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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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

About this trial

This is an interventional other trial for Parkinson's Disease focused on measuring Pathophysiology, Parkinson, neuronal oscillations

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

APHM

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

dopamine

without dopa

Arm Description

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

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

Outcomes

Primary Outcome Measures

the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD

Secondary Outcome Measures

may provide a basis for different therapeutic strategies

Full Information

NCT ID

NCT01284686

First Posted

January 26, 2011

Last Updated

July 27, 2022

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT01284686

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

March 26, 2012 (Actual)

Primary Completion Date

May 27, 2015 (Actual)

Study Completion Date

May 27, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Pathophysiology, Parkinson, neuronal oscillations

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dopamine

Arm Type

Active Comparator

Arm Description

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

Arm Title

without dopa

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD

Time Frame

24 months

Secondary Outcome Measure Information:

Title

may provide a basis for different therapeutic strategies

Time Frame

24 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Philippe AZULAY

Organizational Affiliation

APHM

Official's Role

Principal Investigator

Facility Information:

Facility Name

APHM

City

Marseille

ZIP/Postal Code

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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