NCT02435004

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

7 years

First QC Date

April 15, 2015

Last Update Submit

March 24, 2021

Conditions

Neuropathy Small Fibre

Outcome Measures

Primary Outcomes (1)

  • Change in pain intensity assessed by Numeric Rating Scale.

    Four assessments/day for 5 consecutive days around the intended measurement timepoint

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

Study Arms (1)

Spinal Modulation Axium™

OTHER

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™

Interventions

Spinal Modulation Axium™DEVICE

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.

Spinal Modulation Axium™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 pattern of neurological symptoms

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EOC Lugano

Lugano, Canton Ticino, 6962, Switzerland

RECRUITING

Related Publications (1)

  • Koetsier E, Vacchi E, Maino P, Dukanac J, Melli G, van Kuijk SMJ. Dorsal Root Ganglion Stimulation in Chronic Painful Polyneuropathy: A Potential Modulator for Small Nerve Fiber Regeneration. Neuromodulation. 2023 Dec;26(8):1772-1780. doi: 10.1016/j.neurom.2022.08.455. Epub 2022 Oct 1.

    PMID: 36192280DERIVED

MeSH Terms

Conditions

Small Fiber Neuropathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Eva Koetsier, MD PhD LLM

CONTACT

0041918119590eva.koetsier@eoc.ch

Paolo Maino, MD PhD

CONTACT

0041918119590paolo.maino@eoc.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD LLM

Study Record Dates

First Submitted

April 15, 2015

First Posted

May 6, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2022

Study Completion

April 1, 2023

Last Updated

March 26, 2021

Record last verified: 2021-03

Locations

CH(1)