British Journal
o f Neurosurgery
(Manuscript ID: CBJN-2012-0340.R2)Deep brain stimulation for Parkinson’s disease using frameless
technology
Chun-Yuan Cheng,1,2 Ming-Tai Hsing,2 Yung-Hsiang Chen,3,4 Sey-Lin Wu,2 Hiu
Ngar Sy,2 Chien-Min Chen,2 Yu-Jen Yang,2 Meng-Chih Lee1,5,*
1Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, 2Divisions
of Neurosurgery, Neurology, and Surgery, Department of Surgery, Changhua Christian Hospital, Changhua, Taiwan, 3Graduate Institute of Integrated Medicine,
China Medical University, Taichung, Taiwan, 4Department of Medical Research,
China Medical University Hospital, Taichung, Taiwan, and 5Taichung Hospital,
Department of Health, Taichung, Taiwan
*Correspondence to: Dr. Meng-Chih Lee
Taichung Hospital, Department of Health
Institute of Medicine, Chung Shan Medical University No.110, Sec. 1, Jianguo N. Road
Taichung 40201, Taiwan
Fax: +886-4-22037690, E-mail: [email protected]
ABSTRACT
Historically deep brain stimulation (DBS) for Parkinson’s disease (PD) has been performed by frame-based stereotaxy. However, recently the option of frameless stereotaxy has become available. This avoids the potential discomfort the patient may experience because of the frame fixed to the head. This study compared clinical outcomes of DBS performed using frame-based and frameless procedures for PD patients. Twelve patients underwent DBS operations; from these patients, 6 underwent frame-based and 6 underwent frameless DBS operations, and assessed 6 months later. Operation time, subthalamic electrode contact length, microelectrode recording (MER) tracts, and unified PD rating scale scores were evaluated and the scores were compared. This small study found no differences between frameless or frame based DBS, and concludes that framless system maybe an acceptable alternative.
INTRODUCTION
Deep brain stimulation (DBS) is an effective modality for treating movement
disorders, including advanced Parkinson’s disease (PD).3 A proportion of PD patients
tolerate long term medical therapy poorly developing unpredictable on and
drug-off states, and drug-induced dyskinesia. In 1987, Benabid et al. published his
milestone paper on DBS for PD resulting in the resurgence of this technique in the
treatment of movement disorder.6 Accurately placing DBS leads into the targeted
deep nuclei is an essential step for successful DBS therapy in patients with PD.7
Misplacement of leads may result in unsatisfactory symptom improvement, adverse
stimulation effects, or even therapy failure and has been considered as one of the main
complications of DBS therapy. A full multidisciplinary pre-operative assessment is
necessary, and the techniques employed have to take into consideration effects such
as brain shift during stereotactic implantation.
Classically the procedure is performed using a stereotactic frame into which the
patient’s head is fixed; imaging and then implantation of electrodes are performed, the
latter with the patient awake. It can be a lengthy procedure, making it uncomfortable
and tiring. Frameless stereotaxy is a solution that can reduce the discomfort
experienced during these procedures.13-18
frame-based and frameless DBS operations in PD patients.
METHODS
Twelve patients with PD from Changhua Christian Hospital, Changhua, Taiwan
were involved in this study. These patients were undergoing regular follow-ups with
movement disorder specialists (SLW and HNS). These patients had been diagnosed
with PD more than 5 years ago and had responded well to dopamine treatment.
Moreover, they had more than one of the following conditions: unpredictable drug-off
state, drug-induced dyskinesia, and intractable tremors. The computed tomography
(CT) was used for registration in either frame-based or frameless procedures. Detailed
brain magnetic resonance imaging (MRI, Philips 2.0 T) studies were performed. MRI sequences with turbo [or fast] spin-echo (T2 TSE/FSE) (flip angle, 90°;
repetition time [TR], 4238; echo time [TE], 90) and proton density (PD)-weighted
MRI (TR, 4238; TE, 20; field of view [FOV], 30 mm × 30 mm) were used for red
nucleus visualisation and subthalamic nucleus (STN) determination, respectively.
Medtronic FrameLink software was used for image fusion. Microelectrode recording (MER) was used (Leadpoint), to ensure that optimal tracts are chosen.19
For 6 patients who underwent the frame-based procedure, on the operation day, a
placed parallel to the lateral canthal-meatal line, and fixed as symmetrically as
possible.
The 6 other patients underwent a frameless procedure, using the NexFrame with
the Medtronic Stealth Treon frameless navigation system (Medtronic, USA). In addition, before the operation, brain MRI studies and brain CT (0.6-mm thick slices
from below the mandible to above the vertex parallel cutting) were performed after
fixing 5 fiducial bone screws.
In all 12 cases, MER was used with Leadpoint; per-operatively macrostimulation was used to confirm therapeutic effect and absence of side effects.
Post-procedural brain CT was performed. In each patient, an implant pulse generator
(IPG) was subcutaneously implanted onto the patient’s left subclavian area and
connected with 2 electrodes. The generator was switched on 4 weeks after completing
the DBS procedure. Programming for IPG was routinely adjusted at the neurology
outpatient department. The patients were followed up for a minimum of 6 months.
RESULTS
Table 1 shows the baseline characteristics for both treatment groups. The patients who underwent the frame-based procedure did not significantly differ from
those who underwent the frameless procedure with respect to age, gender distribution,
groups, and as expected levodopa dosage decreased after the operation. The unified
Parkinson’s disease rating scale (UPDRS) score also improved after the DBS
operation (in condition on optimal medication) (Figures 1 and 2).
There was a significant reduction in operation time for the frameless group, counting this as time from starting of the surgical procedure to the end of the implantation surgery (Figure 3).
The right side was operated on first; more tracts on the right side were used than
the ones on the left for MER recording (Figure 4).
The number of tracts recorded for the patients who underwent the frameless
procedure was less than that for the patients who underwent the frame-based
procedure. The lengths of STN estimated by MER for the frameless procedures were
longer, though not significantly so, than those recorded for the frame-based
procedures (Figure 5).
DISCUSSION
DBS is now a well-established treatment modality for medically uncontrollable
PD.25 Good clinical results are obtained by precise positioning and implantation of the
electrodes; the locations of the electrodes are calculated and repeatedly tested before
and during the DBS operation.26 Our results showed that the frameless DBS procedure
are small.
The frameless procedure had the following advantages over the frame-based
procedure using the Fisher frame with our set-up: preoperative trajectory planning and
the absence of the restraint head frame, and a shorter operating time. Pre-operative
planning was not practical with the Medtronic Treon system using the Fisher frame,
though it is theoretically possible with other frames, using a “frame free”
pre-operative MRI fused to a CT with the frame in place.
The number of tracts recorded by MER for the patients who underwent the
frameless procedure was less than that for the patients who underwent the
frame-based procedures, though with these numbers not significantly so. Initially, we
performed MER and electrode implantation on the right side. During MER, 2–3 tracts
were recorded for the frame-based procedures, and 1 or 2 tracts were recorded for the
left side in the frameless procedure. The left side MER tracts were judged from the
mirror image of the right side and therefore were lesser in number than the right side
tracts. Although more tracts were used for the frame-based procedures the difference
was not significant.
In this study the neurological status of the patient (such as strength, vision, and improvement of motor function) is monitored frequently during the operation, by the surgeon or by the neurologist, so that the operative time as a baseline is quite long,
though not outrageously so as compared with previous studies.22-24; most results are
described using a standard frame such as Leksell or CRW, both of which can be used with framelink to gain all the advantages of pre-operative planning we consider are generated by the NexFrame, and therefore no difference in operating times are to be expected.
Conclusion
This preliminary work suggests that DBS can be done in a frameless manner
with similar benefits as the frame-based procedure. The operation time for the
frameless procedures was shorter than that for the frame-based procedures. Further
studies are required to compare the efficacy, safety, and long-term clinical outcomes
of the modern frame-based and frameless procedures and for longer time span.
Disclosure
The authors have no personal financial or institutional interest in any of the
drugs, materials, or devices described in this article.
Acknowledgments
This study is supported in part by Taiwan Department of Health Clinical Trial
and Research Center of Excellence (DOH102-TD-B-111-004) and National Science
FIGURE LEGENDS
Figure 1. Levo-dopa dosage intake before and after after operation.
Figure 2. The UPDRS (unified Parkinson’s disease rating scale) before and after DBS operation.
Figure 3. The operation time between frame-based and frameless groups. Figure 4. The left and right side tracts for MER recording.
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