Physiological Brain Atlas Development
The NIH grant has funded the development of a physiological brain atlas registry that will allow us to significantly improve the targeting and use of DBS implants for Parkinson's Disease, Dystonia, Essential Tremor, and OCD.
Device: Deep Brain Stimulator
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Physiological Brain Atlas Development|
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||July 2020|
Deep Brain Stimulation
Patients who need Deep Brain Stimulation, GPi for Dystonia
Device: Deep Brain Stimulator
Deep Brain Stimulation, GPi for Dystonia
Other Name: Medtronic Deep Brain Stimulator, GPi for Dystonia
- To create an atlas that will allow physiological 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 DBS implantation at Vanderbilt University.
- To collate and analyze 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.
- Assist the surgical team intra-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 the DBS unit based on atlas predictions of optimal zones of therapy.
- Patients who have consented to undergo or have undergone a DBS implant 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 DBS 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 assistant (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. Dr. Dawant's responsibility will be 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.
- Targeting for DBS therapy will be analyzed and regularly reported to members of the neurosurgical DBS team regarding accuracy, symptomatic improvement, and any evidence for problems that may appear with inappropriately targeted therapy.
- Atlas guidance for intraoperative adjustments will be evaluated based on the number of passes made to achieve target and whether the atlas predicted the correct physiological response after an adjustment in location was made.
- Post-operative programming of the DBS implant will be evaluated with respect to contact location and predicted therapeutic goals based on the atlas. Regular updates regarding optimization of possible improved contact selection will be passed on the clinicians involved in the programming of the DBS implant.
- Clinical and physiological data will continue to be entered for every patient who consents to participate in this study for the duration of their care at Vanderbilt University.
|Contact: Peter E Konrad, MD, Ph.D.||firstname.lastname@example.org|
|Contact: Melba T Isomemail@example.com|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Contact: Peter E Konrad, MD, Ph.D. 615-343-9822 firstname.lastname@example.org|
|Contact: Melba T Isom 615-343-9822 email@example.com|
|Sub-Investigator: Benoit Dawant, Ph.D.|
|Sub-Investigator: Joseph S Neimat, MD, MS|
|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|