Transcutaneous Auricular Vagus Nerve Stimulation on Post-Herpetic Neuralgia

NCT ID: NCT07123987

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-03-01

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.

Detailed Description

Post-herpetic neuralgia (PHN) is a chronic neuropathic pain condition that persists for months or years following the resolution of herpes zoster (HZ) infection. It is characterized by persistent burning, stabbing, or shooting pain, often accompanied by allodynia and hyperalgesia, which can significantly impair quality of life. Current treatment options for PHN, including pharmacological therapies, often provide incomplete pain relief and are associated with side effects, creating a need for novel, non-invasive interventions.

This randomized controlled trial aims to evaluate the therapeutic efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) as an adjunct to standard medical treatment for patients with PHN. The vagus nerve plays a crucial role in modulating pain perception and inflammatory processes, and its non-invasive stimulation through the auricular branch has shown promising analgesic effects in various chronic pain syndromes.

A total of 34 male and female participants, aged 35-65 years, diagnosed with PHN will be randomly allocated into two equal groups (17 participants per group). Group A (Experimental) will receive taVNS in addition to conventional pharmacological management, while Group B (Control) will receive conventional pharmacological management alone. The taVNS intervention will be delivered using the EV-906 device with TENS ear clips, applied according to the study protocol and safety standards (ISO 13485, FDA QSR, and CE compliance).

Pain intensity and quality will be assessed at baseline, after two weeks, and after four weeks using validated outcome measures: the Brief Pain Inventory (BPI) short form and the Short-form McGill Pain Questionnaire-2 (SF-MPQ-2). The primary outcome is the change in pain severity scores, and the secondary outcome is the change in pain interference with daily activities.

The results of this study will provide evidence regarding the clinical utility of taVNS as a safe, non-invasive, and effective adjunct therapy for PHN, with the potential to improve patient outcomes and quality of life

Conditions

Post Herpetic Neuralgia (PHN)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group (A): Study group

this group will receive taVNS in addition to traditional medical treatment

Group Type: EXPERIMENTAL

transcutaneous auricular vagus nerve stimulation (taVNS)

Intervention Type: 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 (B): Control group

this group will receive the same traditional medical treatment only

Group Type: ACTIVE_COMPARATOR

traditional medical treatment for PHN

Intervention Type: OTHER

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

Interventions

transcutaneous auricular vagus nerve stimulation (taVNS)

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

Intervention Type: DEVICE

traditional medical treatment for PHN

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

Contraindications to taVNS such as:

1. pregnancy;

2. active implants (e.g., pacemakers, cochlear implants) or brain shunts;

3. previous neurological or psychiatric diagnoses;

4. history of addiction or substance abuse;

5. history of trauma and/or brain surgery;

6. cardiac disease;

7. acute or chronic use of medications and/or illicit drugs;

8. susceptibility to headaches and seizures. Severe cognitive impairment. Other chronic pain conditions.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mohamed Hosny Ismail Easa

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Hosny Ismail Easa

Principal Investigator, MSc Candidate, Faculty of Physical Therapy, Cairo University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wafaa Hussein Borhan, PhD

Role: STUDY_CHAIR

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

Rofaida El Sayed El Naggar, MD

Role: STUDY_DIRECTOR

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

Doaa Atef Aly, PhD

Role: STUDY_DIRECTOR

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

Locations

Faculty of Physical Therapy - Cairo University

Cairo, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed Hosny Ismail Easa, MSc, PT

Role: CONTACT

drhosnypt99@gmail.com

+201144736266

Facility Contacts

Mohamed Hosny Ismail Easa, MSc, PT

Role: primary

drhosnypt99@gmail.com

+201144736266

Other Identifiers

P.T.REC/012/005412

Identifier Type: -

Identifier Source: org_study_id