Low Level Laser VS Transcutaneous Vagus Nerve Stimulation on Vascular Changes in Patients With Diabetic Polyneuropathy
NCT07078058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-20
Summary
To compare the effect of both low-level laser versus transcutaneous vagus nerve stimulation on vascular changes in patients with diabetic polyneuropathy
Conditions
- Transcutaneous Vagus Nerve Stimulation
- Diabetic Peripheral Neuropathy
Interventions
- DEVICE
-
Low level laser
Patients in the low level laser group will be irradiated with visible and near-infra-red lasers at a pulsed mode with a frequency of 35 Hz, peak power of 100 mW, and a spot diameter of 5 mm. The 15-minute sessions were performed three times a week for two months, with each laser having a power density of 0.35 mW/cm2 and an energy density of 32.08 J/cm2.
- DEVICE
-
Transcutaneous auricular Vagus nerve stimulation
Patients will receive 30 minutes of transcutaneous vagus nerve stimulation for 2 months, with 5 sessions per week. The antihelix and cymba concha will be sterilized with 75% alcohol, and the electrode will be attached. The device parameters include a wave width of 0.2 ms ± 30%, pulse frequency of 20 Hz, gradually increasing intensity to a tolerable intensity (4-6 mA), and duration of 30 minutes.
Sponsors & Collaborators
-
Horus University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-01
- Primary Completion
- 2025-10-01
- Completion
- 2026-03-01
Countries
- Egypt
Study Locations
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