Parkinson's DiseasePhase 1NCT01098565
Deep Brain Stimulation Effects Study
A Phase 1 study testing Study device HFR0001 in people with Parkinson's Disease, run by MedtronicNeuro at 1 site in Germany.
Trial summary
The purpose of this study is to provide proof-of-concept that the test product can perform as intended in an intra-operative setting and the responses to the test product are perceivable in a person. The study will also compare results of the test product to the commercially-available product. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Study device HFR0001
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Nov 2011
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is indicated for Activa® DBS implant for the treatment of Parkinson's disease and scheduled for surgery at the study site.
- Subject is willing to sign the informed consent to participate in the study.
- Subject is 18 years of age or older.
- Subject is a male or non-pregnant female.
- Subject has no factors that would put the subject at an additional risk for intra-operative or postoperative bleeding. This includes underlying disorders of the coagulation cascade (eg, hemophilia), disorders that affect platelet count or function (eg, Von Willebrand's disease), as well as administration of any anti-platelet or anti-coagulant medication in the 7 days prior to surgery, or any history of anticoagulant or aspirin use, that in the view of the neurosurgeon or neurologist would place the subject at an increased risk for intra-operative or postoperative bleeding.
Who cannot join
- Subject is indicated for DBS for treating a disorder other than Parkinson's disease.
- Subject has any medical contraindications to undergoing DBS surgery, (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery).
- Subject has a history of hemorrhagic stroke.
- Subject has a history of a neurosurgical ablation procedure.
- Subject is currently enrolled in or plans to enroll in any concurrent study that may confound the results of this study, as determined by the investigator or Medtronic.
- Subject has a diagnosis of acute myocardial infarction or cardiac arrest less than or equal to 6 months prior to the screening testing.
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- Subject has a history of a seizure disorder
- Subject requires short surgery time due to general health issues, as determined by the investigator.
- Subject is a woman who is pregnant or planning to become pregnant, or a woman of child-bearing potential, who is not using a medically-acceptable method of birth control. Women of child-bearing potential must undergo a pregnancy test, with a clear negative result, no more than 7 days prior to the investigational procedure visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Brain Stimulation Effects: Human Proof-of-Concept Study
The purpose of this study is to provide proof-of-concept that the test product can perform as intended in an intra-operative setting and the responses to the test product are perceivable in a person. The study will also compare results of the test product to the commercially-available product.
Hypothesis: the test product will elicit successful test results in over 90% of test product.
- Conditions
- Parkinson's Disease
- Being tested
- Study device HFR0001
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study device HFR0001Device
Study device will be tested for up to 2 hours prior to chronic device implant.
| Study group | Role | What they receive |
|---|---|---|
| Study device arm | Experimental | Not described Receives: Device: Study device HFR0001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The HFR0001 device can elicit distinct intra-operative responses in subject symptoms.
Responses include testing parameters and symptom effects
Measured: 9 months
Secondary outcomes (1)
Adverse events that occur with the acute implantation and intra-operative testing of the study device.
Characterization of all adverse events for all subjects from the beginning of the implant procedure through study discontinuation.
Measured: 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: The goal of collecting proof-of-concept information was met through additional modeling studies, new published evidence and information collected from the study
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 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- H. Maximilian Mehdorn, MD, PhD, Principal investigator, University Clinics Kiel, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098565
- Sponsor's protocol ID
- 1654
- Status last verified
- Aug 2013
- First submitted
- 25 Mar 2010
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation Effects: Human Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT01098565
- Acronym / sponsor ID
- 1654
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The goal of collecting proof-of-concept information was met through additional modeling studies, new published evidence and information collected from the study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 2 Apr 2010 (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 the test product can perform as intended in an intra-operative setting and the responses to the test product are perceivable in a person. The study will also compare results of the test product to the commercially-available product.
Hypothesis: the test product will elicit successful test results in over 90% of test product.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study device arm | Experimental | Device: Study device HFR0001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is indicated for Activa® DBS implant for the treatment of Parkinson's disease and scheduled for surgery at the study site.
- Subject is willing to sign the informed consent to participate in the study.
- Subject is 18 years of age or older.
- Subject is a male or non-pregnant female.
- Subject has no factors that would put the subject at an additional risk for intra-operative or postoperative bleeding. This includes underlying disorders of the coagulation cascade (eg, hemophilia), disorders that affect platelet count or function (eg, Von Willebrand's disease), as well as administration of any anti-platelet or anti-coagulant medication in the 7 days prior to surgery, or any history of anticoagulant or aspirin use, that in the view of the neurosurgeon or neurologist would place the subject at an increased risk for intra-operative or postoperative bleeding.
Key exclusion criteria (9 listed)
- Subject is indicated for DBS for treating a disorder other than Parkinson's disease.
- Subject has any medical contraindications to undergoing DBS surgery, (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery).
- Subject has a history of hemorrhagic stroke.
- Subject has a history of a neurosurgical ablation procedure.
- Subject is currently enrolled in or plans to enroll in any concurrent study that may confound the results of this study, as determined by the investigator or Medtronic.
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 |
|---|---|---|
| Study device HFR0001Study device will be tested for up to 2 hours prior to chronic device implant. | Device | Study device arm |
Primary outcome
The HFR0001 device can elicit distinct intra-operative responses in subject symptoms.
Time frame: 9 months
Responses include testing parameters and symptom effects
1 secondary outcome
Adverse events that occur with the acute implantation and intra-operative testing of the study device.
Time frame: 9 months.
Results and safety
The study was stopped early (reason given: The goal of collecting proof-of-concept information was met through additional modeling studies, new published evidence and information collected from the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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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.
H. Maximilian Mehdorn, MD, PhD principal investigator
University Clinics Kiel, Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Study device HFR0001 in people with Parkinson's Disease, run by MedtronicNeuro at 1 site in Germany.
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 5 inclusion and 9 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 Aug 2013. 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 Germany. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The goal of collecting proof-of-concept information was met through additional modeling studies, new published evidence and information collected from the study). 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?
The HFR0001 device can elicit distinct intra-operative responses in subject symptoms. (time frame: 9 months). 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 Aug 2013.