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| Name | Class |
|---|---|
| HagaZiekenhuis | OTHER |
| Maastricht University Medical Center | OTHER |
| Universitair Ziekenhuis Leuven | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aDBS group | Experimental | 65 patients with Parkinson's disease will receive adaptive DBS. |
|
| cDBS group | Active Comparator | 65 patients with Parkinson's disease will receive continue DBS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive DBS | Other | The Medtronic Percept device will be activated with the aDBS functionality. Participant will receive adaptive DBS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Home PD diary | 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 | change from baseline to six months of DBS |
| Measure | Description | Time Frame |
|---|---|---|
| PD Home diary | ON time without troublesome dyskinesia | during six months of follow-up |
| PD Home diary | ON time with troublesome dyskinesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| M. Beudel, MD, PhD | Contact | +31 20 566 9111 | closepd@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Martijn Beudel, MD, PhD | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Not yet recruiting | Leuven | Belgium |
Upon request, IPD will be shared through restricted access via a secure online database.
It will be available two years after the results are published.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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double-blinded
| Continue DBS | Other | 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. |
|
| during six months of follow-up |
| PD Home diary | ON time without dyskinesia | during six months of follow-up |
| PD Home diary | OFF time | during six months of follow-up |
| PD Home diary | Asleep time | during six months of follow-up |
| MDS-UPDRS III (ON and OFF phase) | Motor symptoms | change from baseline to six months of DBS |
| MDS-UPDRS IV | Motor complication including motor fluctuations and dyskinesias | change from baseline to six months of DBS |
| Academic Medical Center Linear Disability Score (ALDS) (ON and OFF phase) | Level of physical disability | change from baseline to six months of DBS |
| Parkinson's Disease Questionnaire 39 (PDQ-39) | Quality of life | change from baseline to six months of DBS |
| Dopaminergic medication usage | during six months of follow-up |
| Montreal Cognitive Assessment (MoCA) | MoCA is a cognitive screening tool for detecting and scoring cognitive impairment | change from baseline to six months of DBS |
| Beck Depression Inventory (BDI) | Mood status | change from baseline to six months of DBS |
| Starkstein Apathy Scale (SAS) | Apathy status | change from baseline to six months of DBS |
| Parkinson's Disease Sleep Scale (PDSS-2) | Sleep disturbances and quality of sleep | during six months of follow-up |
| Side effects | Number and sort of side effects | during six months of follow-up |
| Time of DBS titration | Duration of DBS titration based on the number and duration of hospital visits | during six months of follow-up |
| Time to final adjustment of the DBS settings | first time point for stimulation parameters following the last adjustment of the stimulation parameters | during six months of follow-up |
| Assessor's evaluation of the ease of programming | Five-point Likert scale | after six months of follow-up |
| Beta oscillatory activity | Amount of decrease of oscillatory activity in the beta range | during six months of follow-up |
| DBS settings (1) | Electrical energy consumption expressed by the Total electrical energy delivered (TEED) | during six months of follow-up |
| DBS settings (2) | DBS amplitudes in mA | during six months of follow-up |
| DBS settings (3) | Average stimulation fraction expressed as percentages | during six months of follow-up |
| LFP characteristics (2) | Beta power spectral density expressed as µV²/Hz | during six months of follow-up |
| LFP characteristics (2) | Beta volatility expressed as a.u. | during six months of follow-up |
| Participant's evaluation of the burden of the treatment | Five-point Likert scale | after six months of follow-up |
| Participant's satisfaction on the outcome of treatment | Five-point Likert scale | after six months of follow-up |
| Amsterdam UMC | Recruiting | Amsterdam | Netherlands |
|
| Maastricht UMC+ | Not yet recruiting | Maastricht | Netherlands |
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| HagaZiekenhuis | Not yet recruiting | The Hague | Netherlands |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |