CUSTOM-DBS
Research type
Research Study
Full title
Current Steering to Optimize Deep Brain Stimulation (CUSTOM-DBS)
IRAS ID
136806
Contact name
Alan Whone
Contact email
Sponsor organisation
Boston Scientific Europe
Clinicaltrials.gov Identifier
Research summary
Deep Brain Stimulation (DBS) has been shown to be an effective therapeutic tool for the alleviation of symptoms of Parkinson’s disease (PD). Patients with PD who have been implanted with the Vercise DBS system (made by Boston Scientific Corp.) for at least three months will be approached to participate in a study which seeks to investigate the effect of different stimulation settings on therapeutic efficacy and side effects.
Adjustment of the stimulator involves changing the amplitude of the stimulation, and also the pulse width. Studies have shown that a longer pulse width can shorten the ’therapeutic window’, that is the opportunity between the stimulation being therapeutic and the stimulation having too many side effects. The advantage of the Vercise system over other commercially available devices is that it may work during shorter pulse widths, which would therefore widen the ’therapeutic window’ and provide greater scope for improved stimulation. This study will therefore investigate whether a shorter pulse width is just as efficacious as longer pulse widths, and will compare the side effects experienced during these settings.
This study will look at 4 different stimulation settings in one test session on one day. Each patient who consents to participation and is eligible for participation will receive all 4 test settings, but the order of presentation will be randomised. The patients won’t know which order they will receive the test settings, and neither will the nurse who will be assessing the patient. A Clinical Field Engineer employed by Boston Scientific will be present at all assessments and will be the person changing the settings, and will therefore be the only person unblinded as to presentation order. Standard tests will be used by the nurse during each test setting to assess efficacy and tolerability.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
13/YH/0317
Date of REC Opinion
20 Dec 2013
REC opinion
Further Information Favourable Opinion