Deep Brain Stimulation, Parkinson Disease
Conditions
Keywords
adaptive DBS, continue DBS, aDBS, cDBS
Brief summary
The objective of the CLOSE-PD study is to compare the efficacy of adaptive deep brain stimulation (aDBS) with continue deep brain stimulation (cDBS) in patients with Parkinson's disease. The main question it aims to answer is: \- whether the change in daily mean ON time without troublesome dyskinesia in aDBS is greater than cDBS over a six-month follow-up period? Researchers will compare aDBS to regular continue deep brain stimulation (cDBS). Participants will: * be set up to cDBS during the first programming visit (visit 2); * be randomized 1:1 to aDBS or cDBS two weeks after visit 2; * follow-up will be at three and six months after visit 2; * complete PD Home diary at baseline, two weeks, three months and at six months after visit 2.
Interventions
OTHERAdaptive DBS
The Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS.
OTHERContinue DBS
The Medtronic Percept device will be equipped with aDBS functionality (to maintain the blinding of the allocation), but this functionality will remain inactive. Participant will receive continue DBS.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
HagaZiekenhuis
Maastricht University Medical Center
Universitair Ziekenhuis Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
double-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of idiopathic PD based on the UK Brain Bank criteria (Hughes et al. 1992); * Age older than 18 years; * Previous implantation of Medtronic PerceptTM PC/RC DBS electrodes bilateral targeting the STN; * Optimal contact point compatible with aDBS in at least one STN; * Reliable beta peak in at least one STN; * Able to provide informed consent and comply with the study protocol; * Understand the Dutch language.
Exclusion criteria
* Legally incompetent adults; * Patients with ongoing participation in other clinical trials involving neurological interventions; * Inability to recognize the difference between the motor ON or OFF state; * Mild cognitive impairment or dementia; * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Home PD diary | change from baseline to six months of DBS | The primary outcome is the comparison between the aDBS group and the cDBS group of the change from baseline to six months in mean daily ON time without troublesome dyskinesia. Daily ON time without troublesome dyskinesia is measured with the PD home diary. The PD home diary is a self-reported tool for tracking motor symptoms in Parkinson's patients every 30 minutes for three days within a one-week window |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PD Home diary | during six months of follow-up | ON time without troublesome dyskinesia |
| MDS-UPDRS III (ON and OFF phase) | change from baseline to six months of DBS | Motor symptoms |
| MDS-UPDRS IV | change from baseline to six months of DBS | Motor complication including motor fluctuations and dyskinesias |
| Academic Medical Center Linear Disability Score (ALDS) (ON and OFF phase) | change from baseline to six months of DBS | Level of physical disability |
| Parkinson's Disease Questionnaire 39 (PDQ-39) | change from baseline to six months of DBS | Quality of life |
| Dopaminergic medication usage | during six months of follow-up | — |
| Montreal Cognitive Assessment (MoCA) | change from baseline to six months of DBS | MoCA is a cognitive screening tool for detecting and scoring cognitive impairment |
| Beck Depression Inventory (BDI) | change from baseline to six months of DBS | Mood status |
| Starkstein Apathy Scale (SAS) | change from baseline to six months of DBS | Apathy status |
| Parkinson's Disease Sleep Scale (PDSS-2) | during six months of follow-up | Sleep disturbances and quality of sleep |
| Side effects | during six months of follow-up | Number and sort of side effects |
| Time of DBS titration | during six months of follow-up | Duration of DBS titration based on the number and duration of hospital visits |
| Time to final adjustment of the DBS settings | during six months of follow-up | first time point for stimulation parameters following the last adjustment of the stimulation parameters |
| Assessor's evaluation of the ease of programming | after six months of follow-up | Five-point Likert scale |
| Beta oscillatory activity | during six months of follow-up | Amount of decrease of oscillatory activity in the beta range |
| DBS settings (1) | during six months of follow-up | Electrical energy consumption expressed by the Total electrical energy delivered (TEED) |
| DBS settings (2) | during six months of follow-up | DBS amplitudes in mA |
| DBS settings (3) | during six months of follow-up | Average stimulation fraction expressed as percentages |
| LFP characteristics (2) | during six months of follow-up | Beta power spectral density expressed as µV²/Hz |
| Participant's evaluation of the burden of the treatment | after six months of follow-up | Five-point Likert scale |
| Participant's satisfaction on the outcome of treatment | after six months of follow-up | Five-point Likert scale |
Countries
Belgium, Netherlands
Contacts
CONTACTM. Beudel, MD, PhD
PRINCIPAL_INVESTIGATORMartijn Beudel, MD, PhD
Amsterdam UMC
Outcome results
None listed