Parkinson DiseaseNCT01113684
Study of Subthalamic Brain Stimulation in Parkinson Disease (PD)
An observational study of Parkinson Disease, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Deep brain stimulation (DBS) improves debilitating symptoms of movement disorders when conventional medical therapies and novel surgical therapies fail. Despite the remarkable efficacy of DBS, its therapeutic mechanism remains unclear. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Implantable pulse generator (deep brain stimulator)
- Type of treatment
- Medical device
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Nov 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's disease who have undergone subthalamic deep brain stimulation
Who may be able to join
- Patients with Parkinson disease who have undergone subthalamic deep brain stimulation
Who cannot join
- Patients who are unable to follow verbal instructions
- Patients who are unable to tolerate being off their Parkinson's medications for 12 hours
- Patients who are medically unstable
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Clinical and Neurophysiological Study of Subthalamic Brain Stimulation in PD
Deep brain stimulation (DBS) improves debilitating symptoms of movement disorders when conventional medical therapies and novel surgical therapies fail. Despite the remarkable efficacy of DBS, its therapeutic mechanism remains unclear. There is controversy regarding whether the therapeutic effects of DBS are associated with inhibition or excitation of target neurons, the introduction of new activity into the network, or a combination of these mechanisms. Additionally, it is unclear why stimulus frequency plays an important role in the clinical response to therapy. The fundamental hypothesis of this proposal is that unilateral subthalamic nucleus (STN) DBS in PD alters neuronal activity in the bilateral basal ganglia-thalamic-cortical motor system in a manner that is dependent on stimulation frequency.
- Conditions
- Parkinson Disease
- Being tested
- Implantable pulse generator (deep brain stimulator)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable pulse generator (deep brain stimulator)Device
Also called Soletra Implantable Pulse Generator (Medtronic, Inc.), Kinetra Implantable Pulse Generator (Medtronic, Inc.), Activa PC Implantable Pulse Generator (Medtronic, Inc.), Activa RC Implantable Pulse Generator (Medtronic, Inc.)
This study evaluates the effects of subthalamic deep brain stimulation on central and peripheral nervous system activity in patients who have already had brain stimulators placed as a matter of routine clinical care.
What is being measured
The primary outcome is the main question the study is designed to answer.
This study measures neurophysiological responses to subthalamic deep brain stimulation in the central and peripheral nervous system in patients with Parkinson disease.
Measured: Population data will be analyzed for the primary endpoint in 12 months and reported in approximately 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harrison Walker, MD, University of Alabama at Birmingham
- Investigators
- Harrison C Walker, MD, Principal investigator, University of Alabama at Birmingham, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113684
- Sponsor's protocol ID
- F091215017
- Other IDs
- 1K23NS067053-01
- Status last verified
- May 2018
- First submitted
- 26 Apr 2010
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Walker HC, Watts RL, Guthrie S, Wang D, Guthrie BL. Bilateral effects of unilateral subthalamic deep brain stimulation on Parkinson's disease at 1 year. Neurosurgery. 2009 Aug;65(2):302-9; discussion 309-10. doi: 10.1227/01.NEU.0000349764.34211.74.
PubMed 19625909
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Neurophysiological Study of Subthalamic Brain Stimulation in PD
- ClinicalTrials.gov ID
- NCT01113684
- Acronym / sponsor ID
- F091215017
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Feb 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Apr 2010 (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.
Deep brain stimulation (DBS) improves debilitating symptoms of movement disorders when conventional medical therapies and novel surgical therapies fail. Despite the remarkable efficacy of DBS, its therapeutic mechanism remains unclear. There is controversy regarding whether the therapeutic effects of DBS are associated with inhibition or excitation of target neurons, the introduction of new activity into the network, or a combination of these mechanisms. Additionally, it is unclear why stimulus frequency plays an important role in the clinical response to therapy. The fundamental hypothesis of this proposal is that unilateral subthalamic nucleus (STN) DBS in PD alters neuronal activity in the bilateral basal ganglia-thalamic-cortical motor system in a manner that is dependent on stimulation frequency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease who have undergone subthalamic deep brain stimulation
Key inclusion criteria (1 listed)
- Patients with Parkinson disease who have undergone subthalamic deep brain stimulation
Key exclusion criteria (3 listed)
- Patients who are unable to follow verbal instructions
- Patients who are unable to tolerate being off their Parkinson's medications for 12 hours
- Patients who are medically unstable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable pulse generator (deep brain stimulator)Also: Soletra Implantable Pulse Generator (Medtronic, Inc.), Kinetra Implantable Pulse Generator (Medtronic, Inc.), Activa PC Implantable Pulse Generator (Medtronic, Inc.), Activa RC Implantable Pulse Generator (Medtronic, Inc.)This study evaluates the effects of subthalamic deep brain stimulation on central and peripheral nervous system activity in patients who have already had brain stimulators placed as a matter of routine clinical care. | Device | – |
Primary outcome
This study measures neurophysiological responses to subthalamic deep brain stimulation in the central and peripheral nervous system in patients with Parkinson disease.
Time frame: Population data will be analyzed for the primary endpoint in 12 months and reported in approximately 18 months.
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 11 May 2018.
- Background: PubMed 19625909Walker HC, Watts RL, Guthrie S, Wang D, Guthrie BL. Bilateral effects of unilateral subthalamic deep brain stimulation on Parkinson's disease at 1 year. Neurosurgery. 2009 Aug;65(2):302-9; discussion 309-10. doi: 10.1227/01.NEU.0000349764.34211.74.
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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.
Harrison C Walker, MD principal investigator
University of Alabama at Birmingham, Department of Neurology
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 Disease, run by University of Alabama at Birmingham at 1 site in United States.
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 11 May 2018. 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 United States. 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?
This study measures neurophysiological responses to subthalamic deep brain stimulation in the central and peripheral nervous system in patients with Parkinson disease. (time frame: Population data will be analyzed for the primary endpoint in 12 months and reported in approximately 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01113684, which also lists 1 linked publication.
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 11 May 2018.