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ID
Source
Brief title
Health condition
neuropathic pain
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 during resting-state MEG, under various stimulation settings and compared with control subjects.
Secondary outcome
Differences in connectivity within cortical pain processing areas, and between pain processing areas and attention areas during resting-state MEG, under various stimulation settings and compared with control subjects.
Modulation of evoked responses to peripherally applied electrical stimulation, under various stimulation settings and compared with control subjects.
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. In this explorative prospective controlled study in patients who already have a spinal cord stimulator and matched control subjects with and without chronic pain, we image with magneto-encephalography (MEG) the supraspinal effects of several SCS settings
Study objective
Pathological neural oscillations identified with MEG source imaging will be normalized when tonic and/or burst SCS causes pain reduction
Study design
Patients with SCS will have MEG sessions with three different stimualtion settings, eacht with one week in between. Control subjects will have one MEG session.
Inclusion criteria
• Over 18 years,
• SCS for at least 3 months,
• Stable response to 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
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
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8345 |
| CCMO | NL63267.091.17 |
| OMON | NL-OMON46671 |