The primary objective of this clinical investigation is to demonstrate that the qualification rate with anatomic lead placement is non-inferior to the qualification rate with targeted lead placement (tonic paresthesia guided) for the BurstDRTM trial…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chronische hardnekkige pijn in romp en/of ledematen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the qualification rate for permanent system implant at
the end of the initial trial evaluation period
Qualification for permanent system implant is defined by a composite in which a
subject meets all of the following conditions:
* >50% patient reported pain relief (PRP) at the end of the trial evaluation
* The trial evaluation period lasted for a minimum of 3 days
* Physician recommends subject for permanent system implant
* Subject reports a willingness to pursue a permanent system implant
Subjects are not qualified for permanent system implant if they meet both of
the following:
* *50% PRP (patient reported pain relief) at the end of the trial evaluation
* Trial evaluation period lasted for a minimum of 5 days
Secondary outcome
The secondary endpoint is the rate of physician preference for anatomic
placement versus targeted placement at the end of the study.
Background summary
Spinal cord stimulation (SCS) is a common therapy for the treatment of chronic,
intractable pain.Typically, patients who are candidates for spinal cord
stimulation have failed other treatment options and are recommended by their
physician to participate in a spinal cord stimulation trial (powered by an
external generator) prior to receiving a permanent implant (powered by an
implantable pulse generator).This is done so that the patient can determine
whether the therapy relieves pain before undergoing a procedure to implant a
permanent device.
The trial consists of implanting trial electrode(s) or lead(s) into the
epidural space. The lead(s) may then be connected to an external generator,
allowing a trial period of stimulation.Current trial systems use external
generators in which the lead(s) are connected to via additional extension wires
that are tapped to the patient*s back.
St. Jude MedicalTM Invisible Trial System is using an External Pulse Generator
(EPG) and Patient Controller that communicates wirelessly with each other
eliminating the need for connector wires. The EPG is significantly smaller than
other systems available on the market and may be bandaged to the patient*s back
in the place of connector wires.
St. Jude MedicalTM Invisible Trial System enables the use of both tonic
stimulation and Burst stimulation. With tonic stimulation, the pulse is
delivered at the same amplitude, frequency and pulse width and typically
produces stimualtion sensation over the patient*s area of pain.During Burst
stimulation groups of pulses called bursts trains are repeated at a burst rate;
within each burst train, several pulses are issued at an intra-burst rate.
Individual pulses are characterized by a pulse amplitude and pulse width in
exactly the same manner as in tonic stimulation. The amplitudes used for Burst
stimulation are reported to be significantly lower than those traditionally
used for tonic stimulation which results in stimulation sensation free therapy
with continued pain suppression.
Lead placement can be done using two different techniques; targeted lead
placement, in this case the patient is tonic stimulated during placement and
the patient can tell where the stimulation sensation is felt. this is where the
lead will be placed. The second technique is anatomic lead placement. In this
case the lead is placed between vertbrae Th7 and Th10 without any testing or
stimulation.
Study objective
The primary objective of this clinical investigation is to demonstrate that the
qualification rate with anatomic lead placement is non-inferior to the
qualification rate with targeted lead placement (tonic paresthesia guided) for
the BurstDRTM trial evaluation period.
Study design
A randomized, controlled, single blinded, multi-centered study
Intervention
SCS trial stimulation
Study burden and risks
The risks of participating in the study are virtually the same as the risks of
a normal trial stimulation period for the treatment of chronic pain. In this
study different methods for leadplacement are compared with each other, but
this does not increase the risk for the participant.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
1. Patient is indicated for SCS therapy in accordance with the approved labeling.
2. Patient*s pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage.
3. Patient has a baseline score on the NRS *6 over the past 24 hours for *average overall pain* specific to the area(s) of chronic pain that will be treated with spinal cord stimulation.
4. Patient is considered by the Study Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions for Use.
5. Patient is >18 years of age at the time of enrollment.
6. Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits.
7. Patient has signed and received a copy of the EC/IRB approved informed consent.
Exclusion criteria
1. Patient currently has a spinal cord stimulation system implanted.
2. Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant).
3. Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
4. Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure).
5. Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).
6. Patient is currently participating in another clinical investigation with an active treatment arm.
7. Patient is unable to read and/or write.
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 |
|---|---|
| CCMO | NL58717.091.16 |