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. - LOC-PD: Part I, LOC-EARLY; Part II, LOC-DBS

niversitätsklinikum Tübingen, Abteilung Neurologie mit Schwerpunkt Neurodegenerative Erkrankungen0 sites400 target enrollmentJuly 9, 2020

ConditionsG20 Parkinson disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: G20
Sponsor: niversitätsklinikum Tübingen, Abteilung Neurologie mit Schwerpunkt Neurodegenerative Erkrankungen
Enrollment: 400
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 9, 2020

End Date

TBD

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

niversitätsklinikum Tübingen, Abteilung Neurologie mit Schwerpunkt Neurodegenerative Erkrankungen

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.