Pathway CH S&E Registry
Research type
Research Study
Full title
Pathway CH S&E Registry. Data collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache
IRAS ID
180973
Contact name
David Barnes
Contact email
Sponsor organisation
Autonomic Technologies Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Sphenopalatine Ganglion Stimulation (SPGS) is a new treatment that can be used to treat severe Cluster Headache. The treatment ustilises a micro-stimulator that is inserted via a small oral procedure. The micro-stimulator is positioned so that it is able to provide small amounts of energy to a part of the nervous system know as the Sphenopalatine Ganglion (SPG). This small bundle of nerves sits directly behind the nose and has been shown to be involved in the development of cluster headaches. Once inserted, the micro-stimulator can be activated via a mobile phone like device and will deliver painless energy to the SPG thereby stopping the headache. The micro-stimulator has previously been evaluated in a randomized controlled study and shown to be of significant benefit to cluster headache sufferers. There are now more than 200 micro-stimulators implanted across Europe, but none yet in the UK.
The primary objectives of the Registry we would like to run at the Walton Center are:
1. Monitor the transfer of the ATI Neurostimulation System and its safety/clinical performance from a small number of study centers to a larger number of centers in the post market phase.
2. Collect additional evidence to support reimbursement and clinical acceptance during long term follow up (five years).REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0914
Date of REC Opinion
15 Dec 2015
REC opinion
Favourable Opinion