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

Not Applicable

Completed

• Conditions: Parkinson's Disease; Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops
• Interventions: Other: subthalamo-cortical loops stimulation in a one-sided and bipolar way

• Registration Number: NCT01284686
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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).

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 Timeline

• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Study Start: 2012-03-26
• Primary Completion: 2015-05-27
• Study Completion: 2015-05-27
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
dopamine	subthalamo-cortical loops stimulation in a one-sided and bipolar way	ON DOPA:The patient will take his usual treatment with dopamine
without dopa	subthalamo-cortical loops stimulation in a one-sided and bipolar way	OFF Dopa: The patient will be deprived of his treatment usual dopaminergique for at least 12 hours

Primary Outcome Measures

Name	Time	Method
the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD	24 months

Secondary Outcome Measures

Name	Time	Method
may provide a basis for different therapeutic strategies	24 months

Trial Locations

Locations (1)

APHM; 🇫🇷 Marseille, France