Parkinson's DiseasePARKEONCT01817088
Sub-thalamic Nucleus Stimulation in Parkinson Disease
A study testing New targeting procedure without electrophysiology and Classical neurosurgical procedure in people with Parkinson's Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- New targeting procedure without electrophysiology and Classical neurosurgical procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2013to 9 Sep 2016
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sub-thalamic Nucleus Stimulation in Parkinson Disease: Comparison of a Two-steps Electrophysiological Approach Under Local and General Anesthesia and a One-step Approach Under General Anesthesia
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.
Read more
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.
Read the detailed description
Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of Parkinson's disease. This procedure performed in two steps using electrophysiology (Limousin et al., 1995) to register the activity of the sub-thalamic nucleus and test the efficacy of stimulation while the patient is awake. A second procedure is needed a few days later to implant the stimulation device under general anaesthesia. The duration of the first procedure is long because of a necessary time of deep stimulation to control the target before definitive implantation. Firstly, the long time of procedure causes pain for the patient. Secondly, the time of procedure, and thus of electrophysiology, is correlated with a rate of device infection of 5 % - 6 % (Hamani et al., 2006; Kenney et al., 2007; Sillay et al., 2008; Doshi et al., 2011). Thirdly, the introduction of several microelectrodes increases the risk of operative and postoperative haemorrhages, estimated at 1 % (Kenney et al., 2007; Sansur et al., 2007; Voges et al., 2007; Bhatia et al., 2008). Moreover, Foltynie et al. (2011) described 12/79 patients treated under general anaesthesia alone with the same post operative results than those who were firstly treated under local anaesthesia.
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. (Caire et al. 2012, In press).
This study is a prospective, randomized and monocentric study. The randomization will be made according to a ratio 2:1 in favour of the technique without 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.
After a preoperative assessment, a end-point evaluation at 6 months after implantation will complete the follow-up.
The stimulation efficacy (UPDRS-3) and the post operative adverse effects will be noticed.
This study will also evaluate the occurrence of a post-traumatic stress disorder (PTSD) in Parkinson disease patients operated under deep brain stimulation.
- Conditions
- Parkinson's Disease
- Being tested
- New targeting procedure without electrophysiology, Classical neurosurgical procedure
- Keywords
- Deep Brain Stimulation (DBS), Parkinson disease, Stereotaxis Technique, Subthalamic nucleus
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New targeting procedure without electrophysiologyProcedure or surgery
It is a neurosurgical procedure of electrodes implantation in the sub thalamic nuclei under general anaesthesia using a new targeting procedure without electrophysiology.
Classical neurosurgical procedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| New targeting procedure without electrophysiology | Experimental | Patients with the high precision procedure under general anesthesia alone without electrophysiological stimulation Receives: Procedure: New targeting procedure without electrophysiology |
| Classical neurosurgical procedure | Active comparator | patients with a first step of electrode implantation under awake surgery with electrophysiological control followed by a second step under general anesthesia Receives: Procedure: Classical neurosurgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 month
Secondary outcomes (16)
Stimulation efficacy
Efficacy with the ratio : (Preoperative UPDRS 3 OFF medicine - post operative UPDRS 3 OFF medicine ON stimulation)/( preoperative UPDRS 3 OFF medicine )
Measured: 6 month
The variance of improvement mean for the "high precision" technique
The variance of improvement mean for the "high precision" technique
Measured: 6 month
Percentage of patients with an improvement of UPDRS III score
Percentage of patients with an improvement of UPDRS III score of 35%, 50% et 65%
Measured: 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).
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).
Measured: 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
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
Measured: 6 month
Quality of Life
Quality of Life scale : PDQ-39
Measured: 6 month
Non motor items of UPDRS score in the high precision technique under general anesthesia alone
Non motor items of UPDRS score in the high precision technique under general anesthesia alone
Measured: 6 month
Adverse effects and complications
Adverse effects and complications : infection, haemorrhages, paresthesia, hypophonia and dyskinesia
Measured: 6 month
Percentage of improvement in patients with the reference technique
Percentage of improvement in patients with the reference technique (electrophysiological approach in awake surgery)
Measured: 6 month
Compare the technical feasibility for both surgeries based on the number of electrodes implanted in the target
Compare the technical feasibility for both surgeries based on the number of electrodes implanted in the target
Measured: after surgery
Operative and postoperative surgical adverse effects.
Operative and postoperative surgical adverse effects.
Measured: 6 month
Evaluate the influence of two operative procedures on the onset and maintenance of post-operative PTSD
Evaluate the influence of two operative procedures on the onset and maintenance of post-operative PTSD
Measured: 6 month
Evaluate the influence of two operative procedures on the level of preoperative anxiety and the time course of this anxiety
Evaluate the influence of two operative procedures on the level of preoperative anxiety and the time course of this anxiety
Measured: 1, 3 and 6 month
Differentiate thymic and cognitive factors potentially predictors of the occurrence of post-surgical PTSD
Differentiate thymic and cognitive factors potentially predictors of the occurrence of post-surgical PTSD
Measured: 6 month
Evaluate the long-term effects of the two operating procedures on thymic and cognitive state
Evaluate the long-term effects of the two operating procedures on thymic and cognitive state
Measured: 6 month
Evaluate the dose of irradiation received by patients during surgery in both procedures
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study start11 Mar 2013
- Primary completion9 Sep 2016
- Study completion9 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel CUNY, MD-PhD, Principal investigator, University Hospital Bordeaux, FranceAntoine BENARD, MD, Study chair, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817088
- Sponsor's protocol ID
- CHUBX 2012/07
- Acronym
- PARKEO
- Status last verified
- Aug 2017
- First submitted
- 20 Mar 2013
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20937936Cuny 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.
PubMed 12296643Ferrara 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.
PubMed 19726415Kenney 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.
PubMed 17432713Kleiner-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.
PubMed 16892449Limousin 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.
PubMed 9770557Maltete 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.
PubMed 15023817Engelhardt 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.
PubMed 33254172
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-thalamic Nucleus Stimulation in Parkinson Disease: Comparison of a Two-steps Electrophysiological Approach Under Local and General Anesthesia and a One-step Approach Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01817088
- Acronym / sponsor ID
- PARKEO / CHUBX 2012/07
- Conditions
- Parkinson's Disease
- Keywords
- Deep Brain Stimulation (DBS), Parkinson disease, Stereotaxis Technique, Subthalamic nucleus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 11 Mar 2013 (actual)
- Primary completion
- 9 Sep 2016 (actual)
- Study completion
- 9 Sep 2016 (actual)
- First posted
- 22 Mar 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.
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.
Detailed description
Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of Parkinson's disease. This procedure performed in two steps using electrophysiology (Limousin et al., 1995) to register the activity of the sub-thalamic nucleus and test the efficacy of stimulation while the patient is awake. A second procedure is needed a few days later to implant the stimulation device under general anaesthesia. The duration of the first procedure is long because of a necessary time of deep stimulation to control the target before definitive implantation. Firstly, the long time of procedure causes pain for the patient. Secondly, the time of procedure, and thus of electrophysiology, is correlated with a rate of device infection of 5 % - 6 % (Hamani et al., 2006; Kenney et al., 2007; Sillay et al., 2008; Doshi et al., 2011). Thirdly, the introduction of several microelectrodes increases the risk of operative and postoperative haemorrhages, estimated at 1 % (Kenney et al., 2007; Sansur et al., 2007; Voges et al., 2007; Bhatia et al., 2008). Moreover, Foltynie et al. (2011) described 12/79 patients treated under general anaesthesia alone with the same post operative results than those who were firstly treated under local anaesthesia.
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. (Caire et al. 2012, In press).
This study is a prospective, randomized and monocentric study. The randomization will be made according to a ratio 2:1 in favour of the technique without 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.
After a preoperative assessment, a end-point evaluation at 6 months after implantation will complete the follow-up.
The stimulation efficacy (UPDRS-3) and the post operative adverse effects will be noticed.
This study will also evaluate the occurrence of a post-traumatic stress disorder (PTSD) in Parkinson disease patients operated under deep brain stimulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New targeting procedure without electrophysiology | Experimental | Procedure: New targeting procedure without electrophysiologyPatients with the high precision procedure under general anesthesia alone without electrophysiological stimulation |
| Classical neurosurgical procedure | Active comparator | Procedure: Classical neurosurgical procedurepatients with a first step of electrode implantation under awake surgery with electrophysiological control followed by a second step under general anesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New targeting procedure without electrophysiologyIt is a neurosurgical procedure of electrodes implantation in the sub thalamic nuclei under general anaesthesia using a new targeting procedure without electrophysiology. | Procedure or surgery | New targeting procedure without electrophysiology |
| Classical neurosurgical procedureIt 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. | Procedure or surgery | Classical neurosurgical procedure |
Primary outcome
the ratio of preoperative and postoperative UPDRS 3 score
Time frame: 6 month
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)
16 secondary outcomes
Stimulation efficacy
Time frame: 6 month
The variance of improvement mean for the "high precision" technique
Time frame: 6 month
Percentage of patients with an improvement of UPDRS III score
Time frame: 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).
Time frame: 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
Time frame: 6 month
Quality of Life
Time frame: 6 month
Non motor items of UPDRS score in the high precision technique under general anesthesia alone
Time frame: 6 month
Adverse effects and complications
Time frame: 6 month
Percentage of improvement in patients with the reference technique
Time frame: 6 month
Compare the technical feasibility for both surgeries based on the number of electrodes implanted in the target
Time frame: after surgery
Operative and postoperative surgical adverse effects.
Time frame: 6 month
Evaluate the influence of two operative procedures on the onset and maintenance of post-operative PTSD
Time frame: 6 month
Evaluate the influence of two operative procedures on the level of preoperative anxiety and the time course of this anxiety
Time frame: 1, 3 and 6 month
Differentiate thymic and cognitive factors potentially predictors of the occurrence of post-surgical PTSD
Time frame: 6 month
Evaluate the long-term effects of the two operating procedures on thymic and cognitive state
Time frame: 6 month
Evaluate the dose of irradiation received by patients during surgery in both procedures
Time frame: During surgery
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 24 Aug 2017.
- Background: PubMed 20937936Bronstein 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.
- Background: PubMed 12296643Cuny 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.
- Background: PubMed 19726415Ferrara 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.
- Background: PubMed 17432713Kenney 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.
- Background: PubMed 16892449Kleiner-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.
- Background: PubMed 9770557Limousin 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.
- Background: PubMed 15023817Maltete 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.
- Derived from this study: PubMed 33254172Engelhardt 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.
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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.
Emmanuel CUNY, MD-PhD principal investigator
University Hospital Bordeaux, France
Antoine BENARD, MD study chair
University Hospital Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New targeting procedure without electrophysiology and Classical neurosurgical procedure in people with Parkinson's Disease, run by University Hospital, Bordeaux at 1 site in France.
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 8 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 24 Aug 2017. 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 France. 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?
the ratio of preoperative and postoperative UPDRS 3 score (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01817088, which also lists 8 linked publications.
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 24 Aug 2017.