Prospective study to define clinical markers which predict 36 months outcome in the early disease phase (part I) and treatment response to deep brain stimulation (part II) in late stages of Parkinson’s disease.
- Conditions
- G20Parkinson disease
- Registration Number
- DRKS00017721
- Lead Sponsor
- niversitätsklinikum Tübingen, Abteilung Neurologie mit Schwerpunkt Neurodegenerative Erkrankungen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
Part I, LOC-EARLY: age = 18 years; PD diagnosis according to the MDS Task Force Criteria; disease duration = 3 years; ability to give consent and communicate well with the investigator, to understand and comply with the requirements of the study; written informed consent prior to undertaking any study-related procedures.
Part II LOC-DBS: Age between 18 and 80 years; eligible for DBS surgery according to best-practice strategies (DGN S3-Leitlinie Parkinson), response to levodopa > 30% verified by scores of the MDS-UPDRS-III assessed twice or medication-resistant disabling PD tremor; no signs of PDD; no neurosurgical contraindications; no relevant psychiatric (active depression, psychosis, suicidal ideation), or somatic competing disease; eligibility for DBS confirmed during an inpatient DBS screening procedure by an interdisciplinary board of neurologists, neurosurgeons, and psychiatrists; patients written informed consent for DBS surgery; ability to give consent and communicate well with the investigator, to understand and comply with the requirements of the study and good German language skills (primary or secondary language); having given written informed consent prior to undertaking any study-related procedures.
Part I, LOC-EARLY:
Under any administrative or legal supervision or unable to give informed consent; participation in any clinical investigation of a new investigational compound or therapy within 4 weeks prior to baseline visit, and for any other limitation of participation based on local regulations; patients with conditions/concomitant diseases making them non-evaluable for the defined outcomes (e.g. pre-existing neurological disease, brain disease other than PD, e.g. head trauma, stroke, encephalitis);
alcohol, medication, or drug dependency or abuse (except for nicotine); inability to meet specific protocol requirements (e.g., need for hospitalization, not able to read and understand the protocol); patient is directly involved in the conduct of the protocol: the investigator or a sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof; patient is uncooperative or has any condition that could make the patient potentially non-compliant to the study procedures; patients with presence of postural instability (MDS-UPDRS-III Item 3.12 = 1) at time of study inclusion;
- For the prediction of the dichotomous outcome referring to cognitive worsening:
Patients with diagnosis of dementia or cognitive impairment (MoCA=26) at time of study inclusion will not be included into the analysis
Part II, LOC-DBS:
Under any administrative or legal supervision or unable to give informed consent; participation in any clinical investigation of a new investigational compound or therapy within 4 weeks prior to baseline visit, and for any other limitation of participation based on local regulations;
diagnosis of dementia at time of study inclusion; surgical contraindication for implantation surgery; patients with conditions/concomitant diseases making them non-evaluable for the defined outcomes; alcohol, medication, or drug dependency or abuse (except for nicotine); inability to meet specific protocol requirements (e.g., need for hospitalization, not able to read and understand the protocol); patient is directly involved in the conduct of the protocol: the investigator or a sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof; patient is uncooperative or has any condition that could make the patient potentially non-compliant to the study procedures.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main objective in part I (LOC-EARLY) is to evaluate the predictive value of a single or a combination of markers (demographics, scale scores, environmental, imaging, biomarker data) commonly assessed within the clinical daily routine to predict each of three independent disease specific outcomes after 36 months in early PD. Presence of the following outcomes at months 36 is recorded:<br>Postural instability (Item 3.12 = 1, MDS-UPDRS-III) (primary outcome). <br><br>The primary objective in part II (LOC-DBS) is to evaluate the predictive value of a single or a combination of markers predicting a beneficial outcome of DBS surgeryaccording to the following criteria: Preserved or less reduced cognitive function at 36 months (MoCA score continuously scaled) (primary outcome).
- Secondary Outcome Measures
Name Time Method Part I, LOC-EARLY: Cognitive worsening: diagnosis of cognitive impairment (PD-MCI) or PDD according to Level I cognitive testing, (MoCA = 26) (secondary outcome); differential atypical PD diagnosis: appearance of red flags” indicating an atypical Parkinsonian syndrome (secondary outcome); diagnosis of atypical PD according to consensus guidelines (secondary outcome). <br><br>Part II, LOC-DBS: Improvement of MDS-UPDRS-III scores of at least 30% when comparing preoperative MDS-UPDRS-III scores without intake of dopaminergic medication (MedOff) and postoperative MDS-UPDRS-III scores in MedOff condition and with brain stimulator active (StimOn) at 36-month visit (secondary outcome).