MER Versus MRI Guidance DBS in Parkinson's Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - 79 |
| Updated: | 4/2/2016 |
| Start Date: | May 2011 |
| Contact: | Ashwin Viswanathan, MD |
| Email: | ashwinv@bcm.edu |
| Phone: | 713-798-3739 |
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.
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.
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.
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.
Inclusion Criteria:
- Determined to be candidates for subthalamic nucleus (STN) or Globus pallidus (GPi)
DBS by consensus recommendation of a multidisciplinary team as evidenced by:
1. Ability to provide informed consent as determined by preoperative
neuropsychological assessment
2. Optimized medically by a neurologist who is an expert in the treatment of
movement disorders.
3. 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.
Exclusion Criteria:
- 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
We found this trial at
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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