Boston HF SCS PET Scan
Research type
Research Study
Full title
A prospective single blind pilot study to investigate the dynamic brain imaging response to changes in frequency parameters in patients with spinal cord stimulation with intractable neuropathic pain
IRAS ID
210812
Contact name
Vivek Mehta
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Spinal cord stimulation (SCS) is a therapy where electric pulses are delivered to the spinal cord by a small device implanted under the skin. Conventionally, patients receiving SCS are provided with tonic stimulation parameters, where the frequency of electrical pulses is set at 40-60Hz. The major side effect of tonic SCS parameters is the onset of paraesthesia, a tingling or pins and needles sensation within the target region, which can cause significant discomfort for some patients. However, newer methods include high-frequency stimulation (HF) which is able to provide paraesthesia free stimulation, ultimately providing better patient tolerability. HF stimulation is widely offered to patients with SCS as part of routine clinical practice. However, the effect on pathways in the brain remains to be characterised. This study therefore aims to investigate the clinical response to three frequency parameters 40Hz, 4000Hz and 10000Hz and also explore the brain imaging changes using PET-CT scans. We will also investigate the response to these stimulator settings on health related quality of life using validated questionnaires.
20 patients who are deemed suitable for SCS as part of NICE guidelines 159 pathway will be recruited for the study. All patients will have a baseline PET-CT scan and undergo first stage of SCS where they will be offered tonic 40Hz settings as part of trial stimulation. If successful (>50% improvement in pain scores) they will be offered second stage and continue to receive 40Hz stimulation for 4 weeks. After a second PET-CT scan patients are randomized to receive either 4000Hz or 10000Hz stimulation for 4 more weeks, then cross-over treatment for another 4 weeks. PET-CT scans will be performed between each level of stimulation and at the end of the study (4 in total).
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/0655
Date of REC Opinion
26 May 2017
REC opinion
Favourable Opinion