Clinical Response of Impulsivity after DBS in Parkinson's Disease 1.0
Research type
Research Study
Full title
Which factors are important in predicting changes in Impulse Control Behaviours (ICBs) following Deep Brain Stimulation (DBS) for Parkinson’s disease?
IRAS ID
285162
Contact name
David Okai
Contact email
Sponsor organisation
South London and Maudsley NHS Foundation Trust
Clinicaltrials.gov Identifier
NCT04811807, Clinicaltrials.org; 285162, IRAS ID
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Impulse control behaviours (ICBs) are common in Parkinson’s disease (PD) and affect 20-40% of patients. It remains unclear if deep brain stimulation DBS for severe PD motor symptoms worsens or improves ICBs.
We wish to answer the following clinically important questions:
1) What is the risk of developing postoperative de novo ICBs after subthalamic nucleus STN DBS?
2) In those with a pre-existing history of ICBs, what is the likelihood of improvement or deterioration post-operatively?
3) Which factors are important in predicting changes in ICBs after STN DBS?
Answers to these questions will inform decisions as to whether DBS should proceed in certain groups of patients who might be considered vulnerable to the development of PD-ICBs. The results of this study will also guide clinicians when counselling PD patients, with and without impulsivity, before DBS.
Patients who are candidates for undergoing deep brain stimulation for their motor symptoms (as their routine care) will be invited to participate. This observational study will take ~ 13 months/subject starting from enrolment until 12 months after the operation. Multiple deep brain stimulation clinics across the UK will participate in this observational study. Patients will be assessed before and after the operation 4 times. We intend to access clinical data, and to further investigate ICBs, validated quantitative scales will be added which allows us to examine small, subtle changes in ICB, and importantly we will be able to identify risk factors/predictors and to assess the impact of ICBs on quality of life and on caregiver burden. These scales include self-administered (mail) and clinician-rated (over the phone). Orion MedTech has data-sharing agreements in place with all study sites as part of the DBS registry which cover the submission and storage of patient demographics, and a study-specific data transfer agreement will also be put in place to cover the bespoke study dataset which is not part of the DBS registry. Orion will grant access to study data to the research team who will be able to download this via encrypted connection for further analysis.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
21/LO/0580
Date of REC Opinion
11 Oct 2021
REC opinion
Further Information Favourable Opinion