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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07352553
Acronym
PHN
Enrollment
94
Registered
2026-01-20
Start date
2026-01-20
Completion date
2026-07-30
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postherpetic Neuralgia

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.

Interventions

DEVICENon-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.

DEVICESham 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.

Sponsors

Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Intensity (NRS)Baseline, Day 10 (end of treatment), 1 month, and 3 monthsNumeric Rating Scale (NRS, 0-10); change from baseline in pain intensity.

Secondary

MeasureTime frameDescription
Neuropathic pain symptomsBaseline, Day 10, 1 month, 3 monthsNeuropathic Pain Symptom Inventory (NPSI); change from baseline.
Pain interferenceBaseline, Day 10, 1 month, 3 monthsBrief Pain Inventory (BPI) interference subscale; change from baseline.
Health-related quality of lifeBaseline, Day 10, 1 month, 3 monthsEuroQol-5 Dimension (EQ-5D); change from baseline.
Sleep qualityBaseline, Day 10, 1 month, 3 monthsMedical Outcomes Study Sleep Scale (MOS-SS); change from baseline.
Emotional statusBaseline, Day 10, 1 month, 3 monthsGeneralized 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.
Global impressionDay 10, 1 month, 3 monthsPatient Global Impression of Change (PGIC) and Clinician Global Impression of Change (CGIC) at follow-up visits.

Countries

China

Contacts

CONTACTXianwei Zhang, Doctor
ourpain@163.com13296696810

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026