- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01774383
Investigating the Pathophysiological Roles of Cortical, Sub-thalamic Nuclear and Pedunculo-pontine Nuclear Oscillation in Movement Termination of Parkinson Disease Patients
January 29, 2014 updated by: Chon-Haw Tsai, China Medical University Hospital
The ERD and ERS patterns of coordination between the STN and cortical regions in the termination of volitional movement in PD patients.
Study Overview
Status
Completed
Conditions
Detailed Description
The project will investigate the roles of cortical regions, sub-thalamic nucleus and pedunculo-pontine nucleus in the preparation of volitional movement termination in patients with Parkinson's disease (PD)receiving deep brain stimulation.
Currently there are two models of inhibitory preparation of volitional movements.
The "withdrawal mechanism" posits the explanation that movement termination is due to the"shutting off" of the activated neuralcircuitry, whereas the "inhibition mechanism" suggests that inhibitory neural structures are activated to terminate the voluntary movement.
These hypotheses were deduced from the study of scalp movement-related cortical potential recordings and how the deep structures involved in the execution in movement termination is uncertain.
Movement preparation prior to movement onset (Mon) has been addressed in both scalp recordings of MRCP and from recent studies of STN in PD patients.
However,the electro-physiologic information concerning the role of STN in the preparation of movement offset (Moff)is less understood.
In our pilot study, we have found that high-beta event-related de-synchronization (ERD)appeared earlier (3 seconds prior to Mon) than those of low-beta and alpha for the Mon phasic movement.There was no alpha ERD for the Mon tonic movement.
Alpha, low-beta, and high-beta ERD all appeared about 1 second prior to the Moff tonic movement.
These findings suggest that STN participates in the preparation of volitional movement termination but via different mechanism from that in movement initiation.Unlike asynchronous ERD frequency bands present in movement initiation, a simultaneous ERD across wide frequency bands in STN may play a pivotal role in terminating volitional movement.
Since there is tight connection between the cortical regions and STN, it is intriguing to know the relationship of these oscillatory patterns between the deep and superficial neural structures.
In the current proposal, we will examine the patterns of ERD and ERS prior to Mon and Moff of tonic movements in both cortical and STN regions and determine the temporal relationship among them.
Study Type
Observational
Enrollment (Actual)
3
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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Taichung, Taiwan, 40447
- China Medical University Hospital/Neuro Depart.
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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
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
PD undergoing deep brain stimulation of the sub-thalamic nucleus.
Description
Inclusion Criteria:
Patients with PD undergoing deep brain stimulation. The inclusion criteria for the patient selection will be those with motor complications (wearing off, on-off, drug-induced dyskinesia). Levodopa challenge test will be conducted to ensure good beneficial response of medication in each patient, since this is a reliable indicator to predict the DBS effect.
Exclusion Criteria:
- impairment of cognition that leads unable to fully cooperate with the oral commands during operation,
- any moderate to severe medical disorders such as poor control of diabetic mellitus, functional III or above congestive heart failure, or cancer with distant metastasis etc.,
- severe mood disorders such as major depression.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The ERD and ERS patterns of coordination between the STN and cortical regions in the termination of volitional movement in PD patients.
Time Frame: after deep brain stimulation 4th day
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after deep brain stimulation 4th day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chon-Haw Tsai, MD, PHD, Department of Neurology, China Medical University Hospital, Taichung, Taiwan
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
August 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
January 21, 2013
First Submitted That Met QC Criteria
January 23, 2013
First Posted (Estimate)
January 24, 2013
Study Record Updates
Last Update Posted (Estimate)
January 30, 2014
Last Update Submitted That Met QC Criteria
January 29, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMR101-IRB2-005
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.
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