To evaluate and quantify the various clinical effects of closed-loop SCS versus open-loop SCS on the underlying pathophysiological effects in CRPS.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the change in pain intensity at the end of the
study compared with baseline.
Secondary outcome
Changes between the end of the study and baseline on all other parameters will
be assessed and reported as secondary endpoints for this study.
Background summary
Conventional open-loop neurostimulation can offer relief for several
intractable pain conditions including complex regional pain syndrome (CRPS).
Spinal Cord Stimulation (SCS) is a thoroughly tested and well-described
neurostimulation technology.
Recently developed innovative closed-loop SCS controls stimulation dose by
measuring the recruitment of fibres in the dorsal column and by using the
amplitude of the evoked compound action potentials (ECAPs) to maintain
stimulation within an individualized therapeutic range.
CRPS is a complication after surgery or trauma. One or combinations of several
pathophysiological mechanisms can play a role: inflammation, sensory processing
disturbances, vasomotor, sudomotor and motor disturbances. This results in
different phenotypes of CRPS. The effect of conventional open-loop SCS in CRPS
can be related to a direct influence of SCS on at least a subset of its
underlying pathophysiological mechanisms. The additional benefits of
closed-loop SCS on the various pathophysiological mechanisms in CRPS are still
to be studied
Study objective
To evaluate and quantify the various clinical effects of closed-loop SCS versus
open-loop SCS on the underlying pathophysiological effects in CRPS.
Study design
Single-centre, explorative, prospective, open-label, single-blind, internally
controlled study.
Intervention
Patients will receive standard care and will have all the standard follow-up
visits and two additional visits. At every visit standard data is collected.
However, at baseline and each follow-up visit patients will get one or more
additional measurements to acquire quantitative data on various clinical
effects that the SCS can have on the underlying mechanisms of CRPS.
In addition, there will be a one-month period in the follow-up period during
which the stimulation will be switched to open-loop and a one-month period with
closed-loop for every participant, to allow for an internal control of the
stimulation effects.
Study burden and risks
Burden - Patients participating in the study will be subjected to some
additional burden, namely:
Two additional hospital visits will be required as compared to standard of care
treatment.
Patients will need to spend approximately 1hr longer than normal at the
hospital to complete baseline assessments, 45min longer than normal to complete
assessments at follow up visits prior to the 3-month visit and 1hr longer than
normal to complete assessments during 3-6-months follow up.
Risks - Additional risks to patients are minimal. Additional risks are
associated with the blood test and travel to/from the hospital for additional
visits
Benefit - There may be no direct benefit to patients participating in the
protocol but knowledge gained may benefit similar patients in the future.
Group relatedness - SCS is an established treatment option for refractory pain
associated with CRPS, we anticipate that this study will act as further
confirmation for this. We also foresee that the secondary investigations on
effect of SCS on particular CRPS phenotypes will better inform decision making
on the use of SCS in these particular presentations.
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
a subject must meet the standard Dutch Neuromodulation Society consensus
criteria for spinal cord stimulation and the following study criteria:,
- Over 18 year old
- Diagnosed with retractable unilateral, upper- or lower limp CRPS,
- Capable and willing to participate in the additional measurements.
Exclusion criteria
- Pain of other aetiology in addition to CRPS,
- Previously failed neuromodulation treatment (SCS or DRG).
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| Other | na goedkeuring door de METC wordt de studiein een trial register aangemeld |
| CCMO | NL74145.078.20 |