Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops in Parkinson's Disease
1 other identifier
interventional
23
1 country
1
Brief 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. 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).
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 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2011
CompletedFirst Posted
Study publicly available on registry
January 27, 2011
CompletedStudy Start
First participant enrolled
March 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2015
CompletedMay 7, 2026
July 1, 2022
3.2 years
January 26, 2011
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD
24 months
Secondary Outcomes (1)
may provide a basis for different therapeutic strategies
24 months
Study Arms (2)
dopamine
ACTIVE COMPARATORON DOPA:The patient will take his usual treatment with dopamine
without dopa
EXPERIMENTALOFF Dopa: The patient will be deprived of his treatment usual dopaminergique for at least 12 hours
Interventions
Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Bad tolerance of the condition OFF Dopa and\\or OFF stimulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
APHM
Marseille, 13, France
Related Publications (1)
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.
PMID: 23263599RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Philippe AZULAY
APHM
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2011
First Posted
January 27, 2011
Study Start
March 26, 2012
Primary Completion
May 27, 2015
Study Completion
May 27, 2015
Last Updated
May 7, 2026
Record last verified: 2022-07