Parkinson DiseaseNCT01210534
Physiological Brain Atlas Development
An observational study of Parkinson Disease and Dystonia, run by Ohio State University at 1 site in United States.
Trial summary
Enrollment of candidates undergoing a deep brain stimulator (DBS) implant. Read more about this study
- Who is it for?
- Ages 7 to 90 years
- Conditions the study is for
- Parkinson Disease, Dystonia, Tremors
- How many people
- 456 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to 18 Oct 2021
- 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 7 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who are undergoing DBS implantation surgery at the Ohio State University.
Who may be able to join
- Any patient between the age of 7-90
- Patients who have undergone deep brain stimulation (DBS) surgery as standard of care at The Ohio State University
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Enrollment of candidates undergoing a deep brain stimulator (DBS) implant.
Read the detailed description
The study proposes the enrollment of candidates undergoing a deep brain stimulator (DBS) implant. Data will be collected before, during and after surgery and will be electronically entered into the Atlas database where it will be stored indefinitely.
The purpose of the study is to create an Atlas to store physiological information utilizing non-rigid MRI normalization algorithms. In addition to collating and analyzing the physiological atlas in a statistical manner that allows the surgeon to predict optimal targeting locations for DBS implants based on multiple physiological variables, including pre-operative severity of disease, intraoperative neurophysiological observations, and post-operative response to DBS stimulation therapy.
- Conditions
- Parkinson Disease, Dystonia, Tremors, Obsessive Compulsive Disorder, Depression
- Being tested
- No intervention
- Medical subject headings
- Parkinson Disease, Dystonia, Tremor, Obsessive-Compulsive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Also called Single Arm Group
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
optimal DBS target location
To create an atlas that will allow physiological information to be assigned to anatomical locations in MRI space, utilizing non-rigid MRI normalization algorithms.
Measured: intra-operative identification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startAug 2010
- Primary completion31 Aug 2021
- Study completion18 Oct 2021
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 Ohio State UniversityThe 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
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vibhor Krishna, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210534
- Sponsor's protocol ID
- 2010H0036
- Status last verified
- Feb 2023
- First submitted
- 27 Sep 2010
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Brain Atlas Development
- ClinicalTrials.gov ID
- NCT01210534
- Acronym / sponsor ID
- 2010H0036
- Conditions
- Parkinson Disease, Dystonia, Tremors, Obsessive Compulsive Disorder, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 28 Sep 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.
Enrollment of candidates undergoing a deep brain stimulator (DBS) implant.
Detailed description
The study proposes the enrollment of candidates undergoing a deep brain stimulator (DBS) implant. Data will be collected before, during and after surgery and will be electronically entered into the Atlas database where it will be stored indefinitely.
The purpose of the study is to create an Atlas to store physiological information utilizing non-rigid MRI normalization algorithms. In addition to collating and analyzing the physiological atlas in a statistical manner that allows the surgeon to predict optimal targeting locations for DBS implants based on multiple physiological variables, including pre-operative severity of disease, intraoperative neurophysiological observations, and post-operative response to DBS stimulation therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who are undergoing DBS implantation surgery at the Ohio State University.
Key inclusion criteria (2 listed)
- Any patient between the age of 7-90
- Patients who have undergone deep brain stimulation (DBS) surgery as standard of care at The Ohio State University
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No interventionAlso: Single Arm GroupNo intervention | Other | – |
Primary outcome
optimal DBS target location
Time frame: intra-operative identification
To create an atlas that will allow physiological information to be assigned to anatomical locations in MRI space, utilizing non-rigid MRI normalization algorithms.
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 13 Feb 2023.
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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.
Vibhor Krishna, MD principal investigator
Ohio State University
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 and Dystonia, run by Ohio State University 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 1 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 13 Feb 2023. 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?
optimal DBS target location (time frame: intra-operative identification). 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 13 Feb 2023.