The primary objective of this study is to assess the feasibility of placing neurostimulator leads in the epidural space based on intraoperatively recorded ECAPS
ID
Source
Brief title
Condition
- Other condition
- Spinal cord and nerve root disorders
Synonym
Health condition
Treatment for chronic pain
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter, successful ECAP guided lead placement, will be
determined at the end of phase 1, 2 (if applicable) and 3 (if applicable). The
study will be considered a success if phase 3 is completed and passes the test
for phase three.
Secondary outcome
The following parameters will be measured as secondary study parameters:
1. Neurophysiological characterisations
Recorded ECAP signals will be analysed after the procedure in the OR to
describe their morphology and propagation characteristics - these parameters
describe the type and physiology of the nerves activated by the epidural leads
and nerve root stimulus
2. Patient reported outcomes (collected at baseline, 3-, 6- and 12-months
follow-up). These will be collected via an online set of questionnaires
including:
• Health related quality of life (EQ-5D-5L)
• Brief Pain Inventory (BPI)
• Pain Detect
• Oswestry Disability Index (ODI)
• Hospital Anxiety and Depression Scale 2.1 (HADS)
• Patient Global Impression of Change (PGIC)
3,4,5 and 7: Device data concerning programming parameters after initial
programming and at follow-ups (contacts used, pulse width, stimulation
frequency and amplitude etc.) will be collected to assess: if the best
candidate electrodes identified in the operating room are used post operatively
(3). This same device data will be used to assess; if and how initial programs
change over time (4), to describe the programming parameters used (5), if ECAPs
can still be recorded at long-term follow up visits, and if there are any
detectable neurophysiological changes over time (7).
6. Procedural times will be captured on paper/electronic forms and programming
time will be derived from the device data captured on the Clinical Interface
Background summary
The positioning of Spinal Cord Stimulation (SCS) leads in the epidural space to
deliver therapy for chronic pain currently relies on intra-operative feedback
from the patient during the procedure. This feedback is not always very
reliable due to sedation, discomfort and peculiar positioning (prone) of the
patient on the operating table. By utilising the recording capabilities of a
new type of SCS system it may be possible to use objective neurophysiological
signals to optimally place leads. This could potentially improve the speed and
accuracy of the operation to implant the epidural leads and make the procedure
more comfortable for the patient.
Study objective
The primary objective of this study is to assess the feasibility of placing
neurostimulator leads in the epidural space based on intraoperatively recorded
ECAPS
Study design
This is a single-centre, open label, interventional, prospective feasibility
study with three distinct phases including an interim analysis of results
following each phase
Intervention
During the operative procedure standard Radio Frequency (RF) needles will be
used to transiently stimulate the nerve roots believed to carry sensory nerve
fibres that innervate the patients painful area. This will be done as well as
(phase 1 and 2) or instead of (phase 3) normal stimulation sensation mapping
through the epidurally implanted SCS leads.
Study burden and risks
Burden: The operative procedure may be a little longer than usual (20 minutes)
which may lead to increased discomfort for the patient.
Potential risks: There is an increased risk (in phase 3) of a second operative
procedure to reposition the lead if the ECAP based placements appears to be
sub-optimal. This may lead to an extended trial period with a slight increase
in the risk of infection.
There are no other expected risks aside of the known risks for neuromodulation
treatment.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
1. Subject has been included for implantation according to standard criteria
from the Dutch Neuromodulation Society
2. Chronic refractory pain as a result of post-laminectomy syndrome (FBSS) for
at least 6 months
3. Subject is 18 years or older
4. Subject is able and willing to comply with the protocol and follow-up
5. Subject is fluent in the Dutch language
6. Subject is able to provide written informed consent
Exclusion criteria
1. Subject is under 18 years old
2. Subject is pregnant or nursing
3. Subject is unable to operate the EvokeTM SCS System
4. Subject is an unsuitable candidate for SCS
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 EC goedkeuring wordt het onderzoek in het Nederlands trial register geregistreerd, voordat de eerste patient wordt geincludeerd. |
| CCMO | NL69419.100.19 |