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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT02435004
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02435004
Study Brief:
Protocol Section:
NCT02435004