PRACTICAL study V1.0
Research type
Research Study
Full title
A Prospective Trial to Assess Evoked Electrical Activity above and below Spinal Cord Injury Lesions using the EVOKE™ Spinal Cord Stimulator.
IRAS ID
320715
Contact name
Anu Kansal
Contact email
Sponsor organisation
South Tees Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Patients with spinal cord injuries (SCI) and neuropathic pain below or at the level of the injury will be recruited to the study. We aim to implant into 10 patients with SCI from the study centre. Patients will have two leads inserted into their spine and this will be tested to see if they have reduction in pain over 7-10 days. If this is successful, then they will have the battery device implanted under their skin around their abdomen or buttock. If unsuccessful, these leads will be removed. Patients with the full implant will be followed up at one month, three months and six months. The main outcome of interest is a reduction in pain, but we will also measure changes in nerve function, spasticity, disability, health status and quality of life. The device can measure nerve activity above and below the level of the injury, this will be used to measure nerve responses to the electrical stimulation of the device as well as nerve responses to physical stimulation of the participant (eg of the legs) below the injury.
REC name
HSC REC B
REC reference
23/NI/0153
Date of REC Opinion
11 Dec 2023
REC opinion
Further Information Favourable Opinion