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

NCT ID: NCT01284686

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-26

Study Completion Date

2015-05-27

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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dopamine

ON DOPA:The patient will take his usual treatment with dopamine

Group Type ACTIVE_COMPARATOR

subthalamo-cortical loops stimulation in a one-sided and bipolar way

Intervention Type OTHER

Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients

without dopa

OFF Dopa: The patient will be deprived of his treatment usual dopaminergique for at least 12 hours

Group Type EXPERIMENTAL

subthalamo-cortical loops stimulation in a one-sided and bipolar way

Intervention Type OTHER

Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Philippe AZULAY

Role: PRINCIPAL_INVESTIGATOR

APHM

Locations

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APHM

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2009-A00913-54

Identifier Type: -

Identifier Source: org_study_id

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