Parkinson's DiseaseNCT01284686
Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops in Parkinson's Disease
A study testing subthalamo-cortical loops stimulation in a one-sided and bipolar way in people with Parkinson's Disease and Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronised and rhythmic. The oscillatory activity prevails at 8-30 Hz in untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels inversely correlates with motor impairment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease, Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops
- What is being tested?
- subthalamo-cortical loops stimulation in a one-sided and bipolar way
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2012to 27 May 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parkinson's disease idiopathique evolving for more than 5 years
- Dopa-Sensibility superior to 50 %
- Electrodes of stimulation implanted in 2 NST at Timone (Pr PERAGUT)
Who cannot join
- Bad tolerance of the condition OFF Dopa and\or OFF stimulation
Trial locations and contacts
1 site in 1 country.
About this study
Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronised and rhythmic. The oscillatory activity prevails at 8-30 Hz in untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels inversely correlates with motor impairment. Moreover, these different levels in BG-cortical loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment following treatment with dopaminergic drugs and is partially suppressed prior to and during voluntary movements. An unanswered question is how do BG-cortical loops become so prominently engaged in this oscillatory activity? One possible explanation is that the resonance frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that oscillations in this band are transmitted particularly well. This hypothesis was confirmed in a previous series of experiments.The aim is to determine whether the resonance frequency within BG-cortical loops is correlated to the BG-cortical coherence frequency (with 20 subjets during 24 months).
Read the detailed description
Methods: Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients at rest and during simple and complex motor tasks while recording the steady state evoked potential over the cortex using EEG. The resonance frequency will be calculated as previously (Eusebio et al, Brain 2009). Experiments will be carried out both in the OFF medication and ON medication condition.
- Conditions
- Parkinson's Disease, Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops
- Being tested
- subthalamo-cortical loops stimulation in a one-sided and bipolar way
- Keywords
- Pathophysiology, Parkinson, neuronal oscillations
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subthalamo-cortical loops stimulation in a one-sided and bipolar wayOther
Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients
subthalamo-cortical loops stimulation in a one-sided and bipolar wayOther
Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients
| Study group | Role | What they receive |
|---|---|---|
| dopamine | Active comparator | ON DOPA:The patient will take his usual treatment with dopamine Receives: Other: subthalamo-cortical loops stimulation in a one-sided and bipolar way |
| without dopa | Experimental | OFF Dopa: The patient will be deprived of his treatment usual dopaminergique for at least 12 hours Receives: Other: subthalamo-cortical loops stimulation in a one-sided and bipolar way |
What is being measured
The primary outcome is the main question the study is designed to answer.
the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD
Measured: 24 months
Secondary outcomes (1)
may provide a basis for different therapeutic strategies
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study start26 Mar 2012
- Primary completion27 May 2015
- Study completion27 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe AZULAY, Principal investigator, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284686
- Sponsor's protocol ID
- 2009-A00913-54
- Status last verified
- Jul 2022
- First submitted
- 26 Jan 2011
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Azulay JP, Witjas T, Eusebio A. Effect of subthalamic deep brain stimulation on non-motor fluctuations in Parkinson's disease. J Neural Transm (Vienna). 2013 Apr;120(4):655-7. doi: 10.1007/s00702-012-0958-9. Epub 2012 Dec 23.
PubMed 23263599
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01284686
- Acronym / sponsor ID
- 2009-A00913-54
- Conditions
- Parkinson's Disease, Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops
- Keywords
- Pathophysiology, Parkinson, neuronal oscillations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 26 Mar 2012 (actual)
- Primary completion
- 27 May 2015 (actual)
- Study completion
- 27 May 2015 (actual)
- First posted
- 27 Jan 2011 (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.
Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronised and rhythmic. The oscillatory activity prevails at 8-30 Hz in untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels inversely correlates with motor impairment. Moreover, these different levels in BG-cortical loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment following treatment with dopaminergic drugs and is partially suppressed prior to and during voluntary movements. An unanswered question is how do BG-cortical loops become so prominently engaged in this oscillatory activity? One possible explanation is that the resonance frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that oscillations in this band are transmitted particularly well. This hypothesis was confirmed in a previous series of experiments.The aim is to determine whether the resonance frequency within BG-cortical loops is correlated to the BG-cortical coherence frequency (with 20 subjets during 24 months).
Detailed description
Methods: Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients at rest and during simple and complex motor tasks while recording the steady state evoked potential over the cortex using EEG. The resonance frequency will be calculated as previously (Eusebio et al, Brain 2009). Experiments will be carried out both in the OFF medication and ON medication condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dopamine | Active comparator | Other: subthalamo-cortical loops stimulation in a one-sided and bipolar wayON DOPA:The patient will take his usual treatment with dopamine |
| without dopa | Experimental | Other: subthalamo-cortical loops stimulation in a one-sided and bipolar wayOFF Dopa: The patient will be deprived of his treatment usual dopaminergique for at least 12 hours |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's disease idiopathique evolving for more than 5 years
- Dopa-Sensibility superior to 50 %
- Electrodes of stimulation implanted in 2 NST at Timone (Pr PERAGUT)
Key exclusion criteria (1 listed)
- Bad tolerance of the condition OFF Dopa and\or OFF stimulation
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 |
|---|---|---|
| subthalamo-cortical loops stimulation in a one-sided and bipolar wayRecord STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients | Other | dopamine |
| subthalamo-cortical loops stimulation in a one-sided and bipolar wayRecord STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients | Other | without dopa |
Primary outcome
the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD
Time frame: 24 months
1 secondary outcome
may provide a basis for different therapeutic strategies
Time frame: 24 months
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 7 May 2026.
- Results publication: PubMed 23263599Azulay JP, Witjas T, Eusebio A. Effect of subthalamic deep brain stimulation on non-motor fluctuations in Parkinson's disease. J Neural Transm (Vienna). 2013 Apr;120(4):655-7. doi: 10.1007/s00702-012-0958-9. Epub 2012 Dec 23.
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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.
Jean-Philippe AZULAY principal investigator
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subthalamo-cortical loops stimulation in a one-sided and bipolar way in people with Parkinson's Disease and Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops, run by Assistance Publique Hopitaux De Marseille 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 3 inclusion and 1 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 7 May 2026. 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 understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD (time frame: 24 months). 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 NCT01284686, which also lists 1 linked publication.
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 7 May 2026.