Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops in Parkinson's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01284686
First received: January 26, 2011
Last updated: August 28, 2014
Last verified: August 2014

January 26, 2011
August 28, 2014
September 2010
March 2014   (final data collection date for primary outcome measure)
the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01284686 on ClinicalTrials.gov Archive Site
may provide a basis for different therapeutic strategies [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops in Parkinson's Disease
Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops in Parkinson's Disease

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Parkinson's Disease
  • Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops
Other: subthalamo-cortical loops stimulation in a one-sided and bipolar way
Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients
  • Active Comparator: dopamine
    ON DOPA:The patient will take his usual treatment with dopamine
    Intervention: Other: subthalamo-cortical loops stimulation in a one-sided and bipolar way
  • Experimental: without dopa
    OFF Dopa: The patient will be deprived of his treatment usual dopaminergique for at least 12 hours
    Intervention: Other: subthalamo-cortical loops stimulation in a one-sided and bipolar way
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
Not Provided
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Bad tolerance of the condition OFF Dopa and\or OFF stimulation
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01284686
2009-A00913-54
No
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: Jean-Philippe AZULAY APHM
Assistance Publique Hopitaux De Marseille
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP