Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:33 PM
Ignite Modification Date:
2025-12-24 @ 12:33 PM
NCT ID:
NCT06290661
Eligibility Criteria:
Inclusion criteria:
* 18 years old and above, male or female
* Diagnosed by trained clinical doctors as postherpetic neuralgia, which is an indication for peripheral nerve stimulation therapy;
* Assess the damage or disease of the peripheral sensory system through the four questions of Douleur Neuropathy before surgery;
* The subject has received conventional treatment but the efficacy is poor, or cannot tolerate the side effects of conventional treatment;
* Visual analogue scale for pain within 24 hours before surgery ≥ 5;
* The subjects are able to understand the purpose of this study, have sufficient compliance with the research treatment, and are willing to sign an informed consent form;
Exclusion criteria:
* Subjects who need to receive both radio frequency modulation and intrathecal drug infusion treatment simultaneously;
* Subjects who are known to have cardiac implants (pacemakers or defibrillators) or other implantable neural stimulators (spinal cord stimulators or deep brain stimulators, etc.);
* Subjects with severe psychological and/or mental disorders and/or non therapeutic drug dependence;
* Subjects expected to undergo MRI examination within 30 days after PNS implantation;
* Expected to be discharged within 48 hours or less;
* Target nerve damage or muscle defects in known pain areas;
* Subjects who are known to be allergic to skin contact materials (tape or adhesive);
* Allergy to anesthetics such as lidocaine;
* Concomitant severe heart disease, liver disease, kidney disease, respiratory system disease, and coagulation dysfunction;
* Pregnant women, lactating women, or women planning to have children within the next three months;
* Subjects who have participated in any other clinical trial, or who may participate in any other trial after enrollment;
* Other situations that the researcher deems unsuitable for participation in this clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06290661
Study Brief:
Protocol Section:
NCT06290661