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New treatment option for Transcutaneous Vagal Nerve Stimulation (tVNS)
Official title Effect of Vagus Nerve Stimulation on Pain Intensity, Nerve Conduction Studies and Functional Outcomes in Diabetic Peripheral Neuropathy Patients
ClinicalTrials.gov ID: NCT07405021
What this study is testing
- What it's testing
- To evaluate the efficacy of vagus nerve stimulation in reducing neuropathic pain, symptom severity, electrophysiological studies and functional outcomes in patients with diabetic peripheral neuropathy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 60
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Damietta, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Damietta, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.