Research with human participants

Overview of medical research in the Netherlands

Dorsal root ganglion stimulation and motor responses in patients, who have been implanted with a dorsal root ganglion stimulation device: a pilot study

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The aim of this pilot study is to investigate if DRG stimulation can evoke motor reactions in the lower extremities in patients who have already been implanted with a DRG stimulator to treat neuropathic pain.

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Spinal cord and nerve root disorders
Study type
Observational non invasive

ID

NL-OMON43596

Source

ToetsingOnline

Brief title

DRG study

Condition

  • Spinal cord and nerve root disorders

Synonym

Motor reponse

Research involving

Human

Sponsors and support

Primary sponsor :
Erasmus MC, Universitair Medisch Centrum Rotterdam
Source(s) of monetary or material Support :
Ministerie van OC&W

Intervention

Keyword :
Dorsal root ganglion stimulation, Motor responses, Pilot study

Outcome measures

Primary outcome

The main study parameter is to evoke motor reactions in the lower extremities

in patients who have already been implanted with a DRG stimulator to treat

neuropathic pain.

Secondary outcome

Not applicable.

Background summary

Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion (DRG) stimulation are
well established treatment modalities to manage pain control. In 2014 Angeli et
al demonstrated that neuromodulation can also be used to facilitate standing
and stepping in patients with a complete motor Spinal Cord Injury (SCI). We
want to investigate if a DRG stimulator can evoke motor reactions in the lower
extremities in patients who have already been implanted with a DRG stimulator
to treat neuropathic pain. If we can evoke motor reactions in the lower
extremities in these patients, we will start a follow up study.

Study objective

The aim of this pilot study is to investigate if DRG stimulation can evoke
motor reactions in the lower extremities in patients who have already been
implanted with a DRG stimulator to treat neuropathic pain.

Study design

This is a prospective pilot study

Study burden and risks

The burden associated with participation is that they will have to undergo the
following test: EMG. This test doesn't hurt. There aren't risks associated with
participation.

Public
Erasmus MC, Universitair Medisch Centrum Rotterdam

's Gravendijkwal 230
Rotterdam 3000CA
NL
Scientific
Erasmus MC, Universitair Medisch Centrum Rotterdam

's Gravendijkwal 230
Rotterdam 3000CA
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Patients who are surgically implanted with a lumbar DRG stimulation device.

Exclusion criteria

Depression or an anxiety disorder
Pregnancy
Life expectancy < 1year

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
10
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL54623.078.15