Study Stopped
This study was structured in 2 phases, and was stopped after the first phase. The collected data will be used to improve the device and prepare future studies.
Evaluation of Directional Recording and Stimulation Using spiderSTN
2 other identifiers
interventional
6
1 country
1
Brief Summary
The purpose of this study is to provide proof-of-concept that directional stimulation and directional recording, in an intraoperative setting, is perceivable in a subject. The tests will be performed using a dedicated intraoperative lead connected to an external neuro-recorder/stimulator, during a deep brain stimulation implantation surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedJuly 2, 2017
June 1, 2017
5 months
August 24, 2016
June 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Measurement of the delivered electrical current at which a sustained side effect occurs, and compare the results from specific angular directions
This will be performed by independently stimulating electrodes which are oriented in different directions on the same spiderSTN lead, and assessing the patient's response.
up to one hour during surgery
Secondary Outcomes (2)
Measurement of the electrical current created by the neuronal activity coming from specific directions, and compare the results.
up to one hour during surgery
Electrical functionality of the study device during the test phase
1 day
Study Arms (1)
spiderSTN
EXPERIMENTALIt is an Intraoperative test during a deep brain stimulation surgery. The spiderSTN lead is implanted in a selected track in the brain, and is tested for stimulation and recording.
Interventions
The spiderSTN lead is inserted in a selected track in the brain, and is connected to external neuro-recorder/stimulator . Once the intraoperative test phase is completed, the test devices are removed and the DBS surgery resumes.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inselspital
Bern, 3030, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudio Pollo, Professor
Inselspital, Bern University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2016
First Posted
September 9, 2016
Study Start
September 1, 2016
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
July 2, 2017
Record last verified: 2017-06