Brain Stimulation for Postherpetic Neuralgia: A Randomized Sham-Controlled Trial (PHN)

January 11, 2026 updated by: Xianwei Zhang，MD, Huazhong University of Science and Technology

Non-invasive Brain Stimulation for Postherpetic Neuralgia: A Prospective, Randomized, Sham-Controlled Study

Pharmacotherapy is the cornerstone of Postherpetic Neuralgia (PHN) management. First-line treatments for PHN include antiviral agents (e.g., acyclovir, valacyclovir, famciclovir, and brivudine), centrally acting antiepileptic drugs (pregabalin and gabapentin), antidepressants (duloxetine and venlafaxine), and peripherally acting sodium-channel blockers (lidocaine patches).

In recent years, substantial progress has been made in the prevention and treatment of PHN, including early and active antiviral therapy (acyclovir, valacyclovir, famciclovir, brivudine, etc.), analgesic therapy (calcium-channel modulators such as pregabalin and gabapentin; tricyclic antidepressants such as amitriptyline; and opioid analgesics), interventional procedures (e.g., radiofrequency modulation and spinal cord stimulation), and vaccination. Nevertheless, clinical outcomes remain unsatisfactory, with the incidence of refractory PHN still exceeding 50%. Adverse effects associated with certain first- and second-line medications (such as antidepressants and anticonvulsants), as well as the potential risk of opioid dependence, markedly reduce treatment adherence. This situation has compelled clinicians to continually seek new and effective therapeutic approaches for PHN.

Non-invasive transcranial stimulation, as an emerging noninvasive neuromodulation technique, enables targeted modulation of deep brain structures. Animal studies have demonstrated that it can noninvasively regulate neuronal firing in deep regions and induce long-term plasticity, while offering relatively high spatial selectivity and tissue penetration. These features suggest broad clinical potential in chronic pain and affective disorders.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xianwei Zhang, Doctor
  • Phone Number: 13296696810
  • Email: ourpain@163.com

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosis of postherpetic neuralgia (PHN) with disease duration ≥ 3 months.
  • NRS pain score ≥ 4.
  • Willing to receive the intervention and able to provide written informed consent.

Exclusion Criteria:

  • Contraindications to electrical stimulation (e.g., intracranial metal implants, cardiac pacemaker).
  • History of epilepsy, severe psychiatric disorder, or cognitive impairment.
  • Pregnant or breastfeeding women.
  • Unable to comply with the intervention procedures and follow-up assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brain Stimulation + Usual Care
Participants receive brain stimulation in addition to usual pharmacological care for postherpetic neuralgia. Brain stimulation is delivered once daily for 30 minutes for 10 consecutive days.
Device: Non-invasive transcranial stimulation
Non-invasive transcranial stimulation is delivered once daily for 30 minutes for 10 consecutive days. Stimulation is administered using a multi-channel battery-powered device with five circular Ag/AgCl electrodes; current output is monitored in real time for safety.
Sham Comparator: Sham Stimulation + Usual Care
Participants receive sham stimulation in addition to usual pharmacological care. Electrodes are applied once daily for 30 minutes for 10 consecutive days; after an initial brief stimulation to mimic sensation, the output is turned off.
Device: Sham Non-invasive transcranial stimulation
Sham procedure with identical electrode placement and session duration (30 minutes once daily for 10 consecutive days). After an initial brief stimulation to mimic sensation, the current output is turned off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity (NRS)
Time Frame: Baseline, Day 10 (end of treatment), 1 month, and 3 months
Numeric Rating Scale (NRS, 0-10); change from baseline in pain intensity.
Baseline, Day 10 (end of treatment), 1 month, and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic pain symptoms
Time Frame: Baseline, Day 10, 1 month, 3 months
Neuropathic Pain Symptom Inventory (NPSI); change from baseline.
Baseline, Day 10, 1 month, 3 months
Pain interference
Time Frame: Baseline, Day 10, 1 month, 3 months
Brief Pain Inventory (BPI) interference subscale; change from baseline.
Baseline, Day 10, 1 month, 3 months
Health-related quality of life
Time Frame: Baseline, Day 10, 1 month, 3 months
EuroQol-5 Dimension (EQ-5D); change from baseline.
Baseline, Day 10, 1 month, 3 months
Sleep quality
Time Frame: Baseline, Day 10, 1 month, 3 months
Medical Outcomes Study Sleep Scale (MOS-SS); change from baseline.
Baseline, Day 10, 1 month, 3 months
Emotional status
Time Frame: Baseline, Day 10, 1 month, 3 months
Generalized Anxiety Disorder-7 (GAD-7); change from baseline.Edinburgh Postnatal Depression Scale-10 (EPDS-10) or prespecified depression scale; change from baseline.Pain Catastrophizing Scale (PCS); change from baseline.
Baseline, Day 10, 1 month, 3 months
Global impression
Time Frame: Day 10, 1 month, 3 months
Patient Global Impression of Change (PGIC) and Clinician Global Impression of Change (CGIC) at follow-up visits.
Day 10, 1 month, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 20, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB202512160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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