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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Change in Pain Intensity (NRS) [Срок оценки: Baseline, Day 10 (end of treatment), 1 month, and 3 months]

Вторичные конечные точки (6)

• Neuropathic pain symptoms [Срок оценки: Baseline, Day 10, 1 month, 3 months]
• Pain interference [Срок оценки: Baseline, Day 10, 1 month, 3 months]
• Health-related quality of life [Срок оценки: Baseline, Day 10, 1 month, 3 months]
• Sleep quality [Срок оценки: Baseline, Day 10, 1 month, 3 months]
• Emotional status [Срок оценки: Baseline, Day 10, 1 month, 3 months]
• Global impression [Срок оценки: Day 10, 1 month, 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji hospital — Ухань

Публикации

• 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

Идентификаторы

NCT: NCT07352553 · TJ-IRB202512160

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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