Parkinson DiseasePARKEO2NCT04884412
Deep Brain Stimulation for Parkinson's Disease: Probabilistic STN Targeting Under General Anaesthesia Without Micro-electrode Recordings vs Current Targeting Procedure
A study testing Surgery under general anesthesia with experimental targeting and Usual Surgery in people with Parkinson Disease, run by University Hospital, Bordeaux at 8 sites in France.
Trial summary
Deep brain stimulation (DBS) of the sub-thalamic nucleus (STN) has evolved over the past decades as a mainstream therapy for advanced Parkinson's disease (PD). The classical procedure consists in STN indirect targeting based on stereotactic atlases or statistical coordinates in AC-PC (Anterior Commissure - Posterior… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Surgery under general anesthesia with experimental targeting and Usual Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 8 sitesFrance
- Study dates
- 10 Nov 2021to 18 Nov 2025
- 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
- Patients with a diagnosis of idiopathic Parkinson's disease at the stage of motor fluctuations despite optimal medical treatment
- L-DOPA sensitivity defined by motor improvement above 50% on the UPDRS-3 scale after a dose of 150% of the usual early morning treatment
- Indication for STN-DBS approved by the local multidisciplinary movement disorders committee.
- Patients between 18 and 70 years of age
- Patients covered by a health insurance scheme
- Signed informed consent.
Who cannot join
- Significant cognitive decline defined as a score < 22 on the MoCA scale
- Mood disorders defined by a score > 20 on the Beck Depression Inventory
- Significant cortical atrophy or leukoencephalopathy visualised by brain MRI
- Contraindication to anaesthesia and MRI
- Lack of contraceptive treatment for women with ability to procreate
- Pregnant or breast-feeding woman
Show all 10Show fewer
- Unstoppable anticoagulant or antiaggregant treatment
- Persons under legal protection (Persons deprived of liberty or incapable of giving consent or under curatorship or tutorship…)
- Patient with severe psychiatric disorders (on Diagnostic and Statistical Manual of Mental Disorders IV)
- Inability to follow the patient until the end of study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU Amiens
Amiens
CHU de Bordeaux
Bordeaux
Hospices Civils de Lyon
Lyon
CHU Marseille
Marseille, 13005
CHU de Nice
Nice
CHU de Rouen
Rouen
CHU de Strasbourg
Strasbourg
CHU de Toulouse
Toulouse
About this study
Official title: Deep Brain Stimulation for Parkinson's Disease: Probabilistic STN Targeting Under General Anaesthesia Without Micro-electrode Recordings (MER) vs Current Targeting Procedure
Deep brain stimulation (DBS) of the sub-thalamic nucleus (STN) has evolved over the past decades as a mainstream therapy for advanced Parkinson's disease (PD). The classical procedure consists in STN indirect targeting based on stereotactic atlases or statistical coordinates in AC-PC (Anterior Commissure - Posterior Commissure) referential along with target control and correction by micro-electrode recordings (MER) and awake clinical testing. To avoid potential complications and patient discomfort related to current procedure, asleep surgery without this control process has become more and more performed, essentially thanks to the progress of neuroimaging allowing to STN visualization. However, it has been reported a relative inaccuracy between the "radiological" STN delimitated on several types of MRI sequences (T2, T2*, SWI) and the per-operative electrophysiological findings. As a result, there are currently many types of STN-DBS procedures, and the lack of standardization between techniques complicates the interpretation of postoperative results on anatomical, electrophysiological and clinical points of view. Furthermore, to date, it has not been proven that asleep surgery without MER and clinical controls is as effective as the standard procedure in a prospective controlled randomized clinical trial.
Investigators hypothesize that the clinical-based 18 landmarks STN target will be precise enough to allow to perform surgery under general anesthesia without MER correction, and accurate enough to achieve non inferior clinical results compared to what is usually done in each centre.
The main objective is to compare at one year, the % of motor improvement after PARKEO 2-targeting asleep DBS without intraoperative MER versus the targeting procedure using intraoperative MER by the UPRDRS 3 (Unified Parkinson's disease rating scale 3).
- Conditions
- Parkinson Disease
- Being tested
- Surgery under general anesthesia with experimental targeting, Usual Surgery
- Keywords
- Deep brain stimulation, Sub-thalamic nucleus, Parkinson Disease, Micro-electrode recordings, DBS targeting
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery under general anesthesia with experimental targetingProcedure or surgery
Surgery will be performed under general anesthesia. The electrodes will be inserted directly on the targets without MER, with PARKEO_2 targets provided by the Bordeaux University Hospital, based on the machine-learning model developed in Bordeaux.
Usual SurgeryProcedure or surgery
In the control group, surgery will be performed as usual in each centre under local or general anaesthesia. This group represents the current state of the art of deep brain stimulation in these centres.
| Study group | Role | What they receive |
|---|---|---|
| PARKEO 2 targeting with asleep deep brain stimulation procedure | Experimental | Participant with parkeo 2 targeting procedure Receives: Procedure: Surgery under general anesthesia with experimental targeting |
| Usual DBS procedure | Active comparator | Participant with usual targeting and surgery Receives: Procedure: Usual Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulation efficacy
The primary endpoint is the efficacy of the stimulation on motor symptoms assessed by the change in UPDRS-3 scores between OFF and ON stimulation evaluations at one year after surgery without any medical treatment (OFF medication).
Unified Parkinson's Disease Rating Scale 3 (UPDRS 3) questionnaire: 0 to 132 points, with the highest score indicating worsening
Measured: 12 months after surgery (M12)
Secondary outcomes (16)
Quality of life assessment
Quality of life on the Parkinson Disease Questionnaire 39 (PDQ39) scale assessed by the change in PDQ39 scores.
PDQ 39 questionnaire : 0 to 156 points, with the highest score indicating worsening condition
Measured: inclusion (Month-1) and 12 months after surgery (M12)
Stereotactic accuracy
Stereotactic accuracy as measured by the Euclidian distance between active contact location and intra-operative defined target in each group
Measured: Surgery intervention (Month 0)
Operative characteristics (1)
Operative characteristic : procedure length
Measured: Surgery intervention (Month 0)
Operative characteristics (2)
Operative characteristic : radiation dose
Measured: Surgery intervention (Month 0)
Operative characteristics (3)
Operative characteristic : pneumocephalus
Measured: Surgery intervention (Month 0)
Operative characteristics (4)
Operative characteristic : and length of hospital stay (in days).
Measured: Surgery intervention (Month 0)
Distance between active contact location and preoperative target
Distance between active contact location and preoperative defined target in each group
Measured: Surgery intervention (Month 0)
Improvement of UPDRS3
The percentage of improvement of UPDRS3 calculated between the preoperative OFF and the post-operative ON stimulation scores at one year and compared between the two groups.
Unified Parkinson's Disease Rating Scale 3 (UPDRS 3) questionnaire: 0 to 132 points, with the highest score indicating worsening
Measured: 12 months after surgery (M12)
Efficacy of the targeting procedure on motor symptoms (1)
The efficacy of the targeting procedure on motor symptoms assessed by the change in UPDRS-3 scores between OFF and ON stimulation evaluations at one year after surgery without any medical treatment (OFF medication). The change will be calculated as a difference between the OFF and ON stimulation scores at one year.
Unified Parkinson's Disease Rating Scale 3 (UPDRS 3) questionnaire: 0 to 132 points, with the highest score indicating worsening
Measured: 12 months after surgery (M12)
Efficacy of the targeting procedure on motor symptoms (2)
The efficacy of the targeting procedure on motor symptoms compared to the efficacy of L-DOPA by the change in UPDRS-3 scores between OFF and ON stimulation evaluations at one year after surgery without any medical treatment (OFF medication). The change will be calculated as a ratio between the effect of stimulation alone versus medication alone at one year.
Unified Parkinson's Disease Rating Scale 3 (UPDRS 3) questionnaire: 0 to 132 points, with the highest score indicating worsening
Measured: 12 months after surgery (M12)
reduction in the levodopa equivalent daily doses (LEDD)
The reduction in the levodopa equivalent daily doses (LEDD) from the baseline and one year (a 100-mg daily dose of standard levodopa is equivalent to the following doses of other medications: 133 mg of controlled-release levodopa; 75 mg of levodopa plus entacapone; 1 mg of pergolide, pramipexole lisuride, or cabergoline; 5 mg of ropinirole; 10 mg of bromocriptine or apomorphine; and 20 mg of dihydroergocryptine) will be evaluated
Measured: 12 months after surgery (M12)
Post-operative cognitive
Post-operative cognitive will be assess by the difference from the baseline and one year using MDRS.
Mattis Dementia Rating Scale: 0 to 144 points, with the most important score indicating improvement in condition
Measured: 12 months after surgery (M12)
Post-operative mood
Post-operative mood will be assess by the difference from the baseline and one year using BDI scale.
Beck Depression Inventory (BDI): 0 to 63 points, with the most important score indicating worsening condition
Measured: 12 months after surgery (M12)
Intra and post-operative surgical complications
Intra and post-operative surgical complications (haemorrhage, infection, neuromodulation-related side effects) will be prospectively collected and assessed
Measured: Surgery intervention (Month 0)
Total cost of each procedure (PARKEO-2 targeting compared to targeting procedure using intraoperative MER)
A cost analysis will be performed to assess all hospital resources
Measured: Surgery intervention (Month 0)
Cost-effectiveness ratio, expressed in terms of cost per Qaly gained at 1 year
This ratio will provide useful information about the costs (avoided or additional) required to gain a Qaly, one year after surgery, from the French healthcare system point of view
Measured: 12 months after surgery (M12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start10 Nov 2021
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National multicentre, prospective, randomised, non-inferiority, open label, comparative clinical trial in 2 parallel groups.
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien ENGELHARDT, Dr, Principal investigator, University Hospital, BordeauxEmmanuel CUNY, Pr, Study director, University Hospital, BordeauxAntoine BENARD, Dr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884412
- Sponsor's protocol ID
- CHUBX 2019/54
- Acronym
- PARKEO2
- Status last verified
- Dec 2025
- First submitted
- 27 Apr 2021
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation for Parkinson's Disease: Probabilistic STN Targeting Under General Anaesthesia Without Micro-electrode Recordings (MER) vs Current Targeting Procedure
- ClinicalTrials.gov ID
- NCT04884412
- Acronym / sponsor ID
- PARKEO2 / CHUBX 2019/54
- Conditions
- Parkinson Disease
- Keywords
- Deep brain stimulation, Sub-thalamic nucleus, Parkinson Disease, Micro-electrode recordings, DBS targeting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 13 May 2021 (actual)
- 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) of the sub-thalamic nucleus (STN) has evolved over the past decades as a mainstream therapy for advanced Parkinson's disease (PD). The classical procedure consists in STN indirect targeting based on stereotactic atlases or statistical coordinates in AC-PC (Anterior Commissure - Posterior Commissure) referential along with target control and correction by micro-electrode recordings (MER) and awake clinical testing. To avoid potential complications and patient discomfort related to current procedure, asleep surgery without this control process has become more and more performed, essentially thanks to the progress of neuroimaging allowing to STN visualization. However, it has been reported a relative inaccuracy between the "radiological" STN delimitated on several types of MRI sequences (T2, T2*, SWI) and the per-operative electrophysiological findings. As a result, there are currently many types of STN-DBS procedures, and the lack of standardization between techniques complicates the interpretation of postoperative results on anatomical, electrophysiological and clinical points of view. Furthermore, to date, it has not been proven that asleep surgery without MER and clinical controls is as effective as the standard procedure in a prospective controlled randomized clinical trial.
Investigators hypothesize that the clinical-based 18 landmarks STN target will be precise enough to allow to perform surgery under general anesthesia without MER correction, and accurate enough to achieve non inferior clinical results compared to what is usually done in each centre.
The main objective is to compare at one year, the % of motor improvement after PARKEO 2-targeting asleep DBS without intraoperative MER versus the targeting procedure using intraoperative MER by the UPRDRS 3 (Unified Parkinson's disease rating scale 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- National multicentre, prospective, randomised, non-inferiority, open label, comparative clinical trial in 2 parallel groups.
| Arm | Type | Receives |
|---|---|---|
| PARKEO 2 targeting with asleep deep brain stimulation procedure | Experimental | Procedure: Surgery under general anesthesia with experimental targetingParticipant with parkeo 2 targeting procedure |
| Usual DBS procedure | Active comparator | Procedure: Usual SurgeryParticipant with usual targeting and surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a diagnosis of idiopathic Parkinson's disease at the stage of motor fluctuations despite optimal medical treatment
- L-DOPA sensitivity defined by motor improvement above 50% on the UPDRS-3 scale after a dose of 150% of the usual early morning treatment
- Indication for STN-DBS approved by the local multidisciplinary movement disorders committee.
- Patients between 18 and 70 years of age
- Patients covered by a health insurance scheme
Key exclusion criteria (10 listed)
- Significant cognitive decline defined as a score < 22 on the MoCA scale
- Mood disorders defined by a score > 20 on the Beck Depression Inventory
- Significant cortical atrophy or leukoencephalopathy visualised by brain MRI
- Contraindication to anaesthesia and MRI
- Lack of contraceptive treatment for women with ability to procreate
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 |
|---|---|---|
| Surgery under general anesthesia with experimental targetingSurgery will be performed under general anesthesia. The electrodes will be inserted directly on the targets without MER, with PARKEO_2 targets provided by the Bordeaux University Hospital, based on the machine-learning model developed in Bordeaux. | Procedure or surgery | PARKEO 2 targeting with asleep deep brain stimulation procedure |
| Usual SurgeryIn the control group, surgery will be performed as usual in each centre under local or general anaesthesia. This group represents the current state of the art of deep brain stimulation in these centres. | Procedure or surgery | Usual DBS procedure |
Primary outcome
Stimulation efficacy
Time frame: 12 months after surgery (M12)
The primary endpoint is the efficacy of the stimulation on motor symptoms assessed by the change in UPDRS-3 scores between OFF and ON stimulation evaluations at one year after surgery without any medical treatment (OFF medication). Unified Parkinson's Disease Rating Scale 3 (UPDRS 3) questionnaire: 0 to 132 points, with the highest score indicating worsening
16 secondary outcomes
Quality of life assessment
Time frame: inclusion (Month-1) and 12 months after surgery (M12)
Stereotactic accuracy
Time frame: Surgery intervention (Month 0)
Operative characteristics (1)
Time frame: Surgery intervention (Month 0)
Operative characteristics (2)
Time frame: Surgery intervention (Month 0)
Operative characteristics (3)
Time frame: Surgery intervention (Month 0)
Operative characteristics (4)
Time frame: Surgery intervention (Month 0)
Distance between active contact location and preoperative target
Time frame: Surgery intervention (Month 0)
Improvement of UPDRS3
Time frame: 12 months after surgery (M12)
Efficacy of the targeting procedure on motor symptoms (1)
Time frame: 12 months after surgery (M12)
Efficacy of the targeting procedure on motor symptoms (2)
Time frame: 12 months after surgery (M12)
reduction in the levodopa equivalent daily doses (LEDD)
Time frame: 12 months after surgery (M12)
Post-operative cognitive
Time frame: 12 months after surgery (M12)
Post-operative mood
Time frame: 12 months after surgery (M12)
Intra and post-operative surgical complications
Time frame: Surgery intervention (Month 0)
Total cost of each procedure (PARKEO-2 targeting compared to targeting procedure using intraoperative MER)
Time frame: Surgery intervention (Month 0)
Cost-effectiveness ratio, expressed in terms of cost per Qaly gained at 1 year
Time frame: 12 months after surgery (M12)
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 15 Dec 2025.
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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.
Julien ENGELHARDT, Dr principal investigator
University Hospital, Bordeaux
Emmanuel CUNY, Pr study director
University Hospital, Bordeaux
Antoine BENARD, Dr study chair
University Hospital, Bordeaux
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery under general anesthesia with experimental targeting and Usual Surgery in people with Parkinson Disease, run by University Hospital, Bordeaux at 8 sites 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 6 inclusion and 10 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Stimulation efficacy (time frame: 12 months after surgery (M12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2025.