Parkinson DiseaseNCT03079037
Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Project 1 Aim 2 and 3
An observational study of Parkinson Disease, run by University of Minnesota at 1 site in United States.
Trial summary
This study will test the hypothesis that deep brain stimulation (DBS) targeting specific changes in oscillatory activity at the site of stimulation will prove superior to continuous isochronal DBS thus providing the rationale for development and optimization of closed loop paradigms and determine whether the optimal… Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Stimulation
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to 29 Jan 2023
- 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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's Disease (PD)
Who may be able to join
- Diagnosis of idiopathic PD
- DBS surgery or IPG battery replacement at UMN is planned as part of routine clinical care.
Who cannot join
- Other significant neurological disorder
- History of dementia
- Prior history of stereotactic neurosurgery
- Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
This study will test the hypothesis that deep brain stimulation (DBS) targeting specific changes in oscillatory activity at the site of stimulation will prove superior to continuous isochronal DBS thus providing the rationale for development and optimization of closed loop paradigms and determine whether the optimal closed-loop biomarker varies across subcortical targets, is task dependent, or serves to re-establish a default network that removes an underlying disruptive physiological state leading to greater improvement in motor signs and task performance.
- Conditions
- Parkinson Disease
- Being tested
- Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimulationDevice
Traditional deep brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| Stimulation | Traditional deep brain stimulation Receives: Device: Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure local field potential (LFP) changes in subthalamic nucleus (STN) and globus pallidus (GP) in OFF and ON states of stimulation and medication
Clinical ratings scales (MDS-UPDRS)
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start19 Jun 2018
- Primary completion29 Jan 2023
- Study completion29 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael C. Park, MD/PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079037
- Sponsor's protocol ID
- NEUR-2016-22287
- Status last verified
- Apr 2024
- First submitted
- 24 Feb 2017
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Project 1 Aim 2 and 3
- ClinicalTrials.gov ID
- NCT03079037
- Acronym / sponsor ID
- NEUR-2016-22287
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 29 Jan 2023 (actual)
- Study completion
- 29 Jan 2023 (actual)
- First posted
- 14 Mar 2017 (actual)
- 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.
This study will test the hypothesis that deep brain stimulation (DBS) targeting specific changes in oscillatory activity at the site of stimulation will prove superior to continuous isochronal DBS thus providing the rationale for development and optimization of closed loop paradigms and determine whether the optimal closed-loop biomarker varies across subcortical targets, is task dependent, or serves to re-establish a default network that removes an underlying disruptive physiological state leading to greater improvement in motor signs and task performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stimulation | – | Device: StimulationTraditional deep brain stimulation |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's Disease (PD)
Key inclusion criteria (2 listed)
- Diagnosis of idiopathic PD
- DBS surgery or IPG battery replacement at UMN is planned as part of routine clinical care.
Key exclusion criteria (5 listed)
- Other significant neurological disorder
- History of dementia
- Prior history of stereotactic neurosurgery
- Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
- Pregnant women
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 |
|---|---|---|
| StimulationTraditional deep brain stimulation | Device | Stimulation |
Primary outcome
Measure local field potential (LFP) changes in subthalamic nucleus (STN) and globus pallidus (GP) in OFF and ON states of stimulation and medication
Time frame: 2 days
Clinical ratings scales (MDS-UPDRS)
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 16 Apr 2024.
Related trials for Parkinson Disease
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Recruiting
Effects of Microelectrode-based Brain Stimulation in Humans
Essential Tremor, Parkinsons Disease (PD)
Not yet recruitingPhase 1
Stanford University Neurofiber Study
PARKINSON DISEASE (Disorder)
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
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.
Michael C. Park, MD/PhD principal investigator
University of Minnesota
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 Minnesota 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 2 inclusion and 5 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 16 Apr 2024. 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?
Measure local field potential (LFP) changes in subthalamic nucleus (STN) and globus pallidus (GP) in OFF and ON states of stimulation and medication (time frame: 2 days). 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 16 Apr 2024.