Parkinson's DiseaseNCT01764815
Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation (DBS) Leads
A study testing directSTN Acute lead connected to external neurostimulator 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, 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. 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?
- directSTN Acute lead connected to external neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2012to Nov 2013
- 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
- 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)
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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 women 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 Stimulation During the Implantation of Deep Brain Stimulation Leads for the Treatment of Movement Disorders
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.
- Conditions
- Parkinson's Disease, Essential Tremor
- Being tested
- directSTN Acute lead connected to external neurostimulator
- 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.
directSTN Acute lead connected to external neurostimulatorDevice
Test phase will be performed intra-operatively, prior to chronic lead implant
| Study group | Role | What they receive |
|---|---|---|
| Directional lead | Experimental | Not described Receives: Device: directSTN Acute lead connected to external neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the therapeutic window's boundaries when stimulating in specific angular directions, and comparison to those obtained when stimulating in all directions.
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.
Measured: up to one hour during surgery
Secondary outcomes (1)
Electrical functionality of the study device during the test phase
The electrical integrity of the device will be measured before and after its use, 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 posted10 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionNov 2013
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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aleva Neurotherapeutics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudio Pollo, PD, Dr. med, Principal investigator, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764815
- Sponsor's protocol ID
- KEK 072-12
- Other IDs
- CIV-12-08-008482
- Status last verified
- Jun 2017
- First submitted
- 26 Dec 2012
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
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 Stimulation During the Implantation of Deep Brain Stimulation Leads for the Treatment of Movement Disorders
- ClinicalTrials.gov ID
- NCT01764815
- Acronym / sponsor ID
- KEK 072-12
- Conditions
- Parkinson's Disease, Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Aleva Neurotherapeutics SAIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Jan 2013 (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, 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Directional lead | Experimental | Device: directSTN Acute lead connected to external neurostimulator |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is indicated to undergo DBS for Parkinson's disease or Essential Tremor according to criteria of the Study site
- For Parkinson Disease:
- For Essential Tremor:
- Person has given his/her written consent
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 |
|---|---|---|
| directSTN Acute lead connected to external neurostimulatorTest phase will be performed intra-operatively, prior to chronic lead implant | Device | Directional lead |
Primary outcome
Measurement of the therapeutic window's boundaries when stimulating in specific angular directions, and comparison to those obtained when stimulating in all directions.
Time frame: 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.
1 secondary outcome
Electrical functionality of the study device during the test phase
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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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, PD, Dr. med 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 directSTN Acute lead connected to external neurostimulator 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 therapeutic window's boundaries when stimulating in specific angular directions, and comparison to those obtained when stimulating in all 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.