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 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT02894567
Eligibility Criteria:
Inclusion Criteria:
Patient foreseen to undergo DBS for Parkinson's disease or Essential Tremor according to routine criteria of the center.
For Parkinson Disease:
* Person is between 18 and 75 years of age
* Established diagnosis of idiopathic Parkinson's disease with progression of symptoms for a minimum of 2 years.
* Person has a history of at least 30% improvement on the UPDRS therapy in L-dopa (levodopa), except in the case of tremor dominant patient
* Weak control of symptoms by dopaminergic therapy (off phenomenon, fluctuations on / off, dyskinesia on)
For Essential Tremor:
* Person is between 18 and 80 years of age
* Established diagnosis of Essential Tremor for a minimum of 2 years
* Functional disability due to tremor was not adequately controlled by medication for at least 3 months prior to implant.
Person has given his/her written consent
Exclusion Criteria:
* Person suffering from an active major psychiatric disorder
* Mattis Dementia Rating Scale score \<130 or otherwise not capable of discernment
* Presence of major co-morbidity or medical condition that may affect participation to the study
* Presence of an electrical or electromagnetic implant (e.g., cochlear implant, pacemaker)
* Person with a previous surgery for the treatment of Parkinson's disease or Essential Tremor
* Person with a previous brain ablation procedure
* Person who suffers from epilepsy
* Person who is pregnant: a pregnancy test will be performed in patients of childbearing age
* Person with coagulopathies
* Abuse of drugs or alcohol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02894567
Study Brief:
Protocol Section:
NCT02894567