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

Saima Abass Tahammal

Status

Completed

Conditions

Type2diabetes

Neuropathic Pain

Diabetes Mellitus

Diabetic Neuropathies

Treatments

Device: non-invasive transcutaneous vagal nerve stimulation (tVNS)

Device: Sham device

Study type

Interventional

Funder types

Other

Identifiers

NCT06292962

SH-34988389

Details and patient eligibility

About

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.

Full 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.

Enrollment

165 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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