Transcutaneous Auricular Vagus Nerve Stimulation on Post-Herpetic Neuralgia

NCT07123987 | Recruiting

• 1 other identifier: P.T.REC/012/005412
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the therapeutic efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) in the treatment of patients with post-herpetic neuralgia (PHN). Participants will receive taVNS in addition to standard care. The study aims to determine whether taVNS can provide significant pain relief and improve quality of life in PHN patients.

Conditions

Post Herpetic Neuralgia (PHN)

Keywords

Post-Herpetic Neuralgia; Neuropathic Pain; Herpes Zoster; Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Non-invasive Neuromodulation; Chronic Pain Management; Pain Relief; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory - Short Form (BPI-SF)

  the Brief Pain Inventory-Short Form (BPI SF) is a valuable tool for assessing pain severity and its impact on daily functioning on a 0-10 numeric rating scale, with higher scores indicating more severe pain.

  Administered three times: before the first treatment session, after 2 weeks, and after 4 weeks. Administration mode: Interview-based.

Secondary Outcomes (1)

• Short form McGill pain questionnaire 2 (SF-MPQ-2)

  Administered three times: before the first treatment session, after 2 weeks, and after 4 weeks. Administration mode: Interview-based.

Study Arms (2)

Group (A): Study group

EXPERIMENTAL

this group will receive taVNS in addition to traditional medical treatment

Device: transcutaneous auricular vagus nerve stimulation (taVNS)

Group (B): Control group

ACTIVE COMPARATOR

this group will receive the same traditional medical treatment only

Other: traditional medical treatment for PHN

Interventions

traditional medical treatment for PHN OTHER

Standard medical treatment for post-herpetic neuralgia as per current clinical guidelines, without the application of taVNS device.

Group (B): Control group

transcutaneous auricular vagus nerve stimulation (taVNS) DEVICE

Use of the EV-906 device with TENS ear clips for transcutaneous auricular vagus nerve stimulation (taVNS), applied according to the study protocol, in addition to standard medical treatment for post-herpetic neuralgia. This device meets ISO 13485, FDA QSR, and CE standards

Group (A): Study group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 35-65 years diagnosed with PHN. Persistent pain for at least 3 months after herpes zoster infection. Only patients who sign the informed consent form will be included.

You may not qualify if:

• Contraindications to taVNS such as:
• pregnancy;
• active implants (e.g., pacemakers, cochlear implants) or brain shunts;
• previous neurological or psychiatric diagnoses;
• history of addiction or substance abuse;
• history of trauma and/or brain surgery;
• cardiac disease;
• acute or chronic use of medications and/or illicit drugs;
• susceptibility to headaches and seizures. Severe cognitive impairment. Other chronic pain conditions.

Sponsors & Collaborators

• Mohamed Hosny Ismail Easa: lead

Study Sites (1)

Faculty of Physical Therapy - Cairo University

Cairo, Giza Governorate, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Neuralgia, Postherpetic; Neuralgia; Herpes Zoster

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Wafaa Hussein Borhan, PhD

  Professor of Physical Therapy for Surgery Department, Faculty of Physical Therapy, Cairo University

  STUDY CHAIR

• Rofaida El Sayed El Naggar, MD

  Lecturer of Dermatology, Kasr Alainy, Faculty of Medicine, Cairo University

  STUDY DIRECTOR

• Doaa Atef Aly, PhD

  Lecturer of Physical Therapy for Surgery Department, Faculty of Physical Therapy, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Hosny Ismail Easa, MSc, PT

CONTACT

+201144736266; drhosnypt99@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, MSc Candidate, Faculty of Physical Therapy, Cairo University

Model Details: Thirty-four male and female patients diagnosed with PHN, aged between 35 and 65 years, will be randomly allocated into two equal groups, each containing 17 patients: Group (A): Study group - This group will receive taVNS in addition to traditional medical treatment. Group (B): Control group - This group will receive the same traditional medical treatment only.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 15, 2025
• Study Start: September 7, 2025
• Primary Completion (Estimated): September 9, 2026
• Study Completion (Estimated): September 9, 2026
• Last Updated: March 18, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)