Overview

This trial is active, not recruiting.

Conditions parkinson's disease, pathophysiology of neuronal oscillations within subthalamo-cortical loops
Treatments subthalamo-cortical loops stimulation in a one-sided and bipolar way
Sponsor Assistance Publique Hopitaux De Marseille
Start date September 2010
End date March 2014
Trial size 20 participants
Trial identifier NCT01284686, 2009-A00913-54

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Arm
(Active Comparator)
ON DOPA:The patient will take his usual treatment with dopamine
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
(Experimental)
OFF Dopa: The patient will be deprived of his treatment usual dopaminergique for at least 12 hours
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

Primary Outcomes

Measure
the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD
time frame: 24 months

Secondary Outcomes

Measure
may provide a basis for different therapeutic strategies
time frame: 24 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops in Parkinson's Disease
Principal investigator Jean-Philippe AZULAY
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille.