Transcutaneous Auricular Vagus Nerve Stimulation on Post-Herpetic Neuralgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcutaneous auricular vagus nerve stimulation (taVNS), traditional medical treatment for PHN.
- Who it may be relevant to
- Registry conditions: Post Herpetic Neuralgia (PHN). Basic parameters: 35 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Device 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 - Other traditional medical treatment for PHN
Standard medical treatment for post-herpetic neuralgia as per current clinical guidelines, without the application of taVNS device.
Primary outcome measures
- Brief Pain Inventory - Short Form (BPI-SF) [Time frame: Administered three times: before the first treatment session, after 2 weeks, and after 4 weeks. Administration mode: Interview-based.]
Secondary outcome measures (1)
- Short form McGill pain questionnaire 2 (SF-MPQ-2) [Time frame: Administered three times: before the first treatment session, after 2 weeks, and after 4 weeks. Administration mode: Interview-based.]
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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Physical Therapy - Cairo University — Cairo
Identifiers
NCT: NCT07123987 · P.T.REC/012/005412