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Not Yet RecruitingNCT07352553

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
Phase
N/A
Study type
Interventional
Enrollment
94 (estimated)
Sponsor
Huazhong University of Science and Technology · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICENon-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.
DEVICESham 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.

Timeline

Start date
2026-01-20
Primary completion
2026-06-30
Completion
2026-07-30
First posted
2026-01-20
Last updated
2026-01-20

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07352553. Inclusion in this directory is not an endorsement.