Sub-thalamic Nucleus Stimulation in Parkinson Disease
PARKEO
1 other identifier
interventional
30
1 country
1
Brief Summary
Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of Parkinson's disease. This procedure performed in two steps using electrophysiology. This study is a prospective, randomized and monocentric study to compare two DBS procedures with or without electrophysiology. A better control of targeting and trajectory is necessary before not using electrophysiology, which is the reference procedure. A new definition of sub thalamic nuclei with new MRI stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the use of operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic nuclei without the need of electrophysiology. Two groups of patients will be followed: a first group of patients with a procedure under general anesthesia alone without electrophysiological stimulation and a second smaller group of patients with a first step of electrode implantation under awake surgery with electrophysiological stimulation followed by a second step under general anesthesia for the implantation of stimulator. Clinical results will be assessed at 6 months after implantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2013
CompletedFirst Submitted
Initial submission to the registry
March 20, 2013
CompletedFirst Posted
Study publicly available on registry
March 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2016
CompletedAugust 24, 2017
August 1, 2017
3.5 years
March 20, 2013
August 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the ratio of preoperative and postoperative UPDRS 3 score
The primary outcome is defined after six months of sub-thalamic nucleus deep brain stimulation with the ratio of preoperative and postoperative UPDRS 3 score. The ratio is : (post operative UPDRS 3 OFF medicine and OFF stimulation- post operative UPDRS 3 OFF medicine ON stimulation)/(post operative UPDRS 3 OFF medicine OFF stimulation)
6 month
Secondary Outcomes (16)
Stimulation efficacy
6 month
The variance of improvement mean for the "high precision" technique
6 month
Percentage of patients with an improvement of UPDRS III score
6 month
The Calculated preoperative and post operative (6 months) equivalent dose of L-DOPA and the decrease of between preoperative and post operative period (6 months).
6 month
Percentage of patients with failure of the new surgical technique defined with an improvement of less than 35 % with the UPDRS 3 score and an electrode located more than 4 mm from the target
6 month
- +11 more secondary outcomes
Study Arms (2)
New targeting procedure without electrophysiology
EXPERIMENTALPatients with the high precision procedure under general anesthesia alone without electrophysiological stimulation
Classical neurosurgical procedure
ACTIVE COMPARATORpatients with a first step of electrode implantation under awake surgery with electrophysiological control followed by a second step under general anesthesia
Interventions
It is a neurosurgical procedure of electrodes implantation in the sub thalamic nuclei under general anaesthesia using a new targeting procedure without electrophysiology.
It is a neurosurgical procedure of electrodes implantation in the sub thalamic nuclei under awake surgery with electrophysiological control. A second surgical step is performed to implant the subcutaneous stimulation device, under general anesthesia.
Eligibility Criteria
You may qualify if:
- Age : between 18 and 70 years old
- Parkinson disease in fluctuation state despite the use of an optimal medical treatment
- Dopa sensibility higher than 50% with the L-DOPA test
- Normal MRI
- Mattis Scale \> 130
- Surgical indication approved by a multidisciplinary team
- Patient covered by a social insurance
- Informed consent signed by patient and investigator
You may not qualify if:
- Patients with surgical or anesthetic contraindications
- Cerebral atrophy or signal abnormalities on MRI
- Severe Depressive State : The Beck Scale score \> 15
- Women of childbearing potential without efficient contraceptive mean
- Need of long-term antithrombotic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Bordeaux, 33076, France
Related Publications (8)
Bronstein JM, Tagliati M, Alterman RL, Lozano AM, Volkmann J, Stefani A, Horak FB, Okun MS, Foote KD, Krack P, Pahwa R, Henderson JM, Hariz MI, Bakay RA, Rezai A, Marks WJ Jr, Moro E, Vitek JL, Weaver FM, Gross RE, DeLong MR. Deep brain stimulation for Parkinson disease: an expert consensus and review of key issues. Arch Neurol. 2011 Feb;68(2):165. doi: 10.1001/archneurol.2010.260. Epub 2010 Oct 11.
PMID: 20937936BACKGROUNDCuny E, Guehl D, Burbaud P, Gross C, Dousset V, Rougier A. Lack of agreement between direct magnetic resonance imaging and statistical determination of a subthalamic target: the role of electrophysiological guidance. J Neurosurg. 2002 Sep;97(3):591-7. doi: 10.3171/jns.2002.97.3.0591.
PMID: 12296643BACKGROUNDFerrara J, Diamond A, Hunter C, Davidson A, Almaguer M, Jankovic J. Impact of STN-DBS on life and health satisfaction in patients with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010 Mar;81(3):315-9. doi: 10.1136/jnnp.2009.184127. Epub 2009 Sep 1.
PMID: 19726415BACKGROUNDKenney C, Simpson R, Hunter C, Ondo W, Almaguer M, Davidson A, Jankovic J. Short-term and long-term safety of deep brain stimulation in the treatment of movement disorders. J Neurosurg. 2007 Apr;106(4):621-5. doi: 10.3171/jns.2007.106.4.621.
PMID: 17432713BACKGROUNDKleiner-Fisman G, Herzog J, Fisman DN, Tamma F, Lyons KE, Pahwa R, Lang AE, Deuschl G. Subthalamic nucleus deep brain stimulation: summary and meta-analysis of outcomes. Mov Disord. 2006 Jun;21 Suppl 14:S290-304. doi: 10.1002/mds.20962.
PMID: 16892449BACKGROUNDLimousin P, Krack P, Pollak P, Benazzouz A, Ardouin C, Hoffmann D, Benabid AL. Electrical stimulation of the subthalamic nucleus in advanced Parkinson's disease. N Engl J Med. 1998 Oct 15;339(16):1105-11. doi: 10.1056/NEJM199810153391603.
PMID: 9770557BACKGROUNDMaltete D, Navarro S, Welter ML, Roche S, Bonnet AM, Houeto JL, Mesnage V, Pidoux B, Dormont D, Cornu P, Agid Y. Subthalamic stimulation in Parkinson disease: with or without anesthesia? Arch Neurol. 2004 Mar;61(3):390-2. doi: 10.1001/archneur.61.3.390.
PMID: 15023817BACKGROUNDEngelhardt J, Caire F, Damon-Perriere N, Guehl D, Branchard O, Auzou N, Tison F, Meissner WG, Krim E, Bannier S, Benard A, Sitta R, Fontaine D, Hoarau X, Burbaud P, Cuny E. A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease. Stereotact Funct Neurosurg. 2021;99(3):230-240. doi: 10.1159/000511424. Epub 2020 Nov 30.
PMID: 33254172DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuel CUNY, MD-PhD
University Hospital Bordeaux, France
- STUDY CHAIR
Antoine BENARD, MD
University Hospital Bordeaux, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2013
First Posted
March 22, 2013
Study Start
March 11, 2013
Primary Completion
September 9, 2016
Study Completion
September 9, 2016
Last Updated
August 24, 2017
Record last verified: 2017-08