Idiopathic Parkinson's Disease (PD)NCT01883973
MER Versus MRI Guidance DBS in Parkinson's Disease
An observational study of Idiopathic Parkinson's Disease (PD), run by Baylor College of Medicine at 1 site in United States.
Trial summary
Most leading academic centers including Baylor College of Medicine (BCM) perform deep brain stimulation surgery in the awake patient using microelectrode recording to guide final electrode placement. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Idiopathic Parkinson's Disease (PD)
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2014
- 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 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients between the ages of 30 and 79 Diagnosis of idiopathic Parkinson's disease
Who may be able to join
- Determined to be candidates for subthalamic nucleus (STN) or Globus pallidus (GPi) DBS by consensus recommendation of a multidisciplinary team as evidenced by:
- Ability to provide informed consent as determined by preoperative neuropsychological assessment
- Optimized medically by a neurologist who is an expert in the treatment of movement disorders.
- Persistent motor symptoms which are not effectively controlled with optimal medical management. These symptoms may include levodopa-induced dyskinesias, tremor, or fluctuations in the effectiveness of levodopa throughout the day.
Who cannot join
- Dementia
- Previous intracranial surgery
- Intracranial tumor
- Lack of ability to provide informed consent as determined by preoperative neuropsychological assessment
- Medical co-morbidities that would make the patient a poor surgical candidate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study of Deep Brain Stimulation (DBS) Implantation Using A Microelectrode-Guided Technique Versus DBS Implantation Using MRI Guidance Alone
Most leading academic centers including Baylor College of Medicine (BCM) perform deep brain stimulation surgery in the awake patient using microelectrode recording to guide final electrode placement. Microelectrode recording is a means of analyzing the electrical activity of the brain, and assessing whether we have found the target for the deep brain stimulator electrode. However, no evidence exists that microelectrode recording improves patient outcomes. The use of microelectrode recording does extend the duration of surgery and there is evidence to suggest that microelectrode recording may increase the risk of bleeding in the brain during surgery.
Read the detailed description
Patients who have been randomized into Group 1 will undergo DBS implantation while awake. On the morning of surgery, the patient will undergo placement of the stereotactic head frame under local anesthesia. A CT scan will be performed for stereotactic planning, which will be fused to a preoperatively obtained MRI. The coordinates for the planned target will be selected using standard coordinates based on known relationships with the anterior commissure - posterior commissure plane, along with anatomical structures visualized on the MRI scan.
The surgery will be performed with the patient awake. Two simultaneous microelectrode tracks will be used for each DBS electrode to be implanted. If neither electrophysiological recording is adequate, additional MER tracks may be performed. Macro-stimulation will also be used to evaluate for clinical efficacy and stimulation induced side effects. The DBS electrode will be placed into the track with the optimal electrophysiological and clinical findings. The identical procedure will be followed for the contralateral side. A post-operative stereotactic CT scan will be performed to assess lead location and evaluate for intracranial bleeding.
Patients who have been randomized into Group 2 will undergo DBS implantation under general anesthesia in an operating room equipped with an intraoperative MRI. Once under anesthesia the patient will be placed into a rigid head holder, and an MRI scan will be obtained to register the navigation system. The location for the holes in the skull will be identified, and the surgery will be commenced. Once the holes have been made in the skull and the dura has been opened, a second MRI scan will be obtained to identify the target. A ceramic stylet will then be stereotactically introduced to the target, and a third MRI sequence will be performed to verify the stylet is indeed at the desired target. The DBS electrode will then be implanted after removing the stylet. A post-operative stereotactic CT scan will be performed to assess lead location and evaluate for intracranial bleeding.
Neither of the surgical groups will undergo investigational procedures. Both surgical techniques utilize FDA approved devices, used in the manner for which FDA approval was given. They represent two different, but both accepted, means for implanting deep brain stimulator electrodes.
- Conditions
- Idiopathic Parkinson's Disease (PD)
- Keywords
- PD, DBS
- 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 group | Role | What they receive |
|---|---|---|
| MER guidance | Will undergo DBS implantation in the awake state using a frame based stereotactic technique and intraoperative microelectrode recording to guide final lead placement. | |
| MRI Guidance | Will undergo DBS implantation under general anesthesia using anatomical targeting in an operating room equipped with an intraoperative MRI to guide electrode placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage improvement in the UPDRS part III motor score
The primary outcome measure for this study is the percentage improvement in the Unified Parkinson Disease Rating Scale (UPDRS) part III motor score from baseline to 6 months in patients who receiving stimulation in the "OFF" medication state. Secondary outcome measures include rate of radiographically visible intracranial hemorrhage and changes in neurocognitive function and quality of life testing. The student's two sample t-test will be used to perform the statistically comparisons.
Measured: from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMay 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashwin Viswanathan, Baylor College of Medicine
- Investigators
- Ashwin Viswanathan, MD, Principal investigator, Baylor College of MedicineJoohi Jimenez-Shahed, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883973
- Sponsor's protocol ID
- H-27630
- Status last verified
- Nov 2020
- First submitted
- 19 Jun 2013
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Deep Brain Stimulation (DBS) Implantation Using A Microelectrode-Guided Technique Versus DBS Implantation Using MRI Guidance Alone
- ClinicalTrials.gov ID
- NCT01883973
- Acronym / sponsor ID
- H-27630
- Conditions
- Idiopathic Parkinson's Disease (PD)
- Keywords
- PD, DBS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Jun 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.
Most leading academic centers including Baylor College of Medicine (BCM) perform deep brain stimulation surgery in the awake patient using microelectrode recording to guide final electrode placement. Microelectrode recording is a means of analyzing the electrical activity of the brain, and assessing whether we have found the target for the deep brain stimulator electrode. However, no evidence exists that microelectrode recording improves patient outcomes. The use of microelectrode recording does extend the duration of surgery and there is evidence to suggest that microelectrode recording may increase the risk of bleeding in the brain during surgery.
Detailed description
Patients who have been randomized into Group 1 will undergo DBS implantation while awake. On the morning of surgery, the patient will undergo placement of the stereotactic head frame under local anesthesia. A CT scan will be performed for stereotactic planning, which will be fused to a preoperatively obtained MRI. The coordinates for the planned target will be selected using standard coordinates based on known relationships with the anterior commissure - posterior commissure plane, along with anatomical structures visualized on the MRI scan.
The surgery will be performed with the patient awake. Two simultaneous microelectrode tracks will be used for each DBS electrode to be implanted. If neither electrophysiological recording is adequate, additional MER tracks may be performed. Macro-stimulation will also be used to evaluate for clinical efficacy and stimulation induced side effects. The DBS electrode will be placed into the track with the optimal electrophysiological and clinical findings. The identical procedure will be followed for the contralateral side. A post-operative stereotactic CT scan will be performed to assess lead location and evaluate for intracranial bleeding.
Patients who have been randomized into Group 2 will undergo DBS implantation under general anesthesia in an operating room equipped with an intraoperative MRI. Once under anesthesia the patient will be placed into a rigid head holder, and an MRI scan will be obtained to register the navigation system. The location for the holes in the skull will be identified, and the surgery will be commenced. Once the holes have been made in the skull and the dura has been opened, a second MRI scan will be obtained to identify the target. A ceramic stylet will then be stereotactically introduced to the target, and a third MRI sequence will be performed to verify the stylet is indeed at the desired target. The DBS electrode will then be implanted after removing the stylet. A post-operative stereotactic CT scan will be performed to assess lead location and evaluate for intracranial bleeding.
Neither of the surgical groups will undergo investigational procedures. Both surgical techniques utilize FDA approved devices, used in the manner for which FDA approval was given. They represent two different, but both accepted, means for implanting deep brain stimulator electrodes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MER guidance | – | –Will undergo DBS implantation in the awake state using a frame based stereotactic technique and intraoperative microelectrode recording to guide final lead placement. |
| MRI Guidance | – | –Will undergo DBS implantation under general anesthesia using anatomical targeting in an operating room equipped with an intraoperative MRI to guide electrode placement |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients between the ages of 30 and 79 Diagnosis of idiopathic Parkinson's disease
Key inclusion criteria (4 listed)
- Determined to be candidates for subthalamic nucleus (STN) or Globus pallidus (GPi) DBS by consensus recommendation of a multidisciplinary team as evidenced by:
Key exclusion criteria (5 listed)
- Dementia
- Previous intracranial surgery
- Intracranial tumor
- Lack of ability to provide informed consent as determined by preoperative neuropsychological assessment
- Medical co-morbidities that would make the patient a poor surgical candidate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
percentage improvement in the UPDRS part III motor score
Time frame: from baseline to 6 months
The primary outcome measure for this study is the percentage improvement in the Unified Parkinson Disease Rating Scale (UPDRS) part III motor score from baseline to 6 months in patients who receiving stimulation in the "OFF" medication state. Secondary outcome measures include rate of radiographically visible intracranial hemorrhage and changes in neurocognitive function and quality of life testing. The student's two sample t-test will be used to perform the statistically comparisons.
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 25 Nov 2020.
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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.
Ashwin Viswanathan, MD principal investigator
Baylor College of Medicine
Joohi Jimenez-Shahed, MD principal investigator
Baylor College of Medicine
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 Idiopathic Parkinson's Disease (PD), run by Baylor College of Medicine 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 4 inclusion and 5 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 25 Nov 2020. 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?
percentage improvement in the UPDRS part III motor score (time frame: from baseline to 6 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 25 Nov 2020.