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Search / Trial NCT06890897

Esketamine Combined Pulsed Radiofrequency for Acute/Subacute Zoster-associated Trigeminal Neuralgia

Launched by BEIJING TIANTAN HOSPITAL · Mar 20, 2025

Trial Information

Current as of April 29, 2025

Recruiting

Keywords

Acute/Subacute Zoster Associated Trigeminal Neuralgia Esketamine Pulsed Radiofrequency

ClinConnect Summary

This clinical trial is studying a combination of esketamine and a treatment called pulsed radiofrequency to help reduce pain in patients suffering from a specific type of nerve pain known as trigeminal neuralgia, which can occur after shingles (a viral infection). The goal is to see how effective and safe this combination treatment is over one month for people who have had shingles within the last three months and have moderate to severe pain despite taking regular medications.

To be eligible for this trial, participants must be over 18 years old and have experienced shingles-related pain in the facial area. They should rate their pain at 4 or higher on a scale of 0 to 10, where 0 means no pain and 10 means the worst possible pain. However, there are certain health conditions that would exclude someone from participating, such as severe sleep apnea or a history of serious health issues. If someone joins the study, they can expect to undergo a specific procedure to help manage their pain while being closely monitored for any side effects. This trial is not yet recruiting, but it aims to provide new options for those struggling with this painful condition.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age \>18 years;
  • 2. History of HZ within the last three months;
  • 3. Lesions located in the trigeminal nerve or its branches innervated regions;
  • 4. Numeric Rating Scale (NRS) pain score≥4 (NRS, 0 = no pain, 10= worst possible pain) with pharmacotherapy;
  • 5. Planned to perform CT-guided PRF treatment of the Gasserian ganglion .
  • Exclusion Criteria:
  • 1. Obstructive sleep apnoea syndrome;
  • 2. Those who receive other invasive treatments, such as spinal cord stimulation;
  • 3. A history of systemic immune diseases, organ transplantation, or cancers;
  • 4. A history of severe cardiopulmonary, hepatic or renal dysfunction;
  • 5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
  • 6. Comorbid hyperthyroidism or phaeochromocytoma;
  • 7. Recent history of drug abuse;
  • 8. Having contraindications to esketamine;
  • 9. Communication difficulties.
  • Withdrawal criteria
  • 1. Lost to follow-up during the study;
  • 2. Not perform the planned operation;
  • 3. Receiving other treatment regimes during the study period;
  • 4. Not suitable for continuing the study for emerging severe comorbidities or special physiological changes during the study;
  • 5. Voluntary withdrawal from the study.

About Beijing Tiantan Hospital

Beijing Tiantan Hospital, affiliated with Capital Medical University, is a leading medical institution in China renowned for its expertise in neurology, neurosurgery, and various other specialties. As a prominent clinical trial sponsor, the hospital is committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on high-quality clinical trials, Beijing Tiantan Hospital adheres to rigorous ethical standards and regulatory requirements, fostering collaboration with academic institutions and industry partners to facilitate the development of cutting-edge therapies and interventions. Its state-of-the-art facilities and experienced research team enable the hospital to play a pivotal role in the global medical research landscape.

Locations

Beijing, , China

Patients applied

0 patients applied

Trial Officials

Fang Luo, M.D.

Principal Investigator

Beijing Tiantan Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported