Transcutaneous Vagus Nerve StimulationNCT07078058
Low Level Laser VS Transcutaneous Vagus Nerve Stimulation on Vascular Changes in Patients With Diabetic Polyneuropathy
A study testing Low level laser and Transcutaneous auricular Vagus nerve stimulation in people with Transcutaneous Vagus Nerve Stimulation and Diabetic Peripheral Neuropathy, run by Horus University at 1 site in Egypt.
Trial summary
To compare the effect of both low-level laser versus transcutaneous vagus nerve stimulation on vascular changes in patients with diabetic polyneuropathy Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Transcutaneous Vagus Nerve Stimulation, Diabetic Peripheral Neuropathy
- What is being tested?
- Low level laser and Transcutaneous auricular Vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient selection will be according to the following criteria:
- 30 patients diagnosed with diabetic neuropathy from both genders their ages will be ranged from 45-60 years old.
- All patients are ambulant independently.
- All patients are under full medical control
- Glycated hemoglobin is ranged from 6.5: 7 %.
- Patients have had diabetes for more than 5 or 10 years.
- patients experiencing painful peripheral neuropathic symptoms for more than 6 months involving both lower extremities and complained of burning pain with paresthesia in both legs.
- 7 Neurological examination revealed abnormal sensation appeared at the ends of the extremities.
Who cannot join
- Patients had unstable glycemic control and/or medical conditions that would confound assessment of neuropathy such as malignancy, active/untreated thyroid disease, peripheral vascular diseases, vascular insufficiency (claudication, skin discoloration, ulceration).
- Following the implantation of cardiac pacemakers or other electrical stimulation devices.
- Patient had sinus bradycardia, long QT syndrome, or other arrhythmias or mental disorders.
- Patients whose heart rate dropped below 50 beats/min after vagus nerve stimulation.
- Nerve damage as a result of prior reconstructive or replacement knee surgery, back surgery, spinal stenosis, spinal compression or radiculopathy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
out-patient clinic, faculty of physical therapy, Horus university
Damietta
About this study
Official title: Low Level Laser Versus Transcutaneous Vagus Nerve Stimulation on Vascular Changes in Patients With Diabetic Polyneuropathy
To compare the effect of both low-level laser versus transcutaneous vagus nerve stimulation on vascular changes in patients with diabetic polyneuropathy
Read the detailed description
Diabetic polyneuropathy is a prevalent and severe diabetes-related complication linked to cardiovascular mortality and disease events, even after accounting for risk factors and diabetes status.
Diabetic polyneuropathy affects the peripheral nervous system, leading to dysfunctions in sensory, motor, and autonomic nervous systems. It predisposes diabetics to refractory neuropathic pain, foot ulcers, and amputation, lowering quality of life, increasing mortality, and prompting patients with diabetes to seek medical attention.
Over half of diabetes patients experienced painful diabetic polyneuropathy over the past few decades Painful diabetic polyneuropathy therapy uses various drugs for symptom relief, but they often have systemic side effects and do not slow neuropathy progression. Therefore, investigating non-pharmacological interventions like low-level laser and transcutaneous auricular vagus nerve stimulation is crucial for developing more effective and potentially safer pain management options.
low-level laser therapy and transcutaneous auricular vagus nerve stimulation are emerging non-invasive interventions that have shown potential in alleviating pain associated with diabetic polyneuropathy, a common diabetes complication affecting quality of life.
The effectiveness of conservative treatment options for painful diabetic polyneuropathy needs further investigation. If one method proves superior in reducing pain, improving macrovascular health, and quality of life, it could guide clinical decisions
- Being tested
- Low level laser, Transcutaneous auricular Vagus nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laserDevice
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.
Transcutaneous auricular Vagus nerve stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Level Laser | Experimental | Patients will receive Low Level Laser irradiated with two wavelengths of visible 630 nm and near infra-red 810 nm for 15 min on entire surface of each foot three times a week for 2 months Receives: Device: Low level laser |
| Transcutaneous auricular Vagus nerve stimulation | Active comparator | Patients will receive 30 minutes Transcutaneous auricular Vagus nerve stimulation 3 sessions per week for 2 months. Receives: Device: Transcutaneous auricular Vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of change of vascular blood flow
The study uses Duplex Doppler ultrasound to assess vascular changes in the posterior tibial and anterior tibial, assessing anteroposterior diameter, Tunica intima thickness, and resistive index and peak systolic velocity using a variable frequency range.
Measured: at baseline and after 8 weeks
Secondary outcomes (2)
Assessment of change of Neuropathic Pain
The Douleur Neuropathique en 4 (DN4) is a screening questionnaire that consists of interview questions and physical tests to identify possible neuropathic pain. It has high test-retest and inter-rater reliability, with an ICC of 0.8 and a Cohen's kappa of 0.8. A total score is calculated as the sum of the 10 items. Scores _ 4 out 10 of indicate that neuropathic pain is likely.
Measured: at baseline and after 8 weeks
Assessment of change of Quality of life
The 12-Item Short Form Health Survey is a validated instrument used to assess health-related quality of life in clinical and research settings. It evaluates both physical and mental health through 12 questions derived from the short form-36 questionnaire, covering domains such as physical functioning, pain, general health, vitality, social functioning, and emotional well-being. The questionnaire generates two summary scores: the Physical Component Summary and the Mental Component Summary. Scoring is based on weighted responses to each item, with scores transformed to a standardized scale ranging from 0 to 100, where higher scores indicate better health status and quality of life. Due to its brevity, reliability, and ease of administration, the short form-12 is widely used for rapid assessment of overall patient health outcomes.
Measured: at baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Aug 2025
- Primary completion1 Oct 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Vagus Nerve StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Elbaz, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078058
- Sponsor's protocol ID
- Manar-005515
- Status last verified
- May 2026
- First submitted
- 12 Jul 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Laser Versus Transcutaneous Vagus Nerve Stimulation on Vascular Changes in Patients With Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT07078058
- Acronym / sponsor ID
- Manar-005515
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effect of both low-level laser versus transcutaneous vagus nerve stimulation on vascular changes in patients with diabetic polyneuropathy
Detailed description
Diabetic polyneuropathy is a prevalent and severe diabetes-related complication linked to cardiovascular mortality and disease events, even after accounting for risk factors and diabetes status.
Diabetic polyneuropathy affects the peripheral nervous system, leading to dysfunctions in sensory, motor, and autonomic nervous systems. It predisposes diabetics to refractory neuropathic pain, foot ulcers, and amputation, lowering quality of life, increasing mortality, and prompting patients with diabetes to seek medical attention.
Over half of diabetes patients experienced painful diabetic polyneuropathy over the past few decades Painful diabetic polyneuropathy therapy uses various drugs for symptom relief, but they often have systemic side effects and do not slow neuropathy progression. Therefore, investigating non-pharmacological interventions like low-level laser and transcutaneous auricular vagus nerve stimulation is crucial for developing more effective and potentially safer pain management options.
low-level laser therapy and transcutaneous auricular vagus nerve stimulation are emerging non-invasive interventions that have shown potential in alleviating pain associated with diabetic polyneuropathy, a common diabetes complication affecting quality of life.
The effectiveness of conservative treatment options for painful diabetic polyneuropathy needs further investigation. If one method proves superior in reducing pain, improving macrovascular health, and quality of life, it could guide clinical decisions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Level Laser | Experimental | Device: Low level laserPatients will receive Low Level Laser irradiated with two wavelengths of visible 630 nm and near infra-red 810 nm for 15 min on entire surface of each foot three times a week for 2 months |
| Transcutaneous auricular Vagus nerve stimulation | Active comparator | Device: Transcutaneous auricular Vagus nerve stimulationPatients will receive 30 minutes Transcutaneous auricular Vagus nerve stimulation 3 sessions per week for 2 months. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 30 patients diagnosed with diabetic neuropathy from both genders their ages will be ranged from 45-60 years old.
- All patients are ambulant independently.
- All patients are under full medical control
- Glycated hemoglobin is ranged from 6.5: 7 %.
- Patients have had diabetes for more than 5 or 10 years.
Key exclusion criteria (5 listed)
- Patients had unstable glycemic control and/or medical conditions that would confound assessment of neuropathy such as malignancy, active/untreated thyroid disease, peripheral vascular diseases, vascular insufficiency (claudication, skin discoloration, ulceration).
- Following the implantation of cardiac pacemakers or other electrical stimulation devices.
- Patient had sinus bradycardia, long QT syndrome, or other arrhythmias or mental disorders.
- Patients whose heart rate dropped below 50 beats/min after vagus nerve stimulation.
- Nerve damage as a result of prior reconstructive or replacement knee surgery, back surgery, spinal stenosis, spinal compression or radiculopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low level laserPatients 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 | Low Level Laser |
| Transcutaneous auricular Vagus nerve stimulationPatients 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. | Device | Transcutaneous auricular Vagus nerve stimulation |
Primary outcome
assessment of change of vascular blood flow
Time frame: at baseline and after 8 weeks
The study uses Duplex Doppler ultrasound to assess vascular changes in the posterior tibial and anterior tibial, assessing anteroposterior diameter, Tunica intima thickness, and resistive index and peak systolic velocity using a variable frequency range.
2 secondary outcomes
Assessment of change of Neuropathic Pain
Time frame: at baseline and after 8 weeks
Assessment of change of Quality of life
Time frame: at baseline and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser and Transcutaneous auricular Vagus nerve stimulation in people with Transcutaneous Vagus Nerve Stimulation and Diabetic Peripheral Neuropathy, run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of change of vascular blood flow (time frame: at baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.