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Trial record 18 of 20 for:    Recruiting, Not yet recruiting, Available Studies | Pain | Neurostimulation

Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy: (NSI-TD-002)

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ClinicalTrials.gov Identifier: NCT02435004
Recruitment Status : Recruiting
First Posted : May 6, 2015
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Dr med. Paolo Maino Viceprimario Anestesiologia, Ospedale Regionale di Lugano

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).

Condition or disease Intervention/treatment Phase
Neuropathy Small Fibre Device: Spinal Modulation Axium™ Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study Protocol Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy
Study Start Date : April 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Spinal Modulation Axium™
Spinal Modulation Axium™: an external trial neurostimulator (TNS) is used for the trial period, followed by an implanted neurostimulator (INS) if the TNS is successful. The TNS and INS are a pacemaker-sized devices that send out mild electrical pulses. The stimulator contains a battery and electrical components. Both TNS and INS are constant voltage devices. The TNS is used first and is worn on the outside of the clothing. The INS is implanted under the skin and support:
Device: Spinal 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.





Primary Outcome Measures :
  1. Change in pain intensity assessed by Numeric Rating Scale. [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435004


Contacts
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Contact: Paolo Maino, MD 0041918119590 paolo.maino@eoc.ch
Contact: Eva Koetsier, MD 0041918119590 eva.koetsier@eoc.ch

Locations
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Switzerland
EOC Lugano Recruiting
Lugano, Ticino, Switzerland, 6962
Contact: Paolo Maino, MD    0041918117590    paolo.maino@eoc.ch   
Contact: Eva Koetsier, MD    0041918117590    eva.koetsier@eoc.ch   
Sponsors and Collaborators
Dr med. Paolo Maino Viceprimario Anestesiologia

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Responsible Party: Dr med. Paolo Maino Viceprimario Anestesiologia, Viceprimario Anestesiologia, Ospedale Regionale di Lugano
ClinicalTrials.gov Identifier: NCT02435004     History of Changes
Other Study ID Numbers: NSI-TD-002
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Small Fiber Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases