- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00683566
State Dependent Resonance in the BG-cortical Loops
August 27, 2014 updated by: Assistance Publique Hopitaux De Marseille
Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronized 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.
So we hypothesize loop resonances in the 8-30 Hz frequency band at rest, which should be suppressed during movement and following dopaminergic therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Stimulate STN (at 0, 5, 10, 15, 20, 25, 30, 40, 70 and 130 Hz) in chronically implanted patients at rest and during simple and complex motor tasks while recording the steady state evoked potential over the cortex using EEG over the 19 sites of the classical 10/20 system and a channel to record artifact over the stimulator.
Experiments will be carried out both in the OFF medication and ON medication condition.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bouches Du Rhone
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Marseille, Bouches Du Rhone, France, 13005
- AP-HM Timone
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parkinson's disease idiopathic evolving for more than 5 years
- Electrodes of stimulation implanted in 2 nuclei under - thalamic in the service of functional and stereotaxic neurosurgery of the CHU La timone for at least 6 months
- Doped sensibility superior to 50 % (estimated by the section III of the score UPDRS)
- Efficiency of the stimulation superior to 30 % (estimated by the section III of the score UPDRS)
Exclusion Criteria:
- Patients not verifying the criteria of inclusion
- Absence of data concerning the location of electrodes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
A session in condition ON DOPAMINE and the other one in condition OFF DOPAMINE.
|
Stimulate STN (at 0, 5, 10, 15, 20, 25, 30, 40, 70 and 130 Hz) in chronically implanted patients at rest and during simple and complex motor tasks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The results are expected to bring further light into the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD and may provide a basis for different therapeutic strategies.
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: jean philippe AZULAY, MD, AP-HM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (ACTUAL)
February 1, 2010
Study Completion (ACTUAL)
December 1, 2010
Study Registration Dates
First Submitted
February 26, 2008
First Submitted That Met QC Criteria
May 22, 2008
First Posted (ESTIMATE)
May 23, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
August 28, 2014
Last Update Submitted That Met QC Criteria
August 27, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-A01178-45
- 2007 36
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.