UnknownNot Applicable

Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy:

Switzerland31 participantsStarted 2015-04

Plain-language summary

A prospective, single-arm, mono-centre pilot study to obtain preliminary information on the ability of Dorsal Root Ganglion Stimulation (DRGS) in alleviating the painful symptoms in patients with small fiber neuropathy (SFN).

Who can participate

Age range

18 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: * 18 years or older at inclusion * Chronic, intractable painful SFN in the peripheral limbs during at least 12 months and a biopsy positive for SFN, with a chronic pain intensity of ≥ 6 on a Numeric Rating Scale (ranging from 0 to 10), for which previous drug therapy was unsuccessful * Stable medication dosage in the 30 days prior to inclusion * Stable pattern of neurological symptoms Exclusion Criteria: * Known or suspected non-compliance * Drug or alcohol abuse * Pain predominantly in upper limbs * Neuropathy or chronic pain in limbs of other origin than SFN * Peripheral vascular disease * Severe foraminal stenosis at the expected target level * Coagulation disorders * Known immune-deficiency * Other significant concomitant diseases and any concomitant malignancies * Presence of other indwelling devices

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

Change in pain intensity assessed by Numeric Rating Scale.

Timeframe: Pain intensity assessment during 2 weeks after inmplatation, at Time point 6 and 12 months after implantation.

Trial details

NCT IDNCT02435004

SponsorOspedale Regionale di Lugano

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04

Contact for this trial

Eva Koetsier, MD PhD LLM

0041918119590 eva.koetsier@eoc.ch

View on ClinicalTrials.gov More Neuropathy Small Fibre trials

Who can participate

Age range

18 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.