Neuropathy Small Fibre
Conditions
Brief 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).
Detailed description
This study is a prospective, single-arm, mono-centre pilot study enrolling a maximum of 31 patients with SFN. All enrolled patients will receive a trial neurostimulation (TNS) lasting from 3 to 30 days and only patients with a positive result in terms of pain intensity reduction will be eligible for the implanted neurostimulation (INS) phase. The target number of patients eligible for INS is 10 and this population will be assessed for impact of DRGS on the neuropathic pain caused by SFN. The expected duration of patients participation will be 14 months. The rationale for this open label approach is that this is a novel technique for which pilot data with regard to applicability and efficacy have yet to be established. Data gathered in the study will provide preliminary data required to assess the feasibility of this intervention, to be used for possible future studies with a more rigorous methodological approach (i.e. controlled trial, randomized controlled trial).
Interventions
DEVICESpinal Modulation Axium™
The participants will undergo implantation of electrodes for stimulation of fuor dorsal ganglia (Spinal Modulation, Inc., Menlo Park, CA, USA). Each participant will have one to four electrodes positioned according to the individual distribution of pain in the extremities. After implantation the electrode will be connected to an external neurostimulator: Spinal Modulation Axium™ for 3-30 days to evaluate their effectiveness (test stimulation). If during the trial treatment the pain will decrease significantly (\> 50%) a neurostimulator will be 'implanted for the continuation of the permanent neurostimulation. The neurostimulator is implanted in the abdomen in a subcutaneous pocket.
Sponsors
Ospedale Regionale di Lugano
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity assessed by Numeric Rating Scale. | Pain intensity assessment during 2 weeks after inmplatation, at Time point 6 and 12 months after implantation. | Four assessments/day for 5 consecutive days around the intended measurement timepoint |
Countries
Switzerland
Contacts
Primary ContactEva Koetsier, MD PhD LLM
Backup ContactPaolo Maino, MD PhD
Outcome results
None listed