Parkinson's DiseaseNCT02894567
Evaluation of Directional Recording and Stimulation Using spiderSTN
A study testing Intraoperative test during a deep brain stimulation surgery in people with Parkinson's Disease and Essential Tremor, run by Aleva Neurotherapeutics SA at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease, Essential Tremor
- What is being tested?
- Intraoperative test during a deep brain stimulation surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Directional Recording and Stimulation Using the spiderSTN During the Implantation of DBS Leads
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.
Read the detailed description
Deep brain stimulation (DBS) technique involves implanting electrodes using a stereotactic method and connecting them to a pulse generator to deliver a current in localized areas in the brain.
The optimum location for DBS electrodes is determined by pre-operative brain imaging, often combined with an intraoperative microelectrode recording/stimulating (MER) sequence. Current MER practice involves inserting micro-recording/stimulating electrodes into guide tubes in the brain and lowering them towards the target, performing recordings at selected steps. The recordings differ based on the types of neuronal structures they are passing through.Based on the recordings, some promising locations are further discriminated by stimulation using macro-electrodes, and the target for final lead placement is chosen.
The spiderSTN lead (Aleva Neurotherapeutics SA, Switzerland) is capable of recording and stimulating from both its inner and outer surface, allowing the user to steer the direction of stimulation during the target location phase. This will allow the neurosurgeon greater flexibility in investigating the balance between therapeutic benefits and stimulation-induced side effects at a given location.
This feasibility study is designed to explore the effect of directional stimulation and the ability to differentiate between stimulation induced side effects at a given location, during the DBS surgery. It will be proposed to patients who suffer from Parkinson disease (PD) or essential tremor (ET) and for whom DBS is indicated according to standard criteria at the hospital. It will be restricted to a limited number of patients (10), sufficient to assess the recording and stimulating capacity of the spiderSTN device. The patient undergoes the normal DBS surgery until the position for the final lead has been chosen. Then the spiderSTN test phase takes place. Once test phase is completed, the conventional DBS surgery resumes.
- Conditions
- Parkinson's Disease, Essential Tremor
- Being tested
- Intraoperative test during a deep brain stimulation surgery
- Medical subject headings
- Parkinson Disease, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative test during a deep brain stimulation surgeryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| spiderSTN | Experimental | It 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. Receives: Device: Intraoperative test during a deep brain stimulation surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
To assess the recording capabilities of the spiderSTN lead by correlating the results obtained from the neurologist's visual, real-time interpretation of the recorded neuronal activity, to a post-processing analysis of the actual signal recorded.
Measured: up to one hour during surgery
Electrical functionality of the study device during the test phase
The electrical integrity of the device will be measured before and after the test phase, to confirm that it was functional throughout the test phase.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aleva Neurotherapeutics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudio Pollo, Professor, Principal investigator, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894567
- Sponsor's protocol ID
- KEK 272-15
- Other IDs
- CIV-16-02-014704
- Status last verified
- Jun 2017
- First submitted
- 24 Aug 2016
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Directional Recording and Stimulation Using the spiderSTN During the Implantation of DBS Leads
- ClinicalTrials.gov ID
- NCT02894567
- Acronym / sponsor ID
- KEK 272-15
- Conditions
- Parkinson's Disease, Essential Tremor
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Aleva Neurotherapeutics SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Deep brain stimulation (DBS) technique involves implanting electrodes using a stereotactic method and connecting them to a pulse generator to deliver a current in localized areas in the brain.
The optimum location for DBS electrodes is determined by pre-operative brain imaging, often combined with an intraoperative microelectrode recording/stimulating (MER) sequence. Current MER practice involves inserting micro-recording/stimulating electrodes into guide tubes in the brain and lowering them towards the target, performing recordings at selected steps. The recordings differ based on the types of neuronal structures they are passing through.Based on the recordings, some promising locations are further discriminated by stimulation using macro-electrodes, and the target for final lead placement is chosen.
The spiderSTN lead (Aleva Neurotherapeutics SA, Switzerland) is capable of recording and stimulating from both its inner and outer surface, allowing the user to steer the direction of stimulation during the target location phase. This will allow the neurosurgeon greater flexibility in investigating the balance between therapeutic benefits and stimulation-induced side effects at a given location.
This feasibility study is designed to explore the effect of directional stimulation and the ability to differentiate between stimulation induced side effects at a given location, during the DBS surgery. It will be proposed to patients who suffer from Parkinson disease (PD) or essential tremor (ET) and for whom DBS is indicated according to standard criteria at the hospital. It will be restricted to a limited number of patients (10), sufficient to assess the recording and stimulating capacity of the spiderSTN device. The patient undergoes the normal DBS surgery until the position for the final lead has been chosen. Then the spiderSTN test phase takes place. Once test phase is completed, the conventional DBS surgery resumes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spiderSTN | Experimental | Device: Intraoperative test during a deep brain stimulation surgeryIt 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient foreseen to undergo DBS for Parkinson's disease or Essential Tremor according to routine criteria of the center.
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative test during a deep brain stimulation surgeryThe 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. | Device | spiderSTN |
Primary outcome
Measurement of the delivered electrical current at which a sustained side effect occurs, and compare the results from specific angular directions
Time frame: up to one hour during surgery
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.
2 secondary outcomes
Measurement of the electrical current created by the neuronal activity coming from specific directions, and compare the results.
Time frame: up to one hour during surgery
Electrical functionality of the study device during the test phase
Time frame: 1 day
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Pollo, Professor principal investigator
Inselspital, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative test during a deep brain stimulation surgery in people with Parkinson's Disease and Essential Tremor, run by Aleva Neurotherapeutics SA at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the delivered electrical current at which a sustained side effect occurs, and compare the results from specific angular directions (time frame: up to one hour during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.