Essential Tremor, Parkinson's Disease
Conditions
Brief summary
The purpose of this study is to provide proof-of-concept that directional stimulation, in an intraoperative setting, is perceivable in a subject and is different from omnidirectional stimulation. The tests will be performed using a dedicated DBS lead connected to external neurostimulator.
Interventions
DEVICEdirectSTN Acute lead connected to external neurostimulator
Test phase will be performed intra-operatively, prior to chronic lead implant
Sponsors
Aleva Neurotherapeutics SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject is indicated to undergo DBS for Parkinson's disease or Essential Tremor according to criteria of the Study site * 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 Unified Parkinson's Disease Rating Scale with therapy in L-dopa (levodopa) * 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 women of childbearing age * Person with coagulopathies * Abuse of drugs or alcohol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the therapeutic window's boundaries when stimulating in specific angular directions, and comparison to those obtained when stimulating in all directions. | up to one hour during surgery | A therapeutic window is defined as the difference between the electrical current threshold at which a desired therapeutic effect is obtained and the current threshold at which side effects appear. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrical functionality of the study device during the test phase | 1 day | The electrical integrity of the device will be measured before and after its use, to confirm that it was functional throughout the test phase. |
Countries
Switzerland
Outcome results
None listed