DRAGON
Research type
Research Study
Full title
TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion ensemble for refractory neuropathic pain: clinical efficacy and procedural efficiency a randomized, single centre study in participants diagnosed with neuropathic painy
IRAS ID
228782
Contact name
Adnan Al-Kaisy
Contact email
Sponsor organisation
Guy's and St Thomas Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 10 days
Research summary
This a single centre study comparing two forms of electrical stimulation: sub-sensory burst stimulation (DRG-Burst3D) and standard low frequency stimulation (DRG-LF) in the dorsal root ganglion of subjects diagnosed with neuropathic pain.
The dorsal root ganglion (DRG) is a bundle of nerves located within the spinal cord which acts to control pain sensations. Electrical stimulation of the DRG in subjects with neuropathic pain is an effective treatment to reduce pain which is used routinely in clinical care. Electrical stimulation is delivered in the dorsal root ganglion with the use of devices call spinal cord simulators which are implanted in the spinal cord.
The study will consist of two phases; a 26 day randomised trial phase in which the subject will assess the effectiveness of DRG-Burst3D and DRG-LF, and a 12 month post permanent implant follow up phase.
Eligible subjects will undergo a device trial for a maximum of 26 days, during the trial period subjects will receive both forms of electrical stimulation to try in a randomised manner; subjects who report a >=50% reduction in pain score will proceed to a permanent implant.
Post permanent implant subjects will receive both forms of electrical stimulation and will have option to use either in their preferred way. Subjects will be followed up at 1, 3, 6 and 12 months post permanent implant.Subjects will be assessed for pain, disability, quality of life, mental and physical function, patient global impression of change, subject satisfaction, work status, medication use, health care utilisation, and adverse events.
At all time-points, assessments and monitoring of pain and adverse events will be made.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
18/LO/0432
Date of REC Opinion
2 May 2018
REC opinion
Further Information Favourable Opinion