Vagus nerve stimulation to reduce pain and improve nerve function in diabetic neuropathy
Effect of Vagus Nerve Stimulation on Pain Intensity, Nerve Conduction Studies and Functional Outcomes in Diabetic Peripheral Neuropathy Patients
This test tries non-invasive transcutaneous vagus nerve stimulation to reduce foot pain and improve nerve conduction and function in people aged 45–60 with diabetic peripheral neuropathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 60 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Damietta) |
| Trial ID | NCT07405021 on ClinicalTrials.gov |
What this trial studies
Thirty adults with diabetic peripheral neuropathy will be enrolled at the outpatient clinic of the Faculty of Physical Therapy, Horus University (Damietta) and receive either transcutaneous auricular vagus nerve stimulation, sham stimulation, or a conventional physical therapy program. Pain intensity, neuropathic symptom severity, nerve conduction studies, and functional outcome measures will be collected before and after the intervention period. The study compares real stimulation against sham and standard therapy to see whether tVNS provides greater reductions in pain and objective improvements in nerve function. Safety and tolerability, including cardiac contraindications, will also be monitored throughout the protocol.
Who should consider this trial
Good fit: Adults aged 45–60 with a history of diabetes longer than five years, symptomatic glove‑and‑stocking numbness or burning pain in the feet, HbA1c between 6.5% and 7%, and the ability to walk independently are the intended participants.
Not a fit: People with pacemakers or other implanted electrical devices, significant cardiac arrhythmias, other neuromuscular disorders, active foot ulcers or major foot deformities, uncontrolled diabetes, or those outside the 45–60 age range are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, this could provide a non-drug option to reduce neuropathic pain, improve nerve function, and help people with diabetic neuropathy better perform daily activities.
How similar studies have performed: Small pilot studies of vagus nerve stimulation for some chronic pain syndromes have shown promising but inconsistent results, and robust evidence specifically for diabetic neuropathy is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Thirty patients diagnosed with diabetic neuropathy of both genders. * Age range between 45 and 60 years. * Presence of numbness and/or pain in the feet with no other identifiable cause. * Pain characterized as stabbing, electric shock-like, or burning in nature. * Presence of glove-stocking sensory changes and abnormal sensations in the distal lower limbs. * Ability to ambulate independently without assistance. * Patients under full medical control. * Hemoglobin A1c levels ranging from 6.5% to 7%. * History of diabetes mellitus for more than 5 years. Exclusion Criteria * Implantation of cardiac pacemakers or other electrical stimulation devices. * Presence of sinus bradycardia, sick sinus syndrome, or other cardiac arrhythmias. * Lumbar radiculopathy. * Psychiatric or mental disorders or history of seizures. * Visual or auditory impairments or tremors affecting balance. * Presence of other neuromuscular disorders. * Foot deformities or active foot ulcers. * History of lower limb surgical operations.
Where this trial is running
Damietta
- outpatient clinic, faculty of physical therapy, Horus university — Damietta, Egypt (Recruiting)
Study contacts
- Study coordinator: Hoda Mamdouh nematallah, assisstant lecturer
- Email: hmamdouh@horus.edu.eg
- Phone: 01096551775
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.