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Table 1 Eligibility criteria

From: Combined subthalamic and nucleus basalis of Meynert deep brain stimulation for Parkinson’s disease with dementia (DEMPARK-DBS): protocol of a randomized, sham-controlled trial

Inclusion criteria: Exclusion criteria:
1. Age at enrollment: 35–75 years.
2. Diagnosis of idiopathic PD with probable PDD, defined by MDS consensus guidelines [13].
3. Mild-to-moderately severe dementia, defined by MMSE score 10–24.
4. Duration of bilateral idiopathic PD: ≥5 years of motor symptoms.
5. Severity of bilateral idiopathic PD in medication-off state: modified Hoehn and Yahr stage ≥2.
6. Unified Parkinson’s Disease Rating Scale (UPDRS) III score ≥ 30 in medication-off/stimulation-off state.
7. Levodopa must improve PD symptoms by ≥30% in levodopa challenge test (UPDRS III score).
8. PDD with symptom onset at least 2 years after first symptoms of PD.
9. Willing and able to comply with all visits and study-related procedures (e.g., using the remote control and charging systems, completing the motor diary) if mentally competent or, if incompetent, their legally-authorized representatives.
10. Able to understand the study requirements and treatment procedures and provide written informed consent before any study-specific tests or procedures are performed. If mentally incompetent, the legally-authorized representative will provide written informed consent.
1. Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression.
2. Any current drug or alcohol abuse.
3. Any history of recurrent or unprovoked seizures.
4. Any prior movement disorder treatments involving intracranial surgery or device implantation.
5. History of neurostimulation intolerance in any area of the body.
6. Any significant medical condition likely to interfere with study procedures or confound evaluation of study endpoints, including any terminal illness with survival < 12 months.
7. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
8. Pregnancy, breastfeeding, or lack of reliable contraception.