Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02823158 : Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease-LATESTIM
PhaseN/A
AgesMin: 18 Years Max: 85 Years
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02823158      |      Link to official Clinicaltrials.gov listing
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