Carolyn, ...
 

as Chasmo, our DBS guru, continually points out, the most important factor in the success of (a viable) DBS is the experience of the surgical team.

Just as note, in the UK, 9.00p.m. BBC1, a DBS procedure is being filmed.

On the original point of DBS, young vs old, I am cynical. DBS is such an invasive procedure, with inherent risk that I cannot imagine why anyone would go for it while the drugs work.

I wonder if Medtronic and private medicine is pushing DBS to get the cash in now, before a less invasive alternative, (perhaps gene therapy) comes along. Remember, Medtronic have invested in Neurologix so they must see some threat/opportunity there.

Aftermathman.

Just because I am paranoid doesn't mean their not out to get us :)

Good points Aftermathman. Funny how the corporate dollar, or should we say the stockholders, seem to dictate current medical protocol. This further complicates the equation. Let's see......?????

Successful DBS = age (+) degree of disabiility(dyskinesia) (+) medical status of patient (-) unavailability of alternative therapies (Stem cell, gene therapy, others, etc) (+ or -) personal experience of others (+) Patients needs(work,etc.) (+) insurance coverage (+) skill of surgical team (-) corporate spread sheet (+) patient's intuition (+) "the real data" (-) unknown factors.

I am thankful for internet forums such as this, where we have the opportunity to discuss these complex topics and issues.

A "gold standard" team these days has a 90%+ success rate, a 1% rate of complications, the other 5-10% basically do not either A. Get any benefit, or B. have unrealistic expectations for their DBS.
Surgeons skill is of paramount importance. There is a small percentage, as outlined above that for some unknown reason do not get any benefit from theirs. It appears to me ,however, a good team can ameliorate that percentage greatly.

Charlie

And those giant pneumatic drills similar to the one used for drilling tunnels under the English chanel are now adorning neuro surgeons arsenal of weaponry. Used for you no what !!! And what are those chainsaws for???:D

GO HARD SCIENCE

N.Z. neurosurgeons
 

Howard, Do you know if there are any neurosurgeons performing DBS in NZ yet?
I ask because I know someone on the south island who is getting less and less on time from meds and markedly dyskinesic when on, no doubt a candidate for DBS.
From a practical and economic point of view for reviewing and changes in neurostimulator settings a DBS team closer to home would be more convenient than coming here (Sydney.)
Many thanks in advance,
Lee

Dr David McCauley
 

of Auckland Hospital is a genius and has many years experience at DBS. He is also my neuro surgeon. I have heard there are excellent neuros in the South Island, tell your friend to check with his neuro in Christchurch.

All the best

GO HARD SCIENCE

Clinical Trial
 

The only reference to early intervention with DBS is this from PDtrials.org and ClinicalTrails.gov

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Official Study Title: Safety and Tolerability of Neurostimulation in Early Stage Parkinson’s Disease
Sponsor: Medtronic
http://www.pdtrials.org/front/trial_...p?trial_id=129


Sumary: Levodopa is commonly used as a treatment for many people who are diagnosed with Parkinson’s disease. Often times these people encounter levodopa-induced motor complications as a result, which can include problems with walking, freezing of gait, and other issues.

B-STN DBS (deep brain stimulation) is one of the most effective surgical treatments for people with PD who suffer from levodopa-induced motor complications. This procedure has a relatively low incidence of permanent adverse effects, as well as the potential for neuroprotection and alteration of the natural course of PD. These results suggest a highly favorable benefit-to-risk ratio of this procedure.

Neuroprotection can be a medication or treatment that aims to slow or stop the progression of PD. Since neuroprotection is best applied early in the disease course when there are more surviving neurons in the brain, the researchers for this study believe that further investigation of this procedure is warranted.

This pilot study is designed to collect the preliminary safety and tolerability data necessary to conduct a future phase III clinical study. The phase III study will investigate the hypothesis that deep brain stimulation of the subthalamic nucleus in the brain of people with early Parkinson’s will slow the progression of the disease. The study will compare the safety and tolerability of B-STN DBS plus optimal drug therapy vs. optimal drug therapy alone (control, standard of care) in 30 people (15 per group) with early PD.

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From Clinical Trials.gov

DBS for Early Stage Parkinson's Disease

This study is currently recruiting patients.
Verified by Vanderbilt University
August 2006
Sponsored by: Vanderbilt University
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00282152

Purpose
B-STN DBS is one of the most effective surgical treatments for PD patients suffering from levodopa-induced motor complications. The relatively low incidence of permanent adverse effects and the potential for neuroprotection and alteration of the natural course of PD suggest a highly favorable benefit-to-risk ratio of this procedure. Since neuroprotection is best applied early in the disease course when there are more surviving neurons, we believe that further investigation of this procedure is warranted. The proposed pilot study will provide the necessary data to substantiate the safety and tolerability of the procedure as well as provide data for the design of a full-scale, multicenter trial to investigate the hypothesis that B-STN DBS is a safe and effective treatment to slow the progression of PD.

Condition: Parkinson's Disease
Intervention: Procedure - Deep Brain Stimulation of STN
Phase: Phase I

MedlinePlus related topics: Parkinson's Disease
Genetics Home Reference related topics: Parkinson disease

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Safety and Tolerability of Neurostimulation in Early Stage Parkinson's Disease

Further study details as provided by Vanderbilt University:

Primary Outcomes: Safety: Time to reach a 20% increase (worsening) in UPDRS Motor score; Efficacy: Reduction in medication after DBS therapy
Expected Total Enrollment: 30

Study start: March 2006; Expected completion: October 2010
Last follow-up: March 2010; Data entry closure: April 2010

This pilot trial is designed specifically to collect the preliminary safety and tolerability data necessary to conduct a future phase III clinical trial to investigate the hypothesis that deep brain stimulation of the subthalamic nucleus in subjects with early Parkinson’s will slow the progression of the disease.

The study design is a prospective, randomized, blinded, single-center trial comparing the safety and tolerability of B-STN DBS + ODT vs. ODT alone (control, standard of care) in 30 subjects (15 per group) with early PD (Hoehn and Yahr stage II when off medication).

Eligibility
Ages Eligible for Study: 50 Years - 75 Years,
Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

• Patients must have a clinical diagnosis of probable idiopathic PD. The diagnosis will be based upon the presence of at least three of four clinical features according to diagnostic utility (Resting Tremor, Bradykinesia, Rigidity, Asymmetric Onset) and an absence of clinical features suggestive of an alternative diagnosis (see exclusion criteria).
• Demonstrated response to dopaminergic therapy. In order to exclude patients with a possible alternative diagnosis, all subjects included in the study must have demonstrated a good response to DA drugs, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based upon the UPDRS motor examination subscore, following the administration of their DA drug(s) during the screening neurological examination.
• Hoehn and Yahr (H&Y) stage II when OFF medication.
• No contraindications to surgery.
• Age between 50 and 75 years old.
• Available for follow-up for four years.
• Informed Consent: The subject understands the risks, benefits, and alternatives to the study procedures and participation in the study.
• MRI within normal range for age.
• Levodopa or dopamine agonist therapy for less than or equal to two years.

Exclusion Criteria:

• Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by features unusual early in the clinical course: Prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset; dementia preceding motor symptoms; supranuclear gaze palsy (other than restriction of upward gaze) or slowing of vertical saccades in the first year; severe, symptomatic dysautonomia unrelated to medications; documentation of a condition known to produce parkinsonism and plausibly connected to the subject’s symptoms (such as suitably located focal brain lesions or neuroleptic use within the past 6 months)
• Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
• Evidence of dementia
• Major psychiatric disorder
• Previous brain operation or injury.
• Active participation in another clinical trial for the treatment of PD.
• Patients who have demand cardiac pacemakers or implantable cardioverter defibrillators (ICD’s).
• Patients who have medical conditions that require repeat MRI scans or diathermy treatments.
• Evidence of existing dyskinesias or motor fluctuations.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00282152

Chandler E Gill
615-936-6586
chandler.e.gill@vanderbilt.edu

Tennessee
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States; Recruiting

Study chairs or principal investigators

P. David Charles, MD, Principal Investigator, Vanderbilt University Department of Neurology [/INDENT]
More Information

Study ID Numbers: 040797; 1363; G050016
Last Updated: August 11, 2006
Record first received: January 23, 2006
ClinicalTrials.gov Identifier: NCT00282152
Health Authority: United States: Food and Drug Administration; United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-11-22