Brain Stimulation for Postherpetic Neuralgia: A Randomized Sham-Controlled Trial
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: Non-invasive transcranial stimulation, Sham Non-invasive transcranial stimulation.
- Who it may be relevant to
- Registry conditions: Postherpetic Neuralgia. Basic parameters: 18 years — 80 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
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Non-invasive Brain Stimulation for Postherpetic Neuralgia: A Prospective, Randomized, Sham-Controlled Study
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Change in Pain Intensity (NRS) [Time frame: Baseline, Day 10 (end of treatment), 1 month, and 3 months]
Secondary outcome measures (6)
- Neuropathic pain symptoms [Time frame: Baseline, Day 10, 1 month, 3 months]
- Pain interference [Time frame: Baseline, Day 10, 1 month, 3 months]
- Health-related quality of life [Time frame: Baseline, Day 10, 1 month, 3 months]
- Sleep quality [Time frame: Baseline, Day 10, 1 month, 3 months]
- Emotional status [Time frame: Baseline, Day 10, 1 month, 3 months]
- Global impression [Time frame: Day 10, 1 month, 3 months]
Eligibility criteria
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.
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
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tongji hospital — Wuhan
Publications
- Jia T, Xia J, Zhang C, Sun B, Yuan K, Liu T, Xu X, Liu J. Comparing analgesic effects of temporal interference stimulation on ventral posterolateral thalamus and high-definition transcranial alternating current stimulation on sensorimotor cortex during sustained experimental pain. Brain Stimul. 2025 May-Jun;18(3):701-703. doi: 10.1016/j.brs.2025.03.013. Epub 2025 Mar 19. No abstract available. PMID 40112912
- Grossman N, Okun MS, Boyden ES. Translating Temporal Interference Brain Stimulation to Treat Neurological and Psychiatric Conditions. JAMA Neurol. 2018 Nov 1;75(11):1307-1308. doi: 10.1001/jamaneurol.2018.2760. No abstract available. PMID 30264149
- Kurklinsky S, Palmer SC, Arroliga MJ, Ghazi SM. Neuromodulation in Postherpetic Neuralgia: Case Reports and Review of the Literature. Pain Med. 2018 Jun 1;19(6):1237-1244. doi: 10.1093/pm/pnx175. PMID 29016994
- Plow EB, Pascual-Leone A, Machado A. Brain stimulation in the treatment of chronic neuropathic and non-cancerous pain. J Pain. 2012 May;13(5):411-24. doi: 10.1016/j.jpain.2012.02.001. Epub 2012 Apr 7. PMID 22484179
- Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008 Oct;63(4):762-70; disc PMID 18981888
- Sears NC, Machado AG, Nagel SJ, Deogaonkar M, Stanton-Hicks M, Rezai AR, Henderson JM. Long-term outcomes of spinal cord stimulation with paddle leads in the treatment of complex regional pain syndrome and failed back surgery syndrome. Neuromodulation. 2011 Jul-Aug;14(4):312-8; discussion 318. doi: 10.1111/j.1525-1403.2011.00372.x. Epub 2011 Jul 7. PMID 21992424
- Shrestha M, Chen A. Modalities in managing postherpetic neuralgia. Korean J Pain. 2018 Oct;31(4):235-243. doi: 10.3344/kjp.2018.31.4.235. Epub 2018 Oct 1. PMID 30310548
- van Hecke O, Austin SK, Khan RA, Smith BH, Torrance N. Neuropathic pain in the general population: a systematic review of epidemiological studies. Pain. 2014 Apr;155(4):654-662. doi: 10.1016/j.pain.2013.11.013. Epub 2013 Nov 26. PMID 24291734
Identifiers
NCT: NCT07352553 · TJ-IRB202512160