None listed
Conditions
Brief summary
This project aims to develop an improved understanding of how deep brain stimulation influences different motor symptoms of Parkinson’s disease. Specifically, it is anticipated that the outcomes of this research will clarify the effect of deep brain stimulation on symptoms relating to walking ability and balance, which will help to enhance the post-operative management of people with Parkinson’s disease following deep brain stimulation.
Interventions
30 Patients who have previously undergone bilateral deep brain stimulation surgery that has targeted the subthalamic nuclei (DBS-STN) and who agree to participate will be invited to complete two testing sessions conducted on non-consecutive days of no more than 2-weeks apart at the Asia-Pacific Centre for Neuromodulation in Brisbane. Patients will be asked to withdraw from any pharmacological treatments (i.e. treatment that is supplementary to DBS-STN) 12 hours prior to (i.e. overnight) each of
30 Patients who have previously undergone bilateral deep brain stimulation surgery that has targeted the subthalamic nuclei (DBS-STN) and who agree to participate will be invited to complete two testing sessions conducted on non-consecutive days of no more than 2-weeks apart at the Asia-Pacific Centre for Neuromodulation in Brisbane. Patients will be asked to withdraw from any pharmacological treatments (i.e. treatment that is supplementary to DBS-STN) 12 hours prior to (i.e. overnight) each of these sessions to negate the effects of these therapies and facilitate the exclusive evaluation of the DBS-STN therapy. The adherence to the withdraw will be confirmed via questionnaires on the day of testing. During each testing session, patients will be assessed under two therapeutic conditions, details of which are outlined below, and data collection for each condition is expected to take between 2 and 3 hours (including rest breaks). Specifically, the DBS-STN conditions to be examined will include: Day 1, Condition 1: DBS-STN electrodes bilaterally active (ON) with clinically-recommended settings. Clinically-recommended settings determined by usual programming procedures (e.g. =130Hz, 2-4 Volts, 60us). Day 1, Condition 2: DBS-STN electrodes bilaterally set to low frequency (60Hz) with an adjusted voltage to maintain the total electrical energy derived with clinically-recommended settings. Day 2, Condition 1: DBS-STN electrodes bilaterally active (ON) with clinically-recommended settings. Clinically-recommended settings determined by usual programming procedures (e.g. =130Hz, 2-4 Volts, 60us). Day 2, Condition 2: DBS-STN electrodes bilaterally inactive (OFF) The order of therapeutic conditions within each day will be assessed in a randomized order and all patients will be assessed under each condition. There will be a one-hour wash in period after change of stimulation before assessment takes place. The interventions (setting changes) will be performed by a registered nurse who specialises in the post-operative management of DBS-STN patients
Sponsors
Dr. Michael Cole
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Individuals clinically-diagnosed with idiopathic PD who have undergone DBS-STN no less than 12-months previous to the day of testing.
Exclusion criteria
Participants will be excluded if they; 1) have had recent surgery or have a history of recurrent musculoskeletal injury; 2) are unable to walk without assistance; or 3) have significant cognitive impairment (Standardized Mini Mental State Examination <25).
Outcome results
None listed