EvokeTM Data Collection
Research type
Research Study
Full title
Prospective data collection to evaluate the feedback control of the Saluda Medical’s EvokeTM Spinal Cord Stimulation System in the treatment of patients with chronic pain of the trunk and/or limbs: EvokeTM Data Collection
IRAS ID
263446
Contact name
Dave Mugan
Contact email
Sponsor organisation
Saluda Medical Europe Ltd
Clinicaltrials.gov Identifier
Not available yet, Planned to register the data collection in http://www.clinicaltrials.gov
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The EvokeTM SCS is a new type of SCS system, which can make some nerve recordings from the wires while they are in place close to your nerves. The system measures the electrical response from the nerves and uses these to
automatically alter the stimulation strength. By keeping the strength of the stimulation within a narrow range the patient no longer feels abrupt changes in stimulation and can move around without over or under stimulation.
All these data (recordings and alterations in stimulation) are automatically stored inside the device, and this is the
data we want to examine. The purpose of this data collection is to describe and evaluate the device data that are
stored automatically within the system and to determine if we can use these device data in combination with baseline and demographic data (Age, gender, type of pain) as prognostic indicators.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
19/YH/0253
Date of REC Opinion
5 Aug 2019
REC opinion
Favourable Opinion