Image with magneto-encephalography (MEG) the supraspinal effects of conventional and burst SCS settings in patients who already have a spinal cord stimulator, to study the analgesic mechanisms of action of SCS and to improve the treatment of chronic…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in the power in frequency bands in cortical pain processing areas
as well as attention areas under the three stimulation settings. Differences in
coherence and frequency coupling within pain processing areas, and between pain
processing areas and attention areas. Modulation of evoked responses to
peripherally applied electrical stimulation.
Secondary outcome
.
Background summary
Spinal Cord Stimulation (SCS) is an invasive last-resort pain treatment and
consists of electrical stimulation of the spinal cord dorsal column using an
implanted electrode and pulse generator. Despite its efficacy, SCS has limited
or no effect in approximately 35% of patients. Attempts to reliably predict
treatment success have failed, probably due to our limited understanding of its
mechanisms of action.
Study objective
Image with magneto-encephalography (MEG) the supraspinal effects of
conventional and burst SCS settings in patients who already have a spinal cord
stimulator, to study the analgesic mechanisms of action of SCS and to improve
the treatment of chronic pain.
Study design
A explorative prospective placebo controlled imaging study in patients who
already have a spinal cord stimulator and matched control subjects with and
without chronic pain.
Intervention
In a double-blind randomized design, patients will receive conventional tonic
SCS, burst SCS and placebo SCS, each for a one-week period. Four MEG sessions
will be performed at baseline and with tonic, placebo and burst SCS. Patients
are asked to keep pain-diaries throughout the study period. In addition, 5 age
and gender matched control subjects with chronic neuropathic pain (who are
preferably on the waiting list for having a SCS implant) will have up to two
MEG sessions and 5 age and gender matched control subjects without pain, will
have one MEG session to acquire control data.
Study burden and risks
Participating patients already have a stimulator implanted and will evaluate 3x
one week with different standard available stimulation settings. They are
programmed for one week with placebo stimulation which will probably increase
their pain during those weeks. They are also programmed with burst stimulation
for one week. According to previous studies, there is a good chance that burst
stimulation will cause a further reduction of their pain compared with tonic
SCS. There are no health risks associated with the study, nor are there any
harmful aspects with respect to participating. If patients benefit from burst
stimulation, permanently changing to this mode could be offered at the end of
the study. Participating patients should come to the institute to have a MEG
scan four times during the study period. There are no risks associated with MEG
imaging. Control subjects without pain will have one MEG recording session and
control subjects with chronic pain will have up to two MEG recording sessions.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
a patient with SCS must meet the following criteria:
* Over 18 years,
* SCS for at least 3 months,
* Stable response to conventional (tonic) stimulation,
* Pulse generator suitable for burst stimulation,
* Active tip of the implanted electrode at spinal level Th8 or below,
* Pulse generator implanted in the lower body,
* Capable of participation: travelling to the institute and filling in the questionnaires;a control subject with pain must meet the following criteria:
* Over 18 years,
* Chronic neuropathic pain in the lower body part,
* Preferably on a waiting list for a SCS implant,
* Capable of participation: travelling to the institute and filling in the questionnaires.;a control subject without pain must meet the following criteria:
* Over 18 years,
* No pain or other neurological disease,
* Capable of participation: travelling to the institute and filling in the questionnaires.
Exclusion criteria
* Severe pain that is interfering with the pain that the SCS is used for,
* Hospitalised or another form of serious decline of general health.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63267.091.17 |
| Other | studie wordt aangemeld zodra goedgekeurd |
| OMON | NL-OMON26558 |