Parkinson's Disease; Deep Brain StimulationNCT01774383
Investigating the Pathophysiological Roles of Cortical, Sub-thalamic Nuclear and Pedunculo-pontine Nuclear Oscillation in Movement Termination of Parkinson Disease Patients
An observational study of Parkinson's Disease; Deep Brain Stimulation, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The ERD and ERS patterns of coordination between the STN and cortical regions in the termination of volitional movement in PD patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Parkinson's Disease; Deep Brain Stimulation
- How many people
- 3 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PD undergoing deep brain stimulation of the sub-thalamic nucleus.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
China Medical University Hospital/Neuro Depart.
Taichung, Taiwan, 40447
About this study
The ERD and ERS patterns of coordination between the STN and cortical regions in the termination of volitional movement in PD patients.
Read the 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.
- Keywords
- Parkinson's disease, sub-thalamic nucleus, oscillation, local field potential
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The ERD and ERS patterns of coordination between the STN and cortical regions in the termination of volitional movement in PD patients.
- To investigate the functional connectivity between the sub-thalamic nucleus and cerebral cortex on movement initiation and termination in PD patients.
- To examine phase leading roles of sub-thalamic nucleus and cerebral cortex in conducting volitional movements and will mainly focus on the movement termination.
Measured: after deep brain stimulation 4th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease; Deep Brain StimulationStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Chon-Haw Tsai, China Medical University Hospital
- Investigators
- Chon-Haw Tsai, MD, PHD, Principal investigator, Department of Neurology, China Medical University Hospital, Taichung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774383
- Sponsor's protocol ID
- DMR101-IRB2-005
- Status last verified
- Jan 2014
- First submitted
- 21 Jan 2013
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Pathophysiological Roles of Cortical, Sub-thalamic Nuclear and Pedunculo-pontine Nuclear Oscillation in Movement Termination of Parkinson Disease Patients
- ClinicalTrials.gov ID
- NCT01774383
- Acronym / sponsor ID
- DMR101-IRB2-005
- Keywords
- Parkinson's disease, sub-thalamic nucleus, oscillation, local field potential
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ERD and ERS patterns of coordination between the STN and cortical regions in the termination of volitional movement in PD patients.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PD undergoing deep brain stimulation of the sub-thalamic nucleus.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chon-Haw Tsai, MD, PHD principal investigator
Department of Neurology, China Medical University Hospital, Taichung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease; Deep Brain Stimulation, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2014.