CompletedNot Applicable

Dorsal Root Ganglion Stimulation in Postherpetic Neuropathy

Italy77 participantsStarted 2022-08-08

Plain-language summary

This is a prospective, multicenter observational study evaluating the efficacy of ganglion stimulation (medical device) in cases of post-herpetic neuropathy. This study introduces recent methods of phenotypic stratification of postherpetic neuropathy into the field of interventional pain therapy. The aim is to identify which clinical expression of this diverse pathology can derive the greatest benefits from an otherwise effective but expensive therapy such as ganglion stimulation. The study protocol includes the application of a common clinical practice, already in use for several years at the promoting center and participating centers (as well as internationally scientifically codified). It is supported by an innovative stratification of clinical expression (phenotype of the disease), recently introduced in the literature. The study aims to identify, through careful clinical evaluation, predictive indices of the greatest success in invasive ganglion stimulation therapy, a treatment associated with significant system costs and considerable inconvenience for the patient. The results of the experimentation will allow the codification of evaluative clinical pathways to predict a higher success index in certain clinical expressions of postherpetic neuropathy compared to others. This will help reduce the costs of implant trials and enable defining the real objective of the proposed therapy in consultation with the patient.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:• * Subjects of both genders aged between 18 and 75 years; * Patients with postherpetic neuralgia (PHN) for at least 6 months who have tried the topical and systemic pharmacological therapies recommended in the neuropathic pain guidelines * Distribution of neuropathic pain in a region between C6 and L5; * Individuals capable of adequately adhering to the study protocol and responding to the administered questionnaires; * Signed informed consent. Exclusion Criteria: * Subjects with a history of major depression or other psychiatric conditions that, in the investigator's opinion, may interfere with study participation; * Patients in presumed/confirmed pregnancy; * Patients for whom the placement of spinal/ganglion stimulation systems is contraindicated due to systemic pathological conditions.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Analgesic efficacy identifying the pathogenetic cluster with the greatest therapeutic response

Timeframe: at 6 months

Trial details

NCT IDNCT06225960

SponsorIstituti Clinici Scientifici Maugeri SpA

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-02-19

View on ClinicalTrials.gov More Postherpetic Neuralgia trials