962 Clinical Trial

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

Diabetes Mellitus Clinical Trial

— VNSDPN  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06292962
Other study ID # SH-34988389
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date March 3, 2024

Study information
Verified date April 2024
Source Shifa International Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 165
Est. completion date March 3, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• non-invasive transcutaneous vagal nerve stimulation (tVNS)
The device is used stimulate the vagus nerve
• Sham device
Sham device that does not stimulate the vagus nerve

Locations
Country Name City State
Pakistan Shifa Hospital Lahore

Sponsors (2)
Lead Sponsor Collaborator
Saima Abass Tahammal Al Ain University

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Neuropathic pain scores Change in neuropathic pain scores assessed by validated questionnaire up to 24 weeks
Secondary Quality of life score Patient's perception of quality of life assessed by validated questionannaire up to 24 weeks
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