SCS biomarker study.
Research type
Research Study
Full title
Spinal Cord Stimulation for Neuropathic Pain: Biomarkers of Efficacy and Nerve Regeneration.
IRAS ID
242239
Contact name
Praveen Anand
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Spinal cord stimulation (SCS) has been an effective licensed treatment for chronic pain for decades. This involves implanting electrodes (wires) overlying the covering of the spinal cord, to deliver mild electrical impulses. However, there is still limited understanding of the underlying mechanisms, and there are few useful predictors of pain relief. Deeper understanding of pathophysiological changes is thus required, utilising recent advances in techniques for assessment of subjects. Further, there are no clinical interventions at present to enhance nerve regeneration. As pre-clinical studies suggest nerve stimulation may enhance nerve regeneration, this also requires assessment.The primary objective of this study is to further our understanding of the mechanisms involved in pain relief by SCS, and its potential for nerve regeneration. Subjects with chronic sciatica (nerve leg pain) will be recruited for this study, who have been planned to receive SCS as standard of care in their NHS Pain Clinic. They will be studied with our techniques, to assess their chronic neuropathic pain relief in relation to sensory tests, and nerve regeneration biomarkers in skin biopsies.There are different modalities of SCS, which may be equally effective, but some preferred by patients based on personal experience. While classical tonic SCS produces tingling when activated, recently High Frequency (HF) stimulation has also been used successfully, which can produce pain relief without the experience of paresthesia (tingling). Patients may respond variably to modes of SCS, which are licensed for clinical use, and often tried in turn routinely to see which mode is more effective and preferred by the subject. The different modes are delivered using the same spinal cord stimulator device which has been implanted. In this study, the classical routine tonic SCS will be tried first for 3 months, followed by another mode of stimulation for the next 3 months if the initial mode of treatment if satisfactory. The first 3 months’ treatment and assessments are the basis of the study, the next 3 months are optional and may provide useful pilot data.
Classical tonic SCS and High-frequency SCS modalities are both approved for treating refractory pain and are considered as the standard of care for many pain conditions. Decisions about SCS and the standard care of individual patients will be taken only by Consultants in Pain Medicine at the three Pain Clinics (which are the PICs). At the research site (Imperial College London) patients who have been identified by PICs as potential participants will be assessed with validated questionnaires, sensory tests and skin biopsy i.e. only aspects related to the research study, and not the SCS or standard of care
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
19/SW/0161
Date of REC Opinion
25 Sep 2019
REC opinion
Further Information Favourable Opinion