Transcutaneous Vagal Nerve Stimulation (tVNS)NCT07405021
Effect of Vagus Nerve Stimulation on Pain Intensity, Nerve Conduction Studies and Functional Outcomes in Diabetic Peripheral Neuropathy Patients
A study testing Conventional physical therapy program and Transcutaneous auricular vagus nerve stimulation in people with Transcutaneous Vagal Nerve Stimulation (tVNS) and Diabetic Polyneuropathy, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Transcutaneous Vagal Nerve Stimulation (tVNS), Diabetic Polyneuropathy
- What is being tested?
- Conventional physical therapy program and Transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
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- Patients under full medical control.
- Hemoglobin A1c levels ranging from 6.5% to 7%.
- History of diabetes mellitus for more than 5 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
outpatient clinic, faculty of physical therapy, Horus university
Damietta
Hoda Mamdouh Nematallah, Assisstant lecturer, 01096551775, hmamdouh@horus.edu.eg
About this study
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.
Read the detailed description
Diabetes is a major global health problem affecting half a billion people worldwide. Its global prevalence is rising at an alarming rate and has been forecast to reach 700 million by 2045. Diabetic neuropathy is an important and common complication of diabetes, with a lifetime prevalence of more than 50% among people with diabetes. Diabetic neuropathy is an insidious and often disabling disease.
Sensory symptoms are diverse, ranging from numbness to dysesthesia, pain and allodynia, and typically begin in the feet and spread proximally. Motor function can also be affected, preventing patients from engaging in activities of daily living. More recently, the considerable psychosocial and quality of life impacts of Diabetic neuropathy have been recognized. Furthermore, Diabetic neuropathy is a major risk factor for diabetic foot ulceration, which is an independent risk factor for lower limb amputation and mortality. The associated economic burden is high; the annual cost of managing Diabetic neuropathy exceeds billions of dollars in different countries .
Current treatments are purely symptomatic and the most commonly recommended first-line agents include anticonvulsants (gabapentin and pregabalin), serotonin-noradrenaline reuptake inhibitors, and tricyclic antidepressants. Unfortunately, the therapeutic effect may offset by intolerable adverse effects.
In this study, evidence for a potentially effective, non-pharmacological treatment option for Diabetic neuropathy will be provided. Positive findings could lead to improved management strategies for Diabetic neuropathy, reducing the burden of chronic pain and enhancing the overall well-being of diabetic patients. Vagus nerve stimulation has emerged as a potential intervention, offering promise in modulating neuropathic pain and improving functional outcomes.
Furthermore, understanding the mechanisms through which transcutaneous Vagus nerve stimulation affects pain and nerve function may offer insights into broader applications of vagus nerve stimulation in other neuropathic conditions. This research could pave the way for future studies and clinical applications, positioning transcutaneous Vagus nerve stimulation as a valuable tool in the multidisciplinary approach to managing diabetic peripheral neuropathy.
- Being tested
- Conventional physical therapy program, Sham therapy, Transcutaneous auricular vagus nerve stimulation
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapy programOther
Flexibility exercises:
Gentle passive progressive stretching and self-stretches for lower limbs selected muscles.
Muscle strengthening (using a variety of modes as appropriate e.g. isometric, graded weight progression, open and close chain) Aerobic activity. Posture and balance training (for falls prevention and stability). Gait (can improve proprioception and gait pattern in patients with diabetic neuropathy
Sham therapyDevice
A sterile cotton ball will be placed in the ear after sterilizing the cavum conchae and cymba conchae with 75% alcohol. The stimulation electrode will be inserted into the cotton ball, and then the cotton ball will be fixed after ensuring that the stimulator does not touch the skin; the lead wire will be connected. The therapeutic apparatus will be turned on, and the parameters will be the same as those for the transcutaneous vagus nerve stimulation group. All patients will see the lights flashing when the stimulator is running
Transcutaneous auricular vagus nerve stimulationDevice
The antihelix and cymba concha will be sterilized with 75% alcohol, and then the nerve stimulation electrode (the ear clips) will be attached. The positive pole of the lead will be connected to the antihelix, and the negative pole will be connected to the cymba concha The device parameters include a wave width of 0.2 ms ± 30% and a pulse frequency of 20 Hz. Current intensity will gradually increase to a tolerable level of 4-6 mA, with stimulation lasting for 30 minutes. Heart rates of participants will be monitored continuously, with stimulation ceasing if rates drop below 50 beats per minute. Both the study and control groups will receive the same conventional physical therapy program.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Vagus nerve stimulation | Experimental | Patients will receive the same traditional physical therapy as in traditional physical therapy group in addition to 30 min of transcutaneous auricular vagus nerve stimulation 5 sessions per week for 6 weeks. Receives: Other: Conventional physical therapy program; Device: Transcutaneous auricular vagus nerve stimulation |
| traditional physical therapy | Active comparator | Patients will receive 30 min of traditional physical therapy, and 30 min of placebo Non-Invasive vagus nerve stimulation, 5 sessions per week for 6 weeks Receives: Other: Conventional physical therapy program; Device: Sham therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain intensity
The Neuropathic Pain Questionnaire-Short Form consists of 3 items assessing tingling pain, numbness, and increased pain due to touch. Patients rate each item on a scale from 0 (no pain) to 100 (worst imaginable pain/greatest intensity). translated version of Neuropathic Pain Questionnaire-Short Form is reliable and valid for use, to evaluate and diagnose neuropathic pain among Arabic-speaking patients
Measured: at baseline and after 6 weeks.
Secondary outcomes (7)
assessment of sensory nerve action optential.
nerve conduction studies is one of the gold standard techniques for diagnosing diabetic poly neuropathy Neuropack Nihon Kohden, Model MEB- 9400, Serial number:00218. (Figure The device is used for electrodiagnosis of diabetic peripheral neuropathy. It is used to measure the sensory nerve action optential.
Measured: at baseline and after 6 weeks.
assessment of sensory nerve conduction velocity of lower limb
nerve conduction studies is one of the gold standard techniques for diagnosing diabetic poly neuropathy Neuropack Nihon Kohden, Model MEB- 9400, Serial number:00218. (Figure The device is used for electrodiagnosis of diabetic peripheral neuropathy. It is used to measure the Sensory conduction velocity
Measured: at baseline and after 6 weeks.
assessment of Sensory distal latency of lower limb
nerve conduction studies is one of the gold standard techniques for diagnosing diabetic poly neuropathy Neuropack Nihon Kohden, Model MEB- 9400, Serial number:00218. (Figure The device is used for electrodiagnosis of diabetic peripheral neuropathy. It is used to measure the Sensory distal latency
Measured: at baseline and after 6 weeks.
assessment of lower limb functional scale
is a widely used patient-reported questionnaire with 20 items to assess difficulty with daily activities due to lower limb problems, scoring from 0 (extreme difficulty) to 4 (no difficulty) for each item, totaling 0-80 points, with higher scores indicating better function.
Measured: at baseline and after 6 weeks.
assessment of motor nerve conduction velocity of lower limb
nerve conduction studies is one of the gold standard techniques for diagnosing diabetic poly neuropathy Neuropack Nihon Kohden, Model MEB- 9400, Serial number:00218. (Figure The device is used for electrodiagnosis of diabetic peripheral neuropathy. It is used to measure the motor conduction velocity.
Measured: at baseline and after 6 weeks.
assessment of motor distal latency
nerve conduction studies is one of the gold standard techniques for diagnosing diabetic poly neuropathy Neuropack Nihon Kohden, Model MEB- 9400, Serial number:00218. (Figure The device is used for electrodiagnosis of diabetic peripheral neuropathy. It is used to measure the motor distal latency
Measured: at baseline and after 6 weeks.
assessment of motor nerve action optential.
nerve conduction studies is one of the gold standard techniques for diagnosing diabetic poly neuropathy Neuropack Nihon Kohden, Model MEB- 9400, Serial number:00218. (Figure The device is used for electrodiagnosis of diabetic peripheral neuropathy. It is used to measure the motor nerve action optential.
Measured: at baseline and after 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Jan 2026
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Vagal Nerve Stimulation (tVNS)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Mamdouh Nematallah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405021
- Sponsor's protocol ID
- P.T.REC/012/005474
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- P.T.REC/012/005474
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 12 Feb 2026 (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 evaluate the efficacy of vagus nerve stimulation in reducing neuropathic pain, symptom severity, electrophysiological studies and functional outcomes in patients with diabetic peripheral neuropathy.
Detailed description
Diabetes is a major global health problem affecting half a billion people worldwide. Its global prevalence is rising at an alarming rate and has been forecast to reach 700 million by 2045. Diabetic neuropathy is an important and common complication of diabetes, with a lifetime prevalence of more than 50% among people with diabetes. Diabetic neuropathy is an insidious and often disabling disease.
Sensory symptoms are diverse, ranging from numbness to dysesthesia, pain and allodynia, and typically begin in the feet and spread proximally. Motor function can also be affected, preventing patients from engaging in activities of daily living. More recently, the considerable psychosocial and quality of life impacts of Diabetic neuropathy have been recognized. Furthermore, Diabetic neuropathy is a major risk factor for diabetic foot ulceration, which is an independent risk factor for lower limb amputation and mortality. The associated economic burden is high; the annual cost of managing Diabetic neuropathy exceeds billions of dollars in different countries .
Current treatments are purely symptomatic and the most commonly recommended first-line agents include anticonvulsants (gabapentin and pregabalin), serotonin-noradrenaline reuptake inhibitors, and tricyclic antidepressants. Unfortunately, the therapeutic effect may offset by intolerable adverse effects.
In this study, evidence for a potentially effective, non-pharmacological treatment option for Diabetic neuropathy will be provided. Positive findings could lead to improved management strategies for Diabetic neuropathy, reducing the burden of chronic pain and enhancing the overall well-being of diabetic patients. Vagus nerve stimulation has emerged as a potential intervention, offering promise in modulating neuropathic pain and improving functional outcomes.
Furthermore, understanding the mechanisms through which transcutaneous Vagus nerve stimulation affects pain and nerve function may offer insights into broader applications of vagus nerve stimulation in other neuropathic conditions. This research could pave the way for future studies and clinical applications, positioning transcutaneous Vagus nerve stimulation as a valuable tool in the multidisciplinary approach to managing diabetic peripheral neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Vagus nerve stimulation | Experimental | Other: Conventional physical therapy program, Device: Transcutaneous auricular vagus nerve stimulationPatients will receive the same traditional physical therapy as in traditional physical therapy group in addition to 30 min of transcutaneous auricular vagus nerve stimulation 5 sessions per week for 6 weeks. |
| traditional physical therapy | Active comparator | Other: Conventional physical therapy program, Device: Sham therapyPatients will receive 30 min of traditional physical therapy, and 30 min of placebo Non-Invasive vagus nerve stimulation, 5 sessions per week for 6 weeks |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Conventional physical therapy programFlexibility exercises: Gentle passive progressive stretching and self-stretches for lower limbs selected muscles. Muscle strengthening (using a variety of modes as appropriate e.g. isometric, graded weight progression, open and close chain) Aerobic activity. Posture and balance training (for falls prevention and stability). Gait (can improve proprioception and gait pattern in patients with diabetic neuropathy | Other | Transcutaneous Vagus nerve stimulation, traditional physical therapy |
| Sham therapyA sterile cotton ball will be placed in the ear after sterilizing the cavum conchae and cymba conchae with 75% alcohol. The stimulation electrode will be inserted into the cotton ball, and then the cotton ball will be fixed after ensuring that the stimulator does not touch the skin; the lead wire will be connected. The therapeutic apparatus will be turned on, and the parameters will be the same as those for the transcutaneous vagus nerve stimulation group. All patients will see the lights flashing when the stimulator is running | Device | traditional physical therapy |
| Transcutaneous auricular vagus nerve stimulationThe antihelix and cymba concha will be sterilized with 75% alcohol, and then the nerve stimulation electrode (the ear clips) will be attached. The positive pole of the lead will be connected to the antihelix, and the negative pole will be connected to the cymba concha The device parameters include a wave width of 0.2 ms ± 30% and a pulse frequency of 20 Hz. Current intensity will gradually increase to a tolerable level of 4-6 mA, with stimulation lasting for 30 minutes. Heart rates of participants will be monitored continuously, with stimulation ceasing if rates drop below 50 beats per minute. Both the study and control groups will receive the same conventional physical therapy program. | Device | Transcutaneous Vagus nerve stimulation |
Primary outcome
Assessment of pain intensity
Time frame: at baseline and after 6 weeks.
The Neuropathic Pain Questionnaire-Short Form consists of 3 items assessing tingling pain, numbness, and increased pain due to touch. Patients rate each item on a scale from 0 (no pain) to 100 (worst imaginable pain/greatest intensity). translated version of Neuropathic Pain Questionnaire-Short Form is reliable and valid for use, to evaluate and diagnose neuropathic pain among Arabic-speaking patients
7 secondary outcomes
assessment of sensory nerve action optential.
Time frame: at baseline and after 6 weeks.
assessment of sensory nerve conduction velocity of lower limb
Time frame: at baseline and after 6 weeks.
assessment of Sensory distal latency of lower limb
Time frame: at baseline and after 6 weeks.
assessment of lower limb functional scale
Time frame: at baseline and after 6 weeks.
assessment of motor nerve conduction velocity of lower limb
Time frame: at baseline and after 6 weeks.
assessment of motor distal latency
Time frame: at baseline and after 6 weeks.
assessment of motor nerve action optential.
Time frame: at baseline and after 6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physical therapy program and Transcutaneous auricular vagus nerve stimulation in people with Transcutaneous Vagal Nerve Stimulation (tVNS) and Diabetic Polyneuropathy, run by Cairo 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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 12 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hoda Mamdouh nematallah, assisstant lecturer (01096551775, hmamdouh@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain intensity (time frame: at baseline and after 6 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 12 Feb 2026.