Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT02823158
Eligibility Criteria:
Inclusion Criteria:
* Parkinson's disease according to the UKBB criteria, with the exception that familial forms of otherwise typical parkinsonian syndromes may also be included
* motor complications of dopaminergic medication (dyskinesia or motor fluctuations or both) that are at least moderately bothersome to the patient \[on a scale of 5 possible levels: not at all / mildly / moderately / severely / extremely bothersome\]
* Presence of at least one of the following absolute exclusion criteria for STN stimulation:
* Mattis dementia rating scale \<130 points
* postural instability of \>1 in the item of MDS-UPDRS III \[item #12\] "on" medication
* less than 30% improvement of axial score in the acute levodopa challenge test \[axial score =sum of items 3.1, 3.9, 3.10, 3.12, 3.13 of the MDS UPDRS III\]
* or presence of at least two of the following relative exclusion criteria for STN stimulation:
* age \> 70 years
* Mattis dementia rating scale \<134 points
* gait freezing "on" medication
* dysarthria of \> 2 in the item of the MDS-UPDRS III \[item #3.1\]
* less than 50% improvement of axial score in the acute levodopa challenge test \[axial score = sum of items 3.1, 3.9, 3.10, 3.12, 3.13 of the MDS UPDRS III\]
* Starkstein apathy score of ≥14
* Complete baseline PDQ-39-SI and patient diary available
* written informed consent
Exclusion Criteria:
* Age \> 85 years
* surgical or medical contraindications
* abnormalities on brain MRI that preclude the implantation of electrodes into the GPi
* contraindication for 3T MRI (baseline imaging)
* severe medical illness that is likely to hamper the benefit of DBS
* severe personality disorder that may interfere with optimization of DBS
* dementia according to DSM-V and MMSE \< 20
* ongoing psychosis (except pseudohallucinations)
* ongoing major depression (BDI-II \> 23) or depression of any severity with suicidal ideation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02823158
Study Brief:
Protocol Section:
NCT02823158