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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHuazhong University of Science and Technology

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Brain Stimulation + Usual CareExperimental treatment 1 intervention
Group B: Sham Stimulation + Usual CareSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Pain Intensity (NRS)

Numeric Rating Scale (NRS, 0-10); change from baseline in pain intensity.

Time frame
Baseline, Day 10 (end of treatment), 1 month, and 3 months

Secondary outcomes

1

Neuropathic pain symptoms

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

Time frame
Baseline, Day 10, 1 month, 3 months
2

Pain interference

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

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

Health-related quality of life

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

Time frame
Baseline, Day 10, 1 month, 3 months
4

Sleep quality

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

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

Other outcomes

Sponsors and contacts

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