ECAP
Research type
Research Study
Full title
EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients
IRAS ID
322831
Contact name
Serge Nikolic
Contact email
Sponsor organisation
Barts Health NHS Trust
Clinicaltrials.gov Identifier
154732, EDGE
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Spinal cord stimulation (SCS) is an approved treatment for people who suffer from significant spinal pain and or limb pain. It can be safely considered in people who have failed to improve with conventional treatment (rehabilitation, painkillers, spinal injections) and in people who do not require spinal surgery or people who have had spinal surgery but did not result in a significant improvement in pain and quality of life.
Spinal cord stimulation delivers electromagnetic pulses via a SCS electrode positioned in the epidural space, in a safe, controlled manner at the specific area of the spine associated with the area of one’s pain. The SCS procedure can be performed either under the general anaesthetic or deep intravenous sedation.
Historically, SCS and the optimal electrode placement was done under the intravenous sedation as it required an intraoperative “mapping”. This process necessitated a intraoperative reduction in the sedation dose so a patient would become less sleepy and more responsive and able to communicate with the operator and confirm the sensation of tingling in the body area affected by pain. This tingling sensation resulted from the spinal activation in response to the delivery of electromagnetic pulses.
This new SCS system can continuously record the activation of the spine resulting from the delivery of electromagnetic pulses. This system continuously adjusts the electromagnetic pulse output in response to the patient’s spinal activation, ensuring that the optimal treatment is being delivered.
This unique feature and the on-table analysis of the spinal neural activation is sufficient to ensure a good lead placement without the need for intraoperative mapping. Therefore, a patient can safely undergo a general anaesthesia instead of intravenous sedation.
This optimal lead placement and the new feature of adjusting the spinal cord stimulation output in response to an individual spinal activity, is likely to lead to better immediate and long-term outcomes (improvement in pain, function and quality of life).REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
23/YH/0138
Date of REC Opinion
14 Aug 2023
REC opinion
Further Information Favourable Opinion