Postherpetic NeuralgiaPHNNCT07352553
Brain Stimulation for Postherpetic Neuralgia: A Randomized Sham-Controlled Trial
A study testing Non-invasive transcranial stimulation in people with Postherpetic Neuralgia, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- Non-invasive transcranial stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji hospital
Wuhan, Hubei, 430030
Xianwei Zhang, 13296696810, ourpain@163.com
About this study
Official title: Non-invasive Brain Stimulation for Postherpetic Neuralgia: A Prospective, Randomized, Sham-Controlled Study
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
- Being tested
- Non-invasive transcranial stimulation, Sham Non-invasive transcranial stimulation
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive transcranial stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Non-invasive transcranial stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity (NRS)
Numeric Rating Scale (NRS, 0-10); change from baseline in pain intensity.
Measured: Baseline, Day 10 (end of treatment), 1 month, and 3 months
Secondary outcomes (6)
Neuropathic pain symptoms
Neuropathic Pain Symptom Inventory (NPSI); change from baseline.
Measured: Baseline, Day 10, 1 month, 3 months
Pain interference
Brief Pain Inventory (BPI) interference subscale; change from baseline.
Measured: Baseline, Day 10, 1 month, 3 months
Health-related quality of life
EuroQol-5 Dimension (EQ-5D); change from baseline.
Measured: Baseline, Day 10, 1 month, 3 months
Sleep quality
Medical Outcomes Study Sleep Scale (MOS-SS); change from baseline.
Measured: Baseline, Day 10, 1 month, 3 months
Emotional status
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.
Measured: Baseline, Day 10, 1 month, 3 months
Global impression
Patient Global Impression of Change (PGIC) and Clinician Global Impression of Change (CGIC) at follow-up visits.
Measured: Day 10, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianwei Zhang，MD, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352553
- Sponsor's protocol ID
- TJ-IRB202512160
- Acronym
- PHN
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 40112912Grossman 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.
PubMed 30264149Kurklinsky 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.
PubMed 29016994Plow 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.
PubMed 22484179Kumar 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.
PubMed 18981888Sears 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.
PubMed 21992424Shrestha 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.
PubMed 30310548van 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.
PubMed 24291734Holmes D. The pain drain. Nature. 2016 Jul 14;535(7611):S2-3. doi: 10.1038/535S2a. No abstract available.
PubMed 27410529Scholz 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.
PubMed 30586071
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Brain Stimulation for Postherpetic Neuralgia: A Prospective, Randomized, Sham-Controlled Study
- ClinicalTrials.gov ID
- NCT07352553
- Acronym / sponsor ID
- PHN / TJ-IRB202512160
- Conditions
- Postherpetic Neuralgia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Stimulation + Usual Care | Experimental | Device: Non-invasive transcranial stimulationParticipants 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. |
| Sham Stimulation + Usual Care | Sham comparator | Device: Sham Non-invasive transcranial stimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive transcranial stimulationNon-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 | Brain Stimulation + Usual Care |
| Sham Non-invasive transcranial stimulationSham 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. | Device | Sham Stimulation + Usual Care |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 40112912Jia 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.
- Background: PubMed 30264149Grossman 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.
- Background: PubMed 29016994Kurklinsky 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.
- Background: PubMed 22484179Plow 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.
- Background: PubMed 18981888Kumar 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.
- Background: PubMed 21992424Sears 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.
- Background: PubMed 30310548Shrestha 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.
- Background: PubMed 24291734van 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.
- Background: PubMed 27410529Holmes D. The pain drain. Nature. 2016 Jul 14;535(7611):S2-3. doi: 10.1038/535S2a. No abstract available.
- Background: PubMed 30586071Scholz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive transcranial stimulation in people with Postherpetic Neuralgia, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianwei Zhang, Doctor (13296696810, ourpain@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (NRS) (time frame: Baseline, Day 10 (end of treatment), 1 month, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07352553, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.