Parkinson's DiseaseiMRINCT00792532
Use of Interventional MRI for Implantation of Deep Brain Stimulator Electrodes
An observational study of Parkinson's Disease and Dystonia, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to gather observational data on an already FDA-approved implantation technique for deep brain stimulation (DBS) in which the entire surgery is performed within an MRI scanner ("interventional MRI", or iMRI). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinson's Disease, Dystonia
- What is being tested?
- interventional MRI for implantation of DBS electrodes and DBS electrodes
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Mar 2019
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's disease, eligible for DBS
Who may be able to join
- Diagnosis of idiopathic PD with clinically significant motor fluctuations despite maximized anti-Parkinsonian therapy. This will be based on medical history, neurologic examination (the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia), and response to anti-Parkinsonian therapy.
- Approximately 5 years' duration, relative to the date of surgery, since diagnosis of PD.
- Age >20 inclusive, on date of surgery.
- The subject is ambulatory in their best on time (not wheelchair bound).
- The subject is medically able to undergo the surgery as determined by clinical and laboratory evaluations and any other evaluations that are part of the standard practice at the institution in which the subject is to undergo surgery (e.g., subjects will have normal coagulation tests and normal platelet levels).
- The subject is expected to be able to comply with and understand the required visit schedule and all required tests and procedures.
- Signed IRB-approved informed consent is obtained before any study-specific procedure, including assessments required during the eligibility evaluation period.
Who cannot join
- In the judgment of the investigator, a history of any clinically significant medical, psychiatric, or laboratory abnormality for which participation in the study would pose a safety risk to the subject.
- History of treatment of PD by any procedure involving intracranial surgery or implantation of a device.
- MRI of the brain within 12 months before the surgery which demonstrates an intracranial abnormality that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the DBS target area).
- Any disorder that precludes a surgical procedure (e.g., signs of sepsis or inadequately treated infection) or alters wound healing.
- Receipt of antiplatelet agents for at least 10 days prior surgery.
- Significant cognitive impairment based on investigator assessment during the eligibility evaluation period.
Show all 29Show fewer
- History of significant psychiatric illness, epilepsy, or Alzheimer's disease.
- Active drug or alcohol abuse.
- Pregnancy or lack of effective contraception in women of childbearing potential defined as one year post-menopausal or surgically sterile.
- Treatment with non anti-Parkinsonian agents (e.g., atypical neuroleptics) that may affect symptoms of PD within 60 days before entering the study.
- Any medical disability (e.g., severe degenerative arthritis, compromised nutritional state, severe peripheral neuropathy) that would interfere with the assessment of safety and efficacy in this trial.
- Inability to follow-up with post-operative study visits
- Inability to speak or read English
- Dystonia Inclusion Criteria
- Dystonia diagnosed by a movement disorders neurologist
- Significant functional impairment despite optimal medical management, including failed botulinum toxin therapy if appropriate
- Age >20 years inclusive, on date of surgery.
- The subject is medically able to undergo the surgery as determined by clinical and laboratory evaluations and any other evaluations that are part of the standard practice at the institution in which the subject is to undergo surgery (e.g., subjects will have normal coagulation tests and normal platelet levels).
- The subject is able to comply with and understand the required visit schedule and all required tests and procedures.
- Signed IRB-approved informed consent is obtained before any study-specific procedure, including assessments required during the eligibility evaluation period.
- Any disorder that precludes a surgical procedure (e.g., signs of sepsis or inadequately treated infection) or alters wound healing.
- Receipt of antiplatelet agents for at least 10 days prior surgery.
- Significant cognitive impairment based on investigator assessment during the eligibility evaluation period.
- History of significant psychiatric illness, epilepsy, or Alzheimer's disease.
- Active drug or alcohol abuse.
- Pregnancy or lack of effective contraception in women of childbearing potential defined as one year post-menopausal or surgically sterile.
- Any medical disability (e.g., severe degenerative arthritis, compromised nutritional state, severe peripheral neuropathy) that would interfere with the assessment of safety and efficacy in this trial.
- Inability to follow-up with post-operative study visits
- Inability to speak or read English
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
The purpose of this study is to gather observational data on an already FDA-approved implantation technique for deep brain stimulation (DBS) in which the entire surgery is performed within an MRI scanner ("interventional MRI", or iMRI). With this surgical technique, the patient is fully asleep (under general anesthesia) during DBS implantation. The standard method for the placement of deep brain stimulators does not use MRI during the actual DBS placement. The standard method involves placement of a rigid frame on the patient's head, performance of a short MRI scan, transport to the operating room, placement of the DBS electrodes in the operating room, and return to the MRI suite for another MR to confirm correct electrode placement. In the standard method, the patient must be awake for 2-4 hours in the operating room to have "brain mapping" performed, where the brain target is confirmed by passing "microelectrodes" (thin wires) into the brain to record its electrical activity. In the standard method, general anesthesia is not required. With the iMRI technique, the surgery is guided entirely by MRI images performed multiple times as the DBS electrode is advanced. This eliminates the need for the patient to be awake, and eliminates the need for passing microelectrodes into the brain before placing the permanent DBS electrode.
Read the detailed description
Deep brain stimulation (DBS) is an increasingly common surgical technique for the treatment of Parkinson's disease and dystonia. The current technical approach to DBS implantation involves frame-based stereotaxy. In this method, a stereotactic frame is rigidly fixed to the patient's skull, an MRI is obtained, an anatomic target is identified, and the coordinates of the target in stereotactic space are calculated. Instruments are mounted on the stereotactic frame that point to the calculated coordinate. However, due to the inherent inaccuracies in standard frame-based stereotaxy, a complex 6-hour procedure then ensues to "map" the brain target with microelectrodes, place the lead, and return to the MR unit to confirm proper placement.
The goal of this project is to gather observational data on the iMRI DBS implantation technique and clinical outcomes. This already FDA-approved implantation technique for DBS will take place entirely within the Phillips 1.5T and a Siemens 3T open magnet MRI machine. Prior to study initiation, instrumentation and MR protocols were tested using a phantom head. In the proposed project, subthalamic nucleus or globus pallidus DBS implantations will be performed bilaterally in patients with Parkinson's disease or dystonia. Patients will be under general anesthesia. Targeting and lead verification are performed with imaging alone, without physiologic mapping. Data is to be gathered on the following: operative time, degree of benefit with bilateral implantation (changes in standard rating scales of motor disability), DBS voltage requirements, complications), and electrode location by MR. These measures will be compared with our historical controls, previously entered into our research database, in which electrodes were placed by the standard methods. We expect that the use of near real time MR will improve the speed and accuracy of DBS implantation, and eliminate the need for invasive physiological monitoring.
All of the study participants will be getting iMRI DBS implantation as a part of their standard of care and agree to have additional study data collected
- Conditions
- Parkinson's Disease, Dystonia
- Being tested
- interventional MRI for implantation of DBS electrodes, DBS electrodes
- Medical subject headings
- Parkinson Disease, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventional MRI for implantation of DBS electrodesProcedure or surgery
Also called interventional MR
DBS implantation will be performed entirely within a Phillips 3T MRI scanner
DBS electrodesDevice
Deep brain stimulation (DBS) electrodes
| Study group | Role | What they receive |
|---|---|---|
| iMRI | Not described Receives: Procedure: interventional MRI for implantation of DBS electrodes; Device: DBS electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson's disease: The degree of benefit from baseline off medication UPDRS(part III) motor score to postoperative off medication scores at 12 months with stimulation on.
Measured: 12 months post-surgery
Dystonia: The percent change from baseline in the Burk-Fahn-Marsden Dystonia rating scale movement subscore to the 12 month postoperative subscore
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startJul 2003
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- MRI Interventions, Inc.
- Responsible party
- Sponsor
- Investigators
- Philip Starr, M.D., Ph.D., Principal investigator, University of California, San Francisco; SFVAMCPaul Larson, M.D., Principal investigator, University of California, San Francisco; SFVAMCJill L Ostrem, MD, Principal investigator, University of California San Francisco, SFVAMCAlastair J Martin, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792532
- Sponsor's protocol ID
- iMRI
- Acronym
- iMRI
- Status last verified
- Dec 2019
- First submitted
- 14 Nov 2008
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Martin AJ, Larson PS, Ostrem JL, Keith Sootsman W, Talke P, Weber OM, Levesque N, Myers J, Starr PA. Placement of deep brain stimulator electrodes using real-time high-field interventional magnetic resonance imaging. Magn Reson Med. 2005 Nov;54(5):1107-14. doi: 10.1002/mrm.20675.
PubMed 16206144Ostrem JL, Ziman N, Galifianakis NB, Starr PA, Luciano MS, Katz M, Racine CA, Martin AJ, Markun LC, Larson PS. Clinical outcomes using ClearPoint interventional MRI for deep brain stimulation lead placement in Parkinson's disease. J Neurosurg. 2016 Apr;124(4):908-16. doi: 10.3171/2015.4.JNS15173. Epub 2015 Oct 23.
PubMed 26495947Starr PA, Markun LC, Larson PS, Volz MM, Martin AJ, Ostrem JL. Interventional MRI-guided deep brain stimulation in pediatric dystonia: first experience with the ClearPoint system. J Neurosurg Pediatr. 2014 Oct;14(4):400-8. doi: 10.3171/2014.6.PEDS13605. Epub 2014 Aug 1.
PubMed 25084088
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Interventional MRI for Implantation of Deep Brain Stimulator Electrodes
- ClinicalTrials.gov ID
- NCT00792532
- Acronym / sponsor ID
- iMRI / iMRI
- Conditions
- Parkinson's Disease, Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- MRI Interventions, Inc.
- Study start
- Jul 2003 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 18 Nov 2008 (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 gather observational data on an already FDA-approved implantation technique for deep brain stimulation (DBS) in which the entire surgery is performed within an MRI scanner ("interventional MRI", or iMRI). With this surgical technique, the patient is fully asleep (under general anesthesia) during DBS implantation. The standard method for the placement of deep brain stimulators does not use MRI during the actual DBS placement. The standard method involves placement of a rigid frame on the patient's head, performance of a short MRI scan, transport to the operating room, placement of the DBS electrodes in the operating room, and return to the MRI suite for another MR to confirm correct electrode placement. In the standard method, the patient must be awake for 2-4 hours in the operating room to have "brain mapping" performed, where the brain target is confirmed by passing "microelectrodes" (thin wires) into the brain to record its electrical activity. In the standard method, general anesthesia is not required. With the iMRI technique, the surgery is guided entirely by MRI images performed multiple times as the DBS electrode is advanced. This eliminates the need for the patient to be awake, and eliminates the need for passing microelectrodes into the brain before placing the permanent DBS electrode.
Detailed description
Deep brain stimulation (DBS) is an increasingly common surgical technique for the treatment of Parkinson's disease and dystonia. The current technical approach to DBS implantation involves frame-based stereotaxy. In this method, a stereotactic frame is rigidly fixed to the patient's skull, an MRI is obtained, an anatomic target is identified, and the coordinates of the target in stereotactic space are calculated. Instruments are mounted on the stereotactic frame that point to the calculated coordinate. However, due to the inherent inaccuracies in standard frame-based stereotaxy, a complex 6-hour procedure then ensues to "map" the brain target with microelectrodes, place the lead, and return to the MR unit to confirm proper placement.
The goal of this project is to gather observational data on the iMRI DBS implantation technique and clinical outcomes. This already FDA-approved implantation technique for DBS will take place entirely within the Phillips 1.5T and a Siemens 3T open magnet MRI machine. Prior to study initiation, instrumentation and MR protocols were tested using a phantom head. In the proposed project, subthalamic nucleus or globus pallidus DBS implantations will be performed bilaterally in patients with Parkinson's disease or dystonia. Patients will be under general anesthesia. Targeting and lead verification are performed with imaging alone, without physiologic mapping. Data is to be gathered on the following: operative time, degree of benefit with bilateral implantation (changes in standard rating scales of motor disability), DBS voltage requirements, complications), and electrode location by MR. These measures will be compared with our historical controls, previously entered into our research database, in which electrodes were placed by the standard methods. We expect that the use of near real time MR will improve the speed and accuracy of DBS implantation, and eliminate the need for invasive physiological monitoring.
All of the study participants will be getting iMRI DBS implantation as a part of their standard of care and agree to have additional study data collected
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iMRI | – | Procedure: interventional MRI for implantation of DBS electrodes, Device: DBS electrodes |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease, eligible for DBS
Key inclusion criteria (7 listed)
- Diagnosis of idiopathic PD with clinically significant motor fluctuations despite maximized anti-Parkinsonian therapy. This will be based on medical history, neurologic examination (the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia), and response to anti-Parkinsonian therapy.
- Approximately 5 years' duration, relative to the date of surgery, since diagnosis of PD.
- Age >20 inclusive, on date of surgery.
- The subject is ambulatory in their best on time (not wheelchair bound).
- The subject is medically able to undergo the surgery as determined by clinical and laboratory evaluations and any other evaluations that are part of the standard practice at the institution in which the subject is to undergo surgery (e.g., subjects will have normal coagulation tests and normal platelet levels).
Key exclusion criteria (29 listed)
- In the judgment of the investigator, a history of any clinically significant medical, psychiatric, or laboratory abnormality for which participation in the study would pose a safety risk to the subject.
- History of treatment of PD by any procedure involving intracranial surgery or implantation of a device.
- MRI of the brain within 12 months before the surgery which demonstrates an intracranial abnormality that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the DBS target area).
- Any disorder that precludes a surgical procedure (e.g., signs of sepsis or inadequately treated infection) or alters wound healing.
- Receipt of antiplatelet agents for at least 10 days prior surgery.
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 |
|---|---|---|
| interventional MRI for implantation of DBS electrodesAlso: interventional MRDBS implantation will be performed entirely within a Phillips 3T MRI scanner | Procedure or surgery | iMRI |
| DBS electrodesDeep brain stimulation (DBS) electrodes | Device | iMRI |
Primary outcome
Parkinson's disease: The degree of benefit from baseline off medication UPDRS(part III) motor score to postoperative off medication scores at 12 months with stimulation on.
Time frame: 12 months post-surgery
Dystonia: The percent change from baseline in the Burk-Fahn-Marsden Dystonia rating scale movement subscore to the 12 month postoperative subscore
Time frame: 12 months post-surgery
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 18 Dec 2019.
- Results publication: PubMed 16206144Martin AJ, Larson PS, Ostrem JL, Keith Sootsman W, Talke P, Weber OM, Levesque N, Myers J, Starr PA. Placement of deep brain stimulator electrodes using real-time high-field interventional magnetic resonance imaging. Magn Reson Med. 2005 Nov;54(5):1107-14. doi: 10.1002/mrm.20675.
- Derived from this study: PubMed 26495947Ostrem JL, Ziman N, Galifianakis NB, Starr PA, Luciano MS, Katz M, Racine CA, Martin AJ, Markun LC, Larson PS. Clinical outcomes using ClearPoint interventional MRI for deep brain stimulation lead placement in Parkinson's disease. J Neurosurg. 2016 Apr;124(4):908-16. doi: 10.3171/2015.4.JNS15173. Epub 2015 Oct 23.
- Derived from this study: PubMed 25084088Starr PA, Markun LC, Larson PS, Volz MM, Martin AJ, Ostrem JL. Interventional MRI-guided deep brain stimulation in pediatric dystonia: first experience with the ClearPoint system. J Neurosurg Pediatr. 2014 Oct;14(4):400-8. doi: 10.3171/2014.6.PEDS13605. Epub 2014 Aug 1.
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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.
Philip Starr, M.D., Ph.D. principal investigator
University of California, San Francisco; SFVAMC
Paul Larson, M.D. principal investigator
University of California, San Francisco; SFVAMC
Jill L Ostrem, MD principal investigator
University of California San Francisco, SFVAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Dystonia, run by University of California, San Francisco at 1 site in United States.
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 7 inclusion and 29 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 18 Dec 2019. 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 United States. 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?
Parkinson's disease: The degree of benefit from baseline off medication UPDRS(part III) motor score to postoperative off medication scores at 12 months with stimulation on. (time frame: 12 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00792532, which also lists 3 linked publications.
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 18 Dec 2019.