NCT07405021

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

January 27, 2026

Last Update Submit

February 9, 2026

Conditions

Transcutaneous Vagal Nerve Stimulation (tVNS)Diabetic Polyneuropathy

Outcome Measures

Primary Outcomes (1)

  • 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

    at baseline and after 6 weeks.

Secondary Outcomes (7)

  • assessment of sensory nerve action optential.

    at baseline and after 6 weeks.

  • assessment of sensory nerve conduction velocity of lower limb

    at baseline and after 6 weeks.

  • assessment of Sensory distal latency of lower limb

    at baseline and after 6 weeks.

  • assessment of lower limb functional scale

    at baseline and after 6 weeks.

  • assessment of motor nerve conduction velocity of lower limb

    at baseline and after 6 weeks.

  • +2 more secondary outcomes

Study Arms (2)

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.

Other: Conventional physical therapy programDevice: 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

Other: Conventional physical therapy programDevice: Sham therapy

Interventions

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

Transcutaneous Vagus nerve stimulationtraditional physical therapy
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

traditional physical therapy
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.

Transcutaneous Vagus nerve stimulation

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify 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.
  • 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.

You may not qualify 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.
  • Foot deformities or active foot ulcers.
  • History of lower limb surgical operations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

outpatient clinic, faculty of physical therapy, Horus university

Damietta, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Central Study Contacts

Hoda Mamdouh nematallah, assisstant lecturer

CONTACT

01096551775hmamdouh@horus.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 12, 2026

Study Start

January 1, 2026

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations

EG(1)