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

NCT07352553 | Not Yet Recruiting

• 1 other identifier: TJ-IRB202512160
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity (NRS)

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

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

Secondary Outcomes (6)

• Neuropathic pain symptoms

  Baseline, Day 10, 1 month, 3 months

• Pain interference

  Baseline, Day 10, 1 month, 3 months

• Health-related quality of life

  Baseline, Day 10, 1 month, 3 months

• Sleep quality

  Baseline, Day 10, 1 month, 3 months

• Emotional status

  Baseline, Day 10, 1 month, 3 months

Study Arms (2)

Brain Stimulation + Usual Care

EXPERIMENTAL

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

Sham Stimulation + Usual Care

SHAM COMPARATOR

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

Interventions

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.

Sham Stimulation + Usual Care

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.

Brain Stimulation + Usual Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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; discussion 770. doi: 10.1227/01.NEU.0000325731.46702.D9.

  PMID: 18981888 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Holmes D. The pain drain. Nature. 2016 Jul 14;535(7611):S2-3. doi: 10.1038/535S2a. No abstract available.

  PMID: 27410529 BACKGROUND

• Scholz J, Finnerup NB, Attal N, Aziz Q, Baron R, Bennett MI, Benoliel R, Cohen M, Cruccu G, Davis KD, Evers S, First M, Giamberardino MA, Hansson P, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Nurmikko T, Perrot S, Raja SN, Rice ASC, Rowbotham MC, Schug S, Simpson DM, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ, Barke A, Rief W, Treede RD; Classification Committee of the Neuropathic Pain Special Interest Group (NeuPSIG). The IASP classification of chronic pain for ICD-11: chronic neuropathic pain. Pain. 2019 Jan;160(1):53-59. doi: 10.1097/j.pain.0000000000001365.

  PMID: 30586071 BACKGROUND

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xianwei Zhang, Doctor

CONTACT

13296696810; ourpain@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CN (1)