Evaluating a pragmatic workflow for adaptive Deep Brain Stimulation
Research type
Research Study
Full title
A single centre, unblinded, naturalistic pilot study to evaluate the feasibility, safety and efficacy of implementing a pragmatic dual threshold adaptive Deep Brain Stimulation workflow intended for general clinical use.
IRAS ID
360626
Contact name
Alan Whone
Contact email
Sponsor organisation
North Bristol Trsut
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The research study is a single centre, unblinded, naturalistic pilot study to evaluate the feasibility, safety and efficacy of implementing a pragmatic dual threshold adaptive Deep Brain Stimulation (aDBS) workflow intended for general clinical use for the management of Parkinson’s disease. The objectives of the study are to determine the feasibility of implementing the pragmatic aDBS workflow and the tolerability and patient acceptance of such workflow. Participants who are diagnosed with Parkinson’s disease and are already implanted and receiving DBS treatment with Medtronic's Percept PC or RC neurostimulator with sensing leads, will be optimised on continuous DBS and subsequently switched to aDBS. The feasibility of the workflow will be assessed through the amount of training needed for the clinical staff to be able to implement the new treatment, the number of visits and programming time required for each patient to be optimised on aDBS, staff and patient satisfaction with the workflow, achievement of participant goals defined at the beginning of the study, improvements in symptom management and quality of life, and in-depth, semi-structured interviews with the participants, their carers and the clinical staff on their experiences with the new workflow and treatment. Furthermore, the participants will need to complete standard-of-care questionnaires and assessments to evaluate the effectiveness of the treatment, as well as a personal home diary to report on their symptoms. They will also be given a lumbar wearable to wear at the beginning and end of the study, specifically designed to monitor Parkinson’s disease symptoms to provide additional information on symptom management and treatment efficacy.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
26/SW/0022
Date of REC Opinion
31 Mar 2026
REC opinion
Further Information Favourable Opinion