Physiological Brain Atlas Development (Brain Atlas)
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|ClinicalTrials.gov Identifier: NCT00575081|
Recruitment Status : Recruiting
First Posted : December 17, 2007
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment|
|Parkinson's Disease Obsessive Compulsive Disorder Dystonia Essential Tremor Epilepsy||Device: Stereotactic brain procedures|
To create a brain atlas that will allow physiological and clinical information to be assigned to anatomical locations in MRI space, utilizing non-rigid MRI normalization algorithms. These data will specifically be acquired from the population of patients undergoing stereotactic brain procedures.
2. To collate and analyze the brain data placed in the atlas in a statistical manner that allows doctors to understand and treat brain disease more precisely and based on population data. For example, this would allow surgeons to predict optimal targeting locations for DBS implants, neurologists to program implants based on multiple physiological variables, including pre-operative severity of disease, intraoperative neurophysiological observations, and post-operative responses to previous therapies in a larger population of subjects.
3. To allow precise relationships to be visualized in one anonymized MRI volume, which can lead to new findings across larger populations of subjects in the field of brain science.
4. To locate all the data in a HIPAA compliant, anonymized location that clinicians and researchers can access securely without compromising personal healthcare information (PHI).
- 1. Patients who have consented to undergo or have undergone a stereotactic brain procedure for any reason will be asked to participate in this study.
- Permission from the patient will be sought to allow the entry of all related data to be entered into the atlas database. Specifically, this includes any and all related pre-operative, intra-operative, and post-operative clinical, radiographic, and psychologic testing done for the purposes of the surgery.
- The data must be entered in a confidential fashion and secured within a section of the database that can be accessed only by persons authorized to view patient healthcare information (PHI). Persons authorized to enter and view individual PHI must have taken and passed the CITI certification and presented documentation of this credential to the IRB study investigator (Dr. Konrad) or his Clinical Trials Specialist (Melba Isom).
- Access to individual patient data within the database can be done through a secure login linked to the person's qualifications to access PHI. The list of authorized persons (such as treating physicians and members of the surgical team) will be determined by Dr. Konrad and updated at least on an annual basis within the database by Dr. Dawant or Dr. D'Haese. Drs. Dawant / D'Haese will be responsible to ensure that PHI is physically and virtually secure within the atlas database.
- Once in the database, patient identifiers will be codified and not accessible for any queries outside of those certified in step 3. Non-patient specific information can be analyzed, sorted or queried in response to specific statistical questions by any investigator of the research team or authorized person, as designated by the database developer (Dr. Dawant) or his designee.
- Data contained within the atlas will be analyzed and regularly reported to members of the Atlas research team regarding accurate display and representation of the data.
- Clinical and physiological data will continue to be entered for every subject who consents to participate in this study for the duration of their care.
- If subjects no longer wish to have their data tracked within the atlas, they can call the study coordinator (Melba Isom) and have their name removed from any further data collection from the time of notification forward. All previously collected data will still be accessible and not expunged from the database.
- We plan to recruit 5,000 patients from Vanderbilt and participating sites.
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Physiological Brain Atlas Development|
|Study Start Date :||August 2006|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Stereotactic Brain Procedures
Patients who need Deep Brain Stimulation, GPi for Dystonia, and/or patients who have consented to undergo or have undergone a stereotactic brain procedure for any reason
Device: Stereotactic brain procedures
Stereotactic brain procedures
- To create an atlas that will allow physiological information to be assigned to anatomical locations in MRI space, utilizing non-rigid MRI normalization algorithms. [ Time Frame: life of study ]The above data will specifically be acquired from the population of patients undergoing Stereotactic Brain Surgery
- To collate and analyze the physiological atlas in a statistical manner that allows doctors to understand and treat brain disease more precisely and based on population data. [ Time Frame: life of study ]This is based on multiple physiological variables, including pre-operative severity of disease, intraoperative neurophysiological observations, and post-operative response to DBS stimulation therapy and brain disease requiring stereotactic procedures
- Assist surgical team intro-operatively [ Time Frame: life of study ]Assist the surgical team intro-operatively in making adjustments in the final DBS target location based on knowledge gained from population data contained within the atlas.
- Improve post-implant programming of DBS unit [ Time Frame: life of study ]Improve post-implant programming of the DBS unit based on atlas predictions of optimal zones of therapy; to allow precise relationships to be gvisualized in one anonymized MRI volume, which can lead to new findings across larger populations of subjects in the field of brain science
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575081
|Contact: Peter E Konrad, MD, Ph.D.||email@example.com|
|Contact: Melba T Isom, ASB, CCRPfirstname.lastname@example.org|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Contact: Peter E Konrad, MD, Ph.D. 615-343-9822 email@example.com|
|Contact: Melba T Isom 615-343-9822 firstname.lastname@example.org|
|Sub-Investigator: Benoit Dawant, Ph.D.|
|Sub-Investigator: Hong Yu, MD|
|Sub-Investigator: Changqing Kao, MD, Ph.D.|
|Sub-Investigator: Michael Remple, Ph.D.|
|Principal Investigator:||Peter E Konrad, MD, Ph.D.||Vanderbilt University, Dept. Neurosurgery|