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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital/Neuro Depart.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. impairment of cognition that leads unable to fully cooperate with the oral commands during operation,
  2. 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.,
  3. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
  1. To investigate the functional connectivity between the sub-thalamic nucleus and cerebral cortex on movement initiation and termination in PD patients.
  2. To examine phase leading roles of sub-thalamic nucleus and cerebral cortex in conducting volitional movements and will mainly focus on the movement termination.
after deep brain stimulation 4th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Medical University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Science Council, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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