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NCT Number: NCT07352553

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-invasive transcranial stimulation

Device

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 Non-invasive transcranial stimulation

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Neuropathic pain symptoms

    Time frame: Baseline, Day 10, 1 month, 3 months

    Neuropathic Pain Symptom Inventory (NPSI); change from baseline.

  2. Pain interference

    Time frame: Baseline, Day 10, 1 month, 3 months

    Brief Pain Inventory (BPI) interference subscale; change from baseline.

  3. Health-related quality of life

    Time frame: Baseline, Day 10, 1 month, 3 months

    EuroQol-5 Dimension (EQ-5D); change from baseline.

  4. Sleep quality

    Time frame: Baseline, Day 10, 1 month, 3 months

    Medical Outcomes Study Sleep Scale (MOS-SS); change from baseline.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xianwei Zhang, Doctor

CONTACT

[email protected]

13296696810

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Acronym: PHN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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